Compresión neumática intermitente de la pierna y profilaxis farmacológica combinadas para la profilaxis de la tromboembolia venosa en pacientes de alto riesgo
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en curso
Referencias adicionales
Referencias de otras versiones publicadas de esta revisión
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Countries: Saudi Arabia, Canada, Australia, and India | |
| Interventions | Intervention group: IPC and heparin (any type) | |
| Outcomes | Primary outcome: incident (i.e. new) proximal lower‐limb DVT, as detected on twice‐weekly lower‐limb US after the third calendar day since randomisation until ICU discharge, death, attainment of full mobility, or study day 28, whichever occurred first. DVT that were detected on study days 1 to 3 were considered to be prevalent (i.e. pre‐existing) and were not included in the primary outcome analysis Secondary outcomes: percentage of participants who had prevalent proximal DVT, the occurrence of any lower limb DVT thromboses (proximal, distal, prevalent, or incident), the occurrence of PE, a composite outcome of VTE that included PE or all prevalent and incident lower‐limb DVT, a composite outcome of VTE or death from any cause at 28 days, and safety outcomes | |
| Funding | Grants from King Abdulaziz City for Science and Technology (AT 34‐65) and King Abdullah International Medical Research Center (RC12/045/R) | |
| Declarations of interest | MH reports receiving payment for patient cost, US and start‐up fees | |
| Notes | The modified ITT population comprised all the participants who underwent randomisation with the exception of those who withdrew consent for both the intervention and the collection of data and those who were identified as ineligible after randomisation. The single case of fatal PE was observed in the control group (personal communication). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation system |
| Allocation concealment (selection bias) | Low risk | Centralised computer‐generated randomisation system with variable block size |
| Blinding of participants and personnel (performance bias) | High risk | No placebo IPC was used |
| Blinding of outcome assessment (detection bias) | Unclear risk | Unclear if outcome assessors of adjudicating committee (if any) were blinded to allocation group, with the exception of radiologists who interpreted US findings |
| Incomplete outcome data (attrition bias) | Low risk | Relatively few exclusions |
| Selective reporting (reporting bias) | Low risk | None detected |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: CCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: SCDs with elastic stockings and UFH (5000 IU twice daily, sc) | |
| Outcomes | Symptomatic PE, confirmed with ventilation‐perfusion scan | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | The study was planned to be randomised but due to administrative errors the randomisation protocol was violated SCDs were started in the operating room and discontinued when the participants were ambulatory, usually 18 h postoperatively Heparin was started 2 h before the operation and was continued for 7 days or the time of discharge Study was discontinued because of bleeding complications associated with heparin use. No specific bleeding definitions were provided. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | The study was planned to be randomised but due to administrative errors the randomisation protocol was violated. Method of planned randomisations was stated as patient order |
| Allocation concealment (selection bias) | High risk | Alternating patients received the study medication and in most cases the surgeon was aware of which participants received heparin |
| Blinding of participants and personnel (performance bias) | High risk | In most cases the surgeon was aware of which participants received heparin, and the same perhaps applies to the anaesthesia personnel |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel performing the pulmonary ventilation‐perfusion scans or angiograms were aware of which participants received heparin |
| Incomplete outcome data (attrition bias) | Low risk | No participants were lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | PE was the only VTE event stated in methodology and was reported |
| Other bias | Unclear risk | No baseline characteristics, apart from age, were provided |
| Study characteristics | ||
| Methods | Study design: CCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: SCDs and pharmacological prophylaxis (UFH or coumadin) | |
| Outcomes | DVT diagnosed with I‐125 fibrinogen scanning, IPG, Doppler US and venography | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | Participants who received aspirin or dextran as an exclusive pharmacological modality or elastic stockings as an exclusive mechanical modality were not included in our review. All modalities were started with the preoperative medication and continued until the participants were well ambulatory. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Patients were placed into each category in rotation by the vascular technicians. |
| Allocation concealment (selection bias) | High risk | No details on the allocation procedure were provided. |
| Blinding of participants and personnel (performance bias) | High risk | Placebo medications or devices were not used. |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel performing DVT testing were aware of which participants received heparin. |
| Incomplete outcome data (attrition bias) | Low risk | All participants had an event reported. |
| Selective reporting (reporting bias) | Low risk | DVT was the only VTE event stated in methodology and was reported. |
| Other bias | Unclear risk | No baseline characteristics were provided. |
| Study characteristics | ||
| Methods | Study design: CCT | |
| Participants | Country: UK | |
| Interventions | Intervention group: UFH (5000 IU twice daily, sc) with GCS (TEDs), and pneumatic foot compression on the side to be operated on | |
| Outcomes | DVT on bilateral lower extremity venography performed postoperative day 12 | |
| Funding | IPC devices provided by the Novamedix Ltd | |
| Declarations of interest | Not reported | |
| Notes | The foot pump started at the beginning of surgery and continued until discharge from the hospital. No details were provided for heparin | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Patients with an even date of birth were randomised to receive IPC |
| Allocation concealment (selection bias) | High risk | Patients with an even date of birth were allocated to receive IPC ‐ allocation therefore predictable |
| Blinding of participants and personnel (performance bias) | High risk | No placebo device was used |
| Blinding of outcome assessment (detection bias) | Low risk | The radiologist who read the venograms was blinded to participant allocation |
| Incomplete outcome data (attrition bias) | Low risk | All study participants were reported in the results section |
| Selective reporting (reporting bias) | Low risk | DVT was the only VTE outcome event stated in methodology and was reported |
| Other bias | Low risk | Baseline characteristics were comparable |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: UFH (5000 IU twice daily) and thigh‐length sequential pneumatic compression (Kendall Health Care, Manchester, Mass, USA) | |
| Outcomes | DVT on DUS and also clinically evident DVT and PE | |
| Funding | Not reported | |
| Declarations of interest | None | |
| Notes | Investigation on the effect of study interventions on fibrinolytic activity, but also reported VTE outcomes DVT prophylaxis was initiated in the operating room after induction of anaesthesia and continued until postoperative day 5 (or discharge, if this occurred sooner). If the participant remained hospitalised after postoperative day 5, DVT prophylaxis was left to the discretion of the primary surgeon, and the participant was no longer participating in the research study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) | High risk | No placebo anticoagulants or IPC devices were used |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel who performed the DVT screening were blinded to the treatment regimens |
| Incomplete outcome data (attrition bias) | Low risk | All study participants were reported in the results section |
| Selective reporting (reporting bias) | Low risk | DVT was the only VTE outcome event stated in methodology and was reported |
| Other bias | Low risk | No significant baseline imbalances |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: LMWH enoxaparin (Lovenox; Rhône‐Poulenc Rorer Pharmaceuticals) sc at a dose of 30 mg in the anaesthesia holding room, and continued at a dose of 30 mg twice daily combined with IPC (thigh‐high SCDs (Kendall), functioning on the patient before induction of anaesthesia | |
| Outcomes | DVT on DUS between days 1 and 3, between days 5 and 7, at the wound check appointment between days 10 and 14, and at the 1‐month follow‐up appointment Incidence of adverse events (including bleeding) was assessed by principal investigator by thorough review of medical records. No specific bleeding definitions were provided | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | The IPC devices functioned throughout the surgical procedure and remained on the participant during the postoperative period, until the participant was walking without assistance. If the participant remained nonambulatory, the devices were discontinued at the time of discharge from the Neurosurgery Service. Enoxaparin was started in the anaesthesia holding room and was discontinued at the time of discharge from the Neurosurgery Service. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) | High risk | No placebo anticoagulants or IPC devices were used |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel who performed the DVT screening were blinded to the treatment regimens |
| Incomplete outcome data (attrition bias) | Low risk | All study participants were reported in the results section |
| Selective reporting (reporting bias) | Low risk | DVT was the only VTE outcome event stated in methodology and was reported |
| Other bias | High risk | The study stopped early (enrolment was planned for 120 participants) |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: China | |
| Interventions | Intervention group: IPC with elastic stockings and LMWH nadroparin | |
| Outcomes | Primary end points: incidence of PE, DVT, and the PESI of PE patients. CTPA and extremity venous Doppler US were performed in all patients on POD 7. Simultaneously, patients diagnosed with PE by radiologist through CTPA were assessed using the PESI Secondary end points: haemoglobin, PLT, D‐dimer (mcg/L), the PO2/FiO2 ratio (P/F) at POD 7 and the chest drainage time and the LOS in hospital after operation | |
| Funding | Not reported | |
| Declarations of interest | None | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) | High risk | No use of placebo |
| Blinding of outcome assessment (detection bias) | High risk | No use of placebo. Exception for PE (low risk) |
| Incomplete outcome data (attrition bias) | High risk | Large number of exclusions |
| Selective reporting (reporting bias) | Low risk | Results were provided for all outcomes |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: LMWH enoxaparin (30 mg twice daily, starting the morning after surgery for 7‐8 days) combined with IPC (CECT device, ActiveCare DVT; Medical Compression Systems, Or Akiva, Israel) with calf sleeves | |
| Outcomes | DVT on DUS before discharge and also clinically evident DVT and PE at 3 months | |
| Funding | Received from Medical Compression Active Care DVT, Medical Compression Systems | |
| Declarations of interest | Benefits received from Medical Compression Active Care DVT, Medical Compression Systems | |
| Notes | IPC was placed on the calves of the participant in the operating room and continued during hospitalisation | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) | High risk | No placebo devices were used |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel who performed the DVT screening were blinded to the treatment regimens |
| Incomplete outcome data (attrition bias) | Low risk | All study participants were reported in the results section |
| Selective reporting (reporting bias) | Low risk | DVT and PE were VTE events stated in methodology and were reported |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Germany | |
| Interventions | Intervention group: LMWH certoparin (3000 IU 12 h pre‐op, 12 post‐op then daily, sc), compression stockings (18‐20 mmHg), and rapid‐inflation IPC | |
| Outcomes | Symptomatic DVT and DVT on colour‐coded DUS performed on the day of discharge | |
| Funding | Received from Aircast Europe | |
| Declarations of interest | Funding received from the manufacturer by "one or more of the authors" | |
| Notes | Quote: "The DVT prophylaxis regimen was randomly assigned in the operating theatre at the time of completion of surgery and the randomisation was stratified by age." No information on PE was provided Participants in the IPC group had the IPC system applied to both calves in the recovery room shortly after the completion of surgery. IPC therapy was applied daily during the time that the participant was confined to bed postoperatively, and it was terminated at the time that the participant was able to walk LMWH was started 12 h preoperatively and continued throughout hospitalisation | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided, apart from the information that it was stratified by patient age, so that we can make an assumption that they used a computer‐generated sequence or the sealed envelope method |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) | High risk | No placebo device was used |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel who performed the DVT screening were blinded to the treatment regimens |
| Incomplete outcome data (attrition bias) | Low risk | All study participants were reported in the results section |
| Selective reporting (reporting bias) | Low risk | DVT was the only VTE event stated in methodology and was reported |
| Other bias | Low risk | Baseline number of risk factors for DVT per participant were comparable |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Japan | |
| Interventions | Intervention group: IPC with elastic stockings and anticoagulation (fondaparinux or enoxaparin) | |
| Outcomes | Primary endpoint: incidence of VTE Secondary endpoint: incidence of major bleeding | |
| Funding | None | |
| Declarations of interest | None | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Central randomisation |
| Allocation concealment (selection bias) | Low risk | Central concealment |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study without use of placebo |
| Blinding of outcome assessment (detection bias) | High risk | Open‐label study without use of placebo, with the exception of PE (the radiologist interpreted the CT scans without any identifying information about the patients) |
| Incomplete outcome data (attrition bias) | Low risk | No attrition |
| Selective reporting (reporting bias) | Low risk | Results provided for all outcomes |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Korea | |
| Interventions | Intervention group: IPC and LMWH enoxaparin | |
| Outcomes | DVT, on DUS but also clinically evident DVT, and PE Bleeding: major and minor | |
| Funding | Funded by Covidien and Medtronic | |
| Declarations of interest | None | |
| Notes | An interim analysis was published in 2014 (Song 2014), which was included in the previous version of this review | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐randomised treatment assignments |
| Allocation concealment (selection bias) | High risk | Sequential sealed envelopes, but no statement that these were opaque |
| Blinding of participants and personnel (performance bias) | High risk | No placebo injection was given |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel performing diagnostic testing were aware of participant allocation |
| Incomplete outcome data (attrition bias) | High risk | A relatively large number of participants in the combined group did not have DUS |
| Selective reporting (reporting bias) | Low risk | DVT and PE were stated in methodology to be the outcome measures of the study and results were reported |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Japan | |
| Interventions | Intervention group: IPC and LMWH enoxaparin | |
| Outcomes | Primary outcome: VTE (DVT and PE), both symptomatic and asymptomatic, diagnosed by multidetector CT on POD 7 Secondary outcome: bleeding | |
| Funding | Reported as not funded, however, the primary investigator of the study received research support from Kaken Pharmaceutical, Tokyo, Japan, a company that had a co‐marketing agreement for the anticoagulant enoxaparin used in the experimental group of the study | |
| Declarations of interest | AT reported receiving research support as the primary investigator from Kaken Pharmaceutical, Tokyo, Japan | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Central computer‐generated randomisation |
| Allocation concealment (selection bias) | Low risk | Central computer‐generated randomisation |
| Blinding of participants and personnel (performance bias) | High risk | Blinding was considered to be impossible |
| Blinding of outcome assessment (detection bias) | High risk | Blinding was considered to be impossible, however, the radiologist in each hospital evaluated the occurrence of VTE with no information on participant allocation |
| Incomplete outcome data (attrition bias) | High risk | Large number of exclusions |
| Selective reporting (reporting bias) | Low risk | Results provided for all outcomes |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: quasi‐RCT | |
| Participants | Country: Turkey | |
| Interventions | Intervention group: LMWH (40 mg/day) combined with IPC | |
| Outcomes | DVT on DUS and clinically evident DVT; and PE by CT scanning | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | Information on randomisation and blinding was obtained from the study authors. No information on start and discontinuation of IPC or LMWH | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quasi‐randomised trial, randomised by the last digit of year of birth |
| Allocation concealment (selection bias) | High risk | Quasi‐randomised trial so predictable |
| Blinding of participants and personnel (performance bias) | High risk | No placebo anticoagulants were used |
| Blinding of outcome assessment (detection bias) | Low risk | The radiologist who performed the US tests was not aware of participant allocation |
| Incomplete outcome data (attrition bias) | Low risk | All study participants were reported in the results section |
| Selective reporting (reporting bias) | Low risk | DVT and PE were the VTE events stated in methodology and results were provided |
| Other bias | Unclear risk | Insufficient details were provided to allow a conclusion to be made |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: China | |
| Interventions | Intervention group: IPC and LMWH nadroparin | |
| Outcomes | Primary: operation time; blood loss during hip replacement; pre‐ and post‐op PLT count, APTT, PT, fibrinogen, total cholesterol; occurrence of DVT after joint replacement | |
| Funding | The Research Project of Health and Family Planning Commission of Guangxi Zhuang Autonomous Region, No. Z2014459 | |
| Declarations of interest | Not reported | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number method |
| Allocation concealment (selection bias) | Unclear risk | No details were provided |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study, without use of placebo |
| Blinding of outcome assessment (detection bias) | Unclear risk | No details were provided |
| Incomplete outcome data (attrition bias) | Low risk | No attrition |
| Selective reporting (reporting bias) | Low risk | Results were provided for all outcomes |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: China | |
| Interventions | Intervention group: IPC and rivaroxaban | |
| Outcomes | Primary outcome: DVT in popliteal or femoral veins, detected on a screening compression DUS, or any symptomatic DVT in the proximal veins, confirmed by imaging, within 21 days of randomisation Secondary outcomes: death, any DVTs, symptomatic DVTs, PE, skin breaks on the legs, falls with injury or fractures, and duration of IPC devices use occurring within 21 days of randomisation, symptomatic VTE, mean intraoperative blood loss, and length of initial hospital stay measured 1 month after randomisation | |
| Funding | National Science Foundation of China (grant number 81371950) | |
| Declarations of interest | None reported | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Consecutively numbered sealed envelopes |
| Allocation concealment (selection bias) | Low risk | Randomisation was performed using consecutively numbered sealed envelopes produced by an independent specialist, which were opened after surgery |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study |
| Blinding of outcome assessment (detection bias) | High risk | Open‐label study, however technician blinded to patients’ allocation performed US |
| Incomplete outcome data (attrition bias) | Low risk | No attrition was reported |
| Selective reporting (reporting bias) | High risk | Results on symptomatic DVT were not reported |
| Other bias | Low risk | None reported |
| Study characteristics | ||
| Methods | Study design: quasi‐RCT | |
| Participants | Country: Russian Federation | |
| Interventions | Intervention group: IPC with elastic stockings and LMWH | |
| Outcomes | Primary outcome: asymptomatic lower‐limb vein thrombosis, as detected by DUS repeated every 3–5 days after surgery until discharge from the hospital or death Secondary outcomes: isolated calf muscle DVT; proximal DVT; symptomatic PE; fatal PE; total VTE events; postoperative mortality; leg skin injury; combination of major and clinically relevant non‐major bleeding; and compliance with IPC), and those obtained at 30th and 180th POD during the outpatient follow‐up (i.e. combination of symptomatic, asymptomatic venous thrombosis of the lower limbs and symptomatic PE; VTE‐related mortality; and non‐VTE‐related mortality | |
| Funding | Research funding from Cardinal Health Ltd | |
| Declarations of interest | KL reports receiving grant support/honoraria from Cardinal Health, Sanofi Aventis, Sigvaris; VicB reports receiving grant support/honoraria from Sigvaris; LL reports receiving grant support/honoraria from Sigvaris. The remaining authors declare no competing financial interests | |
| Notes | DVT occurred in 29 participants of the control group per article supplementary materials. The main article reports on 34 participants developing thrombosis, but this figure included 5 participants with superficial vein thrombosis per supplementary materials | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Based on the number of hospital medical records: those with an even last digit were assigned to the experimental group, and those with an odd last digit were assigned to the control group; if the last digit was zero, the penultimate digit was used |
| Allocation concealment (selection bias) | High risk | Based on the number of hospital medical records: those with an even last digit were assigned to the experimental group, and those with an odd last digit were assigned to the control group; if the last digit was zero, the penultimate digit was used |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study without use of a placebo |
| Blinding of outcome assessment (detection bias) | High risk | Open‐label study. Exception is DVT (Quote: "the blinded expert who performed a duplex ultrasound scan (DUS) had no access to the original medical record or allocation list; he used only individual patients code for identification. Also, to achieve blindness, most duplex scans were performed in a separate room away from the patient’s bed. If it was impossible to transfer a patient, the DUS was performed at the bed, but the IPC device was removed before the blinded expert’s visit.") |
| Incomplete outcome data (attrition bias) | Low risk | No attrition |
| Selective reporting (reporting bias) | Low risk | Results were provided for all outcomes |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Japan | |
| Interventions | Intervention group: IPC and LMWH enoxaparin | |
| Outcomes | Primary endpoint: incidence of VTE (DVT or PE) 28 days after surgery in the efficacy analysis population Secondary endpoint: incidence of all bleeding events, as a composite endpoint that consisted of the incidence of major or minor bleeding events | |
| Funding | None | |
| Declarations of interest | None | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computerised randomisation |
| Allocation concealment (selection bias) | Low risk | Fax to the data centre |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study without use of placebo |
| Blinding of outcome assessment (detection bias) | High risk | Open‐label study without use of placebo |
| Incomplete outcome data (attrition bias) | Low risk | Small number of exclusions |
| Selective reporting (reporting bias) | Low risk | Results provided for all outcomes |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Japan | |
| Interventions | Intervention group: IPC with elastic stockings and LMWH enoxaparin | |
| Outcomes | Primary endpoint: incidence of VTE, including DVT and PE. The risk of adverse events, including hemorrhagic events was also investigated | |
| Funding | Tohoku Surgical Clinical Research Promotion Organization study group | |
| Declarations of interest | None | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Interactive web‐response system |
| Allocation concealment (selection bias) | Low risk | Interactive web‐response system |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study without use of placebo |
| Blinding of outcome assessment (detection bias) | High risk | Open‐label study without use of placebo |
| Incomplete outcome data (attrition bias) | High risk | Large number of exclusions |
| Selective reporting (reporting bias) | Low risk | Results provided for all outcomes |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: USA Exclusion criteria: active treatment for VTE; patients judged by their urologist or preoperative evaluation centre to be unsafe to forgo pharmacologic prophylaxis or systemic anticoagulation postoperatively (whether or not they are on systematic anticoagulation for indications other than VTE); known adverse reactions to heparin (HIT or any allergy); epidural analgesia; spinal anaesthesia; participation in a different study that increases a patient’s risk of VTE | |
| Interventions | Intervention group: IPC and UFH | |
| Outcomes | Primary outcome: incidence of symptomatic VTE Secondary outcome: overall incidence of VTE (asymptomatic or symptomatic) determined from the screening US subcohort Primary safety outcomes: incidence of symptomatic lymphocele, symptomatic haematoma, or bleeding after surgery Secondary outcomes: estimated blood loss from surgery, total surgical drain output after surgery (for participants with surgical drains), complications, and surveillance imaging bias | |
| Funding | James Buchanan Brady Urological Institute Minimally Invasive Urology Fund | |
| Declarations of interest | None | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation schedule |
| Allocation concealment (selection bias) | Low risk | A computer‐generated randomisation schedule was created by the blinded primary study biostatistician (BJT). Treatment groups were assigned in a 1:1 ratio with concealment until individual randomisation was performed on the day of surgery |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study without use of placebo |
| Blinding of outcome assessment (detection bias) | High risk | Open‐label study without use of placebo |
| Incomplete outcome data (attrition bias) | Low risk | No attrition |
| Selective reporting (reporting bias) | Low risk | Results provided for all outcomes |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: UFH (5000 IU twice daily, sc) and SCDs | |
| Outcomes | Symptomatic PE, confirmed by ventilation perfusion scan and/or pulmonary angiography | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | Both prophylactic methods were started immediately after surgery and continued for 4‐5 days or until participants were fully ambulatory | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A table of random numbers was used |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) | High risk | No placebo device was used |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel performing the pulmonary ventilation‐perfusion scans or angiograms were aware of which participants used a compression device |
| Incomplete outcome data (attrition bias) | High risk | A large number of participants were excluded after randomisation |
| Selective reporting (reporting bias) | Low risk | PE was the only VTE event stated in methodology and was reported |
| Other bias | Low risk | Baseline characteristics were comparable |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Japan | |
| Interventions | Intervention group: edoxaban (15 mg or 30 mg once daily) and a foot pump (A‐V Impulse System foot pump) | |
| Outcomes | Symptomatic VTE by postoperative day 28 and asymptomatic DVT on compression US on the POD 10 Bleeding: major bleeding was defined as wound haematoma or haemorrhage occurring at a critical site and bleeding required for > 2 units of RBC concentrates. Minor bleeding was defined as bleeding that did not fulfil the criteria for major bleeding | |
| Funding | National Hospital Organization (NHO), Japan | |
| Declarations of interest | None declared | |
| Notes | Both groups also used bilateral knee‐high antithromboembolic stockings The foot pump was activated in the recovery room and used for 4 days Edoxaban started 12 h postoperatively and was used for a mean of 11.5 days | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated sequence |
| Allocation concealment (selection bias) | High risk | Sealed enveloped contained the randomisation slip, but no statement that these were opaque |
| Blinding of participants and personnel (performance bias) | High risk | No placebo device was used |
| Blinding of outcome assessment (detection bias) | Unclear risk | No information was provided on who performed the US and if that person was blinded to participant allocation |
| Incomplete outcome data (attrition bias) | Low risk | Minimal losses to follow‐up |
| Selective reporting (reporting bias) | Low risk | DVT and PE were VTE events stated in methodology and were reported |
| Other bias | High risk | Study stopped prematurely |
| Study characteristics | ||
| Methods | Study design: quasi‐randomised trial | |
| Participants | Country: China | |
| Interventions | Intervention group: IPC with elastic stockings and LMWH dalteparin | |
| Outcomes | Screening of VTE was performed within 7 days before and 3–5 days after surgery. Initially, colour DUS imaging of lower extremities was performed by an experienced professional using an LEGIQ E9 colour Doppler system with the probe frequency set at 8.4–9 MHz. If VTE was found or suspected, lower limb venography was performed to confirm the presence of DVT, and CTPA was performed to detect if PE was present. | |
| Funding | The Capital Health Research and Development of Special Project (No. 2011‐2003‐03) | |
| Declarations of interest | None | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "A simple randomization method was adopted for this study. Based on the calculated sample size (see below), 660 consecutive random numbers were selected from a random number table, assigned to each patient, and then divided by four. When the remainder was 0, 1, 2, and 3, the patient was allocated to groups A, B, C, and D, respectively. The patients were included sequentially according to the date of surgery." |
| Allocation concealment (selection bias) | High risk | The patients were included sequentially according to the date of surgery |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study without use of placebo |
| Blinding of outcome assessment (detection bias) | High risk | Open‐label study without use of placebo |
| Incomplete outcome data (attrition bias) | Low risk | No attrition |
| Selective reporting (reporting bias) | Low risk | Results provided for all outcomes |
| Other bias | Low risk | None detected |
| Study characteristics | ||
| Methods | Study design: CCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: UFH (5000 IU twice daily, sc) and IPC (SCDs) | |
| Outcomes | Symptomatic DVT or PE | |
| Funding | American Foundation for Urologic Diseases | |
| Declarations of interest | Not reported | |
| Notes | Participants were assigned to heparin and control groups by the primary surgeon Sequential compressive stockings were placed at the time of surgery and left in place for 48 h after surgery for all participants Heparin was started preoperatively and continued for 3 days | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | The type of the study (CCT) makes it high risk for selection bias |
| Allocation concealment (selection bias) | High risk | The type of the study (CCT) makes it high risk for selection bias |
| Blinding of participants and personnel (performance bias) | High risk | No placebo injection for heparin was given |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel performing diagnostic testing were aware of participant allocation |
| Incomplete outcome data (attrition bias) | Low risk | No exclusions or withdrawals were reported |
| Selective reporting (reporting bias) | Low risk | DVT and PE were VTE events stated in methodology and were reported |
| Other bias | Unclear risk | Insufficient details were provided to allow a conclusion to be made |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Germany | |
| Interventions | Intervention group: LMWH enoxaparin (40 mg daily, sc) and pneumatic sequential compression | |
| Outcomes | Symptomatic and asymptomatic DVT (on US) | |
| Funding | Aircast Europa GmbH | |
| Declarations of interest | Not reported | |
| Notes | The calf cuffs were applied to both lower limbs directly after the operation in the recovery room and the system was activated. The use of the IPC was continued until POD 10 whenever the participant was in bed Enoxaparin was started the evening before surgery and continued for 30 days | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) | High risk | A placebo device was not used |
| Blinding of outcome assessment (detection bias) | Unclear risk | Colour DUS was performed by an independent angiologist who was unaware of the patients' participation in the study or of the method of prophylaxis, but only to confirm the findings of compression US, which was not reported to be performed by a blinded or not observer, hence unclear risk of bias |
| Incomplete outcome data (attrition bias) | Low risk | 8 patients who were randomised were subsequently excluded (2 from the LMWH/IPC and 6 from the LMWH/GCS group) for various reasons, but they represent a small percentage of the total participant number, unlikely to change the results and conclusions whatever their outcome might have been |
| Selective reporting (reporting bias) | Low risk | Thromboembolic (VTE) events were stated in methodology to be the outcome measures of the study and they were reported as such |
| Other bias | Low risk | Baseline characteristics were comparable |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Italy | |
| Interventions | Intervention group: UFH + IPC | |
| Outcomes | DVT on venography | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | No information on start and discontinuation of IPC or UFH | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) | High risk | A placebo device was not used |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel performing diagnostic testing were aware of participant allocation |
| Incomplete outcome data (attrition bias) | Low risk | No exclusions or withdrawals were reported |
| Selective reporting (reporting bias) | Low risk | DVT was the only VTE event stated in methodology and was reported |
| Other bias | Unclear risk | Insufficient details were provided to allow a conclusion to be made |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: UFH/aspirin and IPC (foot pump) | |
| Outcomes | Asymptomatic DVT, symptomatic DVT, any DVT, PE | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | The pumps were started in the recovery room immediately after surgery and used until the end of the study, with the exact time not specified Heparin was started 8 h before the operation and after 3 days of use it was replaced with 325 mg aspirin twice daily for an undefined duration | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) | High risk | No placebo for compression, heparin and aspirin |
| Blinding of outcome assessment (detection bias) | Low risk | All duplex results and venograms were read by one of the study authors who was blinded to the prophylactic modality used |
| Incomplete outcome data (attrition bias) | Low risk | No participants were lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | DVT was stated in methodology to be the outcome measure of the study and results were reported |
| Other bias | Low risk | Baseline characteristics were comparable |
| Study characteristics | ||
| Methods | Study design: CCT | |
| Participants | Country: Japan | |
| Interventions | Intervention group: IPC (stopped 24 h after surgery) combined with fondaparinux (sc injections of fondaparinux at 2.5 mg once daily) | |
| Outcomes | Clinically evident DVT and PE Bleeding: major bleeding was defined as bleeding that was fatal, retroperitoneal, intracranial, involving any other critical organ, led to intervention being discontinued, or was associated with a need for transfusion of > 3 units of packed RBC. Other types of bleeding was included and defined as bleeding that did not fulfil the criteria for major bleeding | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | IPC was used for 24 h after surgery, but no information on when it was started Fondaparinux was started 24 h after surgery and was continued until days 5‐7 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | The type of the study (CCT) makes it high risk for selection bias |
| Allocation concealment (selection bias) | High risk | The type of the study (CCT) makes it high risk for selection bias |
| Blinding of participants and personnel (performance bias) | High risk | No placebo for fondaparinux |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel performing diagnostic testing were aware of participant allocation |
| Incomplete outcome data (attrition bias) | Low risk | All enrolled participants had results reported |
| Selective reporting (reporting bias) | Low risk | Thromboembolic events (DVT and PE) were stated in methodology to be the outcome measures of the study and they were reported as such |
| Other bias | Low risk | Baseline characteristics were comparable |
| Study characteristics | ||
| Methods | Study design: randomised, double‐blind, placebo‐controlled, superiority trial | |
| Participants | Country: USA | |
| Interventions | Intervention group: IPC and fondaparinux | |
| Outcomes | VTE (defined as DVT detected by mandatory screening and/or documented symptomatic DVT or PE, or both) and individual components up to day 10. Symptomatic VTE up to day 10 and day 32 Major bleeding (defined as bleeding that was fatal, retroperitoneal, intracranial, or involved any other critical organ, led to intervention being discontinued, or was associated with a bleeding index of ≥ 2.0) detected during the treatment period Death during the treatment period and up to day 32 | |
| Funding | Sanofi‐Synthélabo and GlaxoSmithKline | |
| Declarations of interest | Not reported | |
| Notes | Study medications were packaged in boxes of identical appearance | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Centralised computer‐generated schedule randomisation (1:1 randomisation in blocks of four and stratified by centre) |
| Allocation concealment (selection bias) | Low risk | Centralised computer‐generated schedule randomisation |
| Blinding of participants and personnel (performance bias) | Low risk | Use of placebo injections |
| Blinding of outcome assessment (detection bias) | Low risk | Reports double‐blind (use of placebo injections) but it is unclear if the personnel performing diagnostic testing were aware of participant allocation |
| Incomplete outcome data (attrition bias) | High risk | A large number of exclusions in both study arms, around 35% of the total number of participants, mainly because of lack of mandatory or interpretable venography |
| Selective reporting (reporting bias) | Low risk | DVT and PE were the primary efficacy outcomes and they were reported in the results |
| Other bias | Low risk | Demographic variables and risk factors at baseline, type of anaesthesia, and type and duration of surgery were similar in the 2 groups among both randomised and treated participants (Tables 1 and 2) and among participants analysed for primary efficacy |
| Study characteristics | ||
| Methods | Study design: CCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: IPC and warfarin | |
| Outcomes | DVT on US of the ipsilateral lower external iliac, common femoral, superficial femoral, deep femoral, and popliteal veins | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | No symptomatic VTE was observed 3 participants on warfarin developed bleeding complications The IPC device was applied over the duration of the participant's preoperative and postoperative stay until the time of discharge. Participants sent to a rehabilitation centre were told to continue using the IPC until their final discharge home. Warfarin or aspirin started on the night before surgery but no duration of use was provided | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | The type of the study (CCT) makes it high risk for selection bias |
| Allocation concealment (selection bias) | High risk | The type of the study (CCT) makes it high risk for selection bias |
| Blinding of participants and personnel (performance bias) | High risk | Not a double‐blind study |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel performing diagnostic testing were aware of participant allocation |
| Incomplete outcome data (attrition bias) | Low risk | No exclusions/participants lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | DVT and PE were the main study outcomes and they were reported in the results |
| Other bias | Unclear risk | Insufficient details were provided to allow a conclusion to be made |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: IPC and LMWH enoxaparin | |
| Outcomes | DVT on US before discharge on PODs 3‐5, and 4‐6 weeks after surgery | |
| Funding | Aventis, Bridgewater, NJ, USA and Aircast, Summit, NJ, USA | |
| Declarations of interest | Not reported | |
| Notes | Bleeding complications were documented, no specific bleeding definitions provided Upon their arrival in the recovery room, the participants received a VenaFlow calf compression device that was placed on both of their lower extremities. The compression device was used during each participant's entire hospital stay Enoxaparin was initiated 2 h after epidural catheter removal (approximately 48 h postoperatively). Participants received 30 mg of enoxaparin twice daily until their hospital discharge; upon discharge, their dosage was changed to 40 mg once daily for 3 weeks. Aspirin started on the night of their surgery in the recovery room and was continued for 4 weeks postoperatively | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) | High risk | Not a blinded study |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel performing diagnostic testing were aware of participant allocation |
| Incomplete outcome data (attrition bias) | High risk | A large number of participants were lost to follow‐up, likely to affect outcome results |
| Selective reporting (reporting bias) | Low risk | DVT was the main study outcome and was reported in the results |
| Other bias | Low risk | Baseline characteristics were comparable |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Germany | |
| Interventions | Intervention group: LMWH enoxaparin (40 mg once daily, beginning 24 h prior to the operation) and IPC (foot pump) | |
| Outcomes | DVT on DUS, but also clinically evident DVT and PE | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | Reports none of the participants needed to be operated upon for hemarthrosis, no other details regarding bleeding were provided The A‐V Impulse System foot pump was attached in the recovery room to both feet of the participants only shortly after completion of the operation; participants were free to discontinue its use at will Enoxaparin was started 24 h before surgery, duration was not provided | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) | High risk | A placebo device was not used |
| Blinding of outcome assessment (detection bias) | Low risk | Sonographers were unaware of treatment allocations |
| Incomplete outcome data (attrition bias) | Low risk | No exclusions/participants lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | DVT and PE were VTE events stated in methodology and were reported |
| Other bias | Low risk | There were no baseline imbalances |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: USA | |
| Interventions | Intervention group: IPC, thigh‐high graduated elastic compression stockings, and warfarin (first group); or IPC, thigh‐high graduated elastic compression stockings and aspirin (second group) | |
| Outcomes | Proximal DVT on venography, B‐mode US, or both, on discharge | |
| Funding | None | |
| Declarations of interest | None | |
| Notes | Warfarin dose was 7.5 or 10 mg orally on the evening before the operation, then titrated to maintain the prothrombin time at 1.2 to 1.3 times the control value. Aspirin started the evening before surgery and continued at a dose of 650 mg twice daily. For both agents duration of use was not reported IPC was started in the operating theatre, as soon as the participant was draped and used until discharge Bleeding: 1 participant in each of the 3 groups had a wound haematoma, that required evacuation in the 2 intervention group participants but not in the control group. No specific definition of bleeding provided | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Use of sealed envelope method |
| Allocation concealment (selection bias) | Unclear risk | Does not mention if the sealed envelopes were sequentially numbered and opaque |
| Blinding of participants and personnel (performance bias) | High risk | Not a blinded study |
| Blinding of outcome assessment (detection bias) | Unclear risk | It is unclear if the personnel performing diagnostic testing were aware of participant allocation |
| Incomplete outcome data (attrition bias) | Low risk | No participants were lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | DVT was the main study outcome and was reported in the results |
| Other bias | Low risk | There were no baseline imbalances |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: Japan | |
| Interventions | Intervention groups: | |
| Outcomes | DVT on DUS and also clinically evident DVT and PE Any bleeding, both major or minor. Major bleeding: retro‐peritoneal, intracranial or intraocular, or if associated with either death, transfusion of > 2 units of packed RBC or whole blood (except autologous), a reduction in the level of haemoglobin of > 2 g/dL, or a serious or life‐threatening clinical event requiring medical intervention. Suspected intra‐abdominal or intracranial bleeding was confirmed by US, CT or MRI. Minor bleeding: epistaxis lasting for > 5 min or requiring intervention, ecchymosis or haematoma with a maximum size of > 5 cm, haematuria not associated with trauma from the urinary catheter, GI haemorrhage not related to intubation or the passage of a nasogastric tube, a wound haematoma or haemorrhagic wound complications not associated with major haemorrhage or subconjunctival haemorrhage, requiring cessation of medication | |
| Funding | None | |
| Declarations of interest | None | |
| Notes | The pneumatic devices were initiated in the operating theatre (before surgery for the contralateral leg and just after surgery for the operated leg) and removed on the "second post‐operative day when the day of surgery was defined as post‐operative day 1" Pharmacological prophylaxis was started postoperatively | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) | Low risk | Use of placebo |
| Blinding of outcome assessment (detection bias) | Low risk | Scans were read by experienced radiologist blinded to randomisation |
| Incomplete outcome data (attrition bias) | Low risk | A small percentage of exclusions (5/255, 2%) |
| Selective reporting (reporting bias) | Low risk | DVT and PE were the main study outcomes and they were reported in the results |
| Other bias | Low risk | Baseline characteristics were comparable |
| Study characteristics | ||
| Methods | Study design: RCT | |
| Participants | Country: China | |
| Interventions | Intervention group: IPC with elastic stockings and LMWH enoxaparin | |
| Outcomes | DVT, PE, plasma D‐dimer levels, PLT count, PT, APTT, postoperative lower‐limb pain and swelling, patient satisfaction | |
| Funding | Not reported | |
| Declarations of interest | None | |
| Notes | Although labelled as "double‐blind", this study did not use a placebo device to qualify as such | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details were provided |
| Allocation concealment (selection bias) | Unclear risk | No details were provided |
| Blinding of participants and personnel (performance bias) | High risk | Open‐label study |
| Blinding of outcome assessment (detection bias) | Unclear risk | Unclear if outcome assessors were aware of participant allocation |
| Incomplete outcome data (attrition bias) | Low risk | No attrition |
| Selective reporting (reporting bias) | Low risk | Resuts reported for all outcomes |
| Other bias | Low risk | None detected |
ABI: ankle‐brachial index; APTT: activated partial thromboplastin time; ASA: American Society of Anesthesiology score; BMI: body mass index; CCT: controlled clinical trial; CT: computed tomography; CTPA: computed tomographic pulmonary angiography; CVC: central venous catheter; CVI: chronic venous insufficiency; DIC: disseminated intravascular coagulation; DUS: duplex ultrasound scan; DVT: deep vein thrombosis; ECOG: Eastern Cooperative Oncology Group; GCS: graduated compression stockings; GI: gastrointestinal; h: hours; HIT: heparin‐induced thrombocytopenia; ICU: intensive care unit; IPC: intermittent pneumatic compression; IPG: impedence plethysmography; ITT: intention‐to‐treat; IU: international units;IVC: inferior vena cava; LMWH: low molecular weight heparin; LOS: length of stay; MRI: magnetic resonance imaging; NYHA: New York Hospital Association; PAD: peripheral arterial disease; PE: pulmonary embolism; PESI: pulmonary embolism severity index; POD: postoperative day; PLT: platelet; PT: prothrombin time; RBC: red blood cells; RCT: randomised controlled trial; RP: radical prostatectomy; sc: subcutaneously; SCD: sequential compression device; THA: total hip arthroplasty; THR: total hip replacement; TKA: total knee arthroplasty; TKR: total knee replacement; UFH: unfractionated heparin; US: ultrasonography; VCF: vena cava filter; VTE: venous thromboembolism; WHO: World Health Organization; wk: weeks
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Retrospective case‐control study | |
| Use of combined modalities was not concurrent in the intervention group | |
| Controlled before and after study | |
| Registry study, non‐randomised | |
| Pharmacological prophylaxis was not the same in the 2 study groups | |
| Controlled before and after study | |
| Investigation restricted to intraoperative period up to 10 min after extubation | |
| The control (single modality) group included participants who were allocated to heparin or pneumatic compression | |
| Pharmacological prophylaxis consisted of aspirin, which has limited thromboprophylactic properties | |
| Pharmacological prophylaxis was not the same in the 2 study groups | |
| Only aggregated VTE rates and not separate DVT and PE rates were provided and the study authors did not reply when we requested individual data | |
| Prospective case‐control study | |
| Retrospective study | |
| Pneumatic compression was used only intraoperatively | |
| Pharmacological prophylaxis was not the same in the 2 study groups | |
| Use of enoxaparin was not concurrent in the 2 study groups | |
| Controlled before and after study | |
| Retrospective study | |
| Pharmacological prophylaxis consisted of aspirin, which has limited thromboprophylactic properties | |
| Retrospective case‐control study investigating preoperative anticoagulation in patients on postoperative LMWH and SCDs | |
| Retrospective case‐control study |
DVT: deep vein thrombosis; LMWH: low molecular weight heparin; PE: pulmonary embolism; SCD: sequential compression device; VTE: venous thromboembolism
Characteristics of ongoing studies [ordered by study ID]
| Study name | ChiCTR1800014257 |
| Methods | Multicenter parallel RCT |
| Participants | Women undergoing gynaecologic pelvic surgery |
| Interventions | High‐risk patients: GCS (control group) vs GCS + LMWH Very high‐risk patients: GCS+ IPC (control group) vs GCS + IPC + LMWH |
| Outcomes | Lower extremity venous DUS findings, haematology laboratory measures and CTPA findings |
| Starting date | 1 January 2018 |
| Contact information | Zhengyu Zhang |
| Notes |
| Study name | EUCTR2007‐006206‐24 |
| Methods | IPC with and without early anticoagulant treatment |
| Participants | Patients with acute primary intracerebral haemorrhage |
| Interventions | Blind randomised trial of IPC with and without early anticoagulant treatment |
| Outcomes | Not provided |
| Starting date | 17 December 2008 |
| Contact information | Not provided |
| Notes | Study ended on 30 June 2016, no results are available |
| Study name | NCT00740987 (CIREA 2) |
| Methods | RCT in ICU patients without high risk of bleeding |
| Participants | 621 ICU patients |
| Interventions | Patients were randomised to use IPC or not |
| Outcomes | Primary outcome measures: combined criterion evaluated at day 6 ± 2 days after randomisation: |
| Starting date | October 2007 |
| Contact information | Karine Lacut, MD. CHU Brest France, Univ Brest, EA 3878 |
| Notes | Study completed in January 2015, with no results being presented or published at the time of writing this review |
| Study name | NCT02271399 |
| Methods | Double‐blind, parallel group, RCT |
| Participants | Patients undergoing TKA |
| Interventions | Aspirin and IPC vs rivaroxaban and IPC |
| Outcomes | VTE, bleeding |
| Starting date | October 2014 |
| Contact information | Jin Kyu Lee |
| Notes | Competed on February 2016, no results have been published |
| Study name | NCT03559114 (PROTEST) |
| Methods | Phase III, multi‐centre, double blind, RCT |
| Participants | Patients with traumatic brain Injury |
| Interventions | SCD versus SCS and dalteparin |
| Outcomes | Clinically important VTE, clinically‐important intracranial bleeding progression, objectively confirmed new or progressing intracranial bleeding on radiology, mortality at 7 days, 30 days, 180 days, delayed VTE after day 7, functional neurological outcome at day 30 as measured by Glasgow Outcome Scale Extended, functional neurological outcome at day 180 as measured by Glasgow Outcome Scale Extended, quality of life outcome at 30 days as measured by the EuroQol5D, quality of life outcome at 180 days as measured by the EuroQol5D |
| Starting date | 19 July 2018 |
| Contact information | Farhad Pirouzmand, MD, MSc, FRCSC |
| Notes |
CTPA: computed tomography pulmonary angiogram; CUS: colour ultrasound; DUS: duplex ultrasound; DVT: deep vein thrombosis; GCS: graduated compression stockings; ICU: intensive care unit; IPC: intermittent pneumatic compression; LMWH: low molecular weight heparin; PE: pulmonary embolism; RCT: randomised controlled trial; SCD: sequential compression device; SCS: sequential compression stockings; TKA: total knee arthroplasty; VTE: venous thromboembolism
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Incidence of PE ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 19 | 5462 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.29, 0.91] |
| Analysis 1.1  Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 1: Incidence of PE ‐ orthopaedic and non‐orthopaedic patients | ||||
| 1.1.1 Orthopaedic patients | 3 | 445 | Odds Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.1.2 Non‐orthopaedic patients | 16 | 5017 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.29, 0.91] |
| 1.2 Incidence of PE ‐ foot IPC or other IPC Show forest plot | 19 | 5462 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.29, 0.91] |
| Analysis 1.2  Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 2: Incidence of PE ‐ foot IPC or other IPC | ||||
| 1.2.1 Foot IPC | 1 | 50 | Odds Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.2.2 Other IPC | 18 | 5412 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.29, 0.91] |
| 1.3 Incidence of DVT ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 18 | 5394 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.36, 0.72] |
| Analysis 1.3  Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 3: Incidence of DVT ‐ orthopaedic and non‐orthopaedic patients | ||||
| 1.3.1 Orthopaedic patients | 3 | 445 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.38, 1.69] |
| 1.3.2 Non‐orthopaedic patients | 15 | 4949 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.46 [0.31, 0.68] |
| 1.4 Incidence of symptomatic DVT ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 10 | 4089 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.48 [0.21, 1.10] |
| Analysis 1.4  Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 4: Incidence of symptomatic DVT ‐ orthopaedic and non‐orthopaedic patients | ||||
| 1.4.1 Orthopaedic patients | 1 | 250 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.50 [0.06, 37.33] |
| 1.4.2 Non‐orthopaedic patients | 9 | 3839 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.44 [0.19, 1.04] |
| 1.5 Incidence of DVT ‐ by foot IPC or other IPC Show forest plot | 18 | 5395 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.36, 0.72] |
| Analysis 1.5  Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 5: Incidence of DVT ‐ by foot IPC or other IPC | ||||
| 1.5.1 Foot IPC | 1 | 50 | Odds Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.5.2 Other IPC | 17 | 5345 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.36, 0.72] |
| 1.6 Incidence of bleeding ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 13 | 4634 | Odds Ratio (M‐H, Fixed, 95% CI) | 6.02 [3.88, 9.35] |
| Analysis 1.6  Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 6: Incidence of bleeding ‐ orthopaedic and non‐orthopaedic patients | ||||
| 1.6.1 Orthopaedic patients | 2 | 400 | Odds Ratio (M‐H, Fixed, 95% CI) | 2.79 [0.77, 10.18] |
| 1.6.2 Non‐orthopaedic patients | 11 | 4234 | Odds Ratio (M‐H, Fixed, 95% CI) | 6.61 [4.14, 10.56] |
| 1.7 Incidence of major bleeding ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 12 | 4133 | Odds Ratio (M‐H, Fixed, 95% CI) | 5.77 [2.81, 11.83] |
| Analysis 1.7  Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 7: Incidence of major bleeding ‐ orthopaedic and non‐orthopaedic patients | ||||
| 1.7.1 Orthopaedic patients | 2 | 400 | Odds Ratio (M‐H, Fixed, 95% CI) | 3.35 [0.13, 83.62] |
| 1.7.2 Non‐orthopaedic patients | 10 | 3733 | Odds Ratio (M‐H, Fixed, 95% CI) | 5.91 [2.83, 12.36] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Incidence of PE ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 15 | 6737 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.46 [0.30, 0.71] |
| Analysis 2.1  Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 1: Incidence of PE ‐ orthopaedic and non‐orthopaedic patients | ||||
| 2.1.1 Orthopaedic patients | 8 | 1202 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.08, 4.49] |
| 2.1.2 Non‐orthopaedic patients | 7 | 5535 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.46 [0.29, 0.71] |
| 2.2 Incidence of PE ‐ foot IPC or other IPC Show forest plot | 15 | 6737 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.46 [0.30, 0.71] |
| Analysis 2.2  Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 2: Incidence of PE ‐ foot IPC or other IPC | ||||
| 2.2.1 Foot IPC | 4 | 324 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.32 [0.01, 8.25] |
| 2.2.2 Other IPC | 11 | 6413 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.47 [0.30, 0.72] |
| 2.3 Incidence of DVT ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 17 | 6151 | Odds Ratio (M‐H, Random, 95% CI) | 0.38 [0.21, 0.70] |
| Analysis 2.3  Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 3: Incidence of DVT ‐ orthopaedic and non‐orthopaedic patients | ||||
| 2.3.1 Orthopaedic patients | 10 | 3075 | Odds Ratio (M‐H, Random, 95% CI) | 0.34 [0.18, 0.68] |
| 2.3.2 Non‐orthopaedic patients | 7 | 3076 | Odds Ratio (M‐H, Random, 95% CI) | 0.46 [0.13, 1.61] |
| 2.4 Incidence of symptomatic DVT ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 7 | 3032 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.34, 2.01] |
| Analysis 2.4  Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 4: Incidence of symptomatic DVT ‐ orthopaedic and non‐orthopaedic patients | ||||
| 2.4.1 Orthopaedic patients | 3 | 477 | Odds Ratio (M‐H, Fixed, 95% CI) | 2.09 [0.38, 11.50] |
| 2.4.2 Non‐orthopaedic patients | 4 | 2555 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.55 [0.18, 1.66] |
| 2.5 Incidence of DVT ‐ foot IPC or other IPC Show forest plot | 16 | 4148 | Odds Ratio (M‐H, Random, 95% CI) | 0.34 [0.18, 0.63] |
| Analysis 2.5  Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 5: Incidence of DVT ‐ foot IPC or other IPC | ||||
| 2.5.1 Foot IPC | 4 | 324 | Odds Ratio (M‐H, Random, 95% CI) | 0.40 [0.05, 3.47] |
| 2.5.2 Other IPC | 12 | 3824 | Odds Ratio (M‐H, Random, 95% CI) | 0.31 [0.17, 0.54] |
| 2.6 Incidence of bleeding ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 6 | 1314 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.87 [0.56, 1.35] |
| Analysis 2.6  Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 6: Incidence of bleeding ‐ orthopaedic and non‐orthopaedic patients | ||||
| 2.6.1 Orthopaedic patients | 3 | 550 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.64 [0.20, 2.07] |
| 2.6.2 Non‐orthopaedic patients | 3 | 764 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.91 [0.57, 1.47] |
| 2.7 Incidence of major bleeding ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 5 | 908 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.21 [0.35, 4.18] |
| Analysis 2.7  Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 7: Incidence of major bleeding ‐ orthopaedic and non‐orthopaedic patients | ||||
| 2.7.1 Orthopaedic patients | 3 | 551 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.07 [0.21, 5.54] |
| 2.7.2 Non‐orthopaedic patients | 2 | 357 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.42 [0.21, 9.49] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Incidence of PE Show forest plot | 3 | 605 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.03, 3.19] |
| Analysis 3.1  Comparison 3: IPC plus pharmacological prophylaxis versus IPC plus aspirin, Outcome 1: Incidence of PE | ||||
| 3.2 Incidence of DVT Show forest plot | 3 | 605 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.48, 1.42] |
| Analysis 3.2  Comparison 3: IPC plus pharmacological prophylaxis versus IPC plus aspirin, Outcome 2: Incidence of DVT | ||||
| 3.3 Incidence of symptomatic DVT Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Analysis 3.3  Comparison 3: IPC plus pharmacological prophylaxis versus IPC plus aspirin, Outcome 3: Incidence of symptomatic DVT | ||||
| 3.4 Incidence of bleeding Show forest plot | 3 | 616 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.23 [0.27, 5.53] |
| Analysis 3.4  Comparison 3: IPC plus pharmacological prophylaxis versus IPC plus aspirin, Outcome 4: Incidence of bleeding | ||||
| 3.5 Incidence of major bleeding Show forest plot | 3 | 616 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.15, 4.17] |
| Analysis 3.5  Comparison 3: IPC plus pharmacological prophylaxis versus IPC plus aspirin, Outcome 5: Incidence of major bleeding | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Incidence of PE Show forest plot | 13 | 4159 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.54 [0.28, 1.07] |
| Analysis 4.1  Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 1: Incidence of PE | ||||
| 4.2 Incidence of DVT Show forest plot | 13 | 4159 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.53 [0.36, 0.77] |
| Analysis 4.2  Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 2: Incidence of DVT | ||||
| 4.3 Incidence of symptomatic DVT Show forest plot | 7 | 3064 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.21 [0.15, 9.63] |
| Analysis 4.3  Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 3: Incidence of symptomatic DVT | ||||
| 4.4 Incidence of DVT by foot IPC or other IPC Show forest plot | 17 | 5085 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.52 [0.36, 0.74] |
| Analysis 4.4  Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 4: Incidence of DVT by foot IPC or other IPC | ||||
| 4.4.1 Foot IPC | 1 | 50 | Odds Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 4.4.2 Other IPC | 16 | 5035 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.52 [0.36, 0.74] |
| 4.5 Incidence of bleeding Show forest plot | 10 | 4120 | Odds Ratio (M‐H, Fixed, 95% CI) | 5.45 [3.38, 8.80] |
| Analysis 4.5  Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 5: Incidence of bleeding | ||||
| 4.6 Incidence of major bleeding Show forest plot | 9 | 3619 | Odds Ratio (M‐H, Fixed, 95% CI) | 5.90 [2.82, 12.33] |
| Analysis 4.6  Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 6: Incidence of major bleeding | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 5.1 Incidence of PE Show forest plot | 11 | 5758 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.45 [0.29, 0.70] |
| Analysis 5.1  Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 1: Incidence of PE | ||||
| 5.2 Incidence of DVT Show forest plot | 13 | 5172 | Odds Ratio (M‐H, Random, 95% CI) | 0.44 [0.22, 0.87] |
| Analysis 5.2  Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 2: Incidence of DVT | ||||
| 5.3 Incidence of symptomatic DVT Show forest plot | 5 | 2312 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.02 [0.29, 3.54] |
| Analysis 5.3  Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 3: Incidence of symptomatic DVT | ||||
| 5.4 Incidence of DVT by foot IPC or other IPC Show forest plot | 15 | 5431 | Odds Ratio (M‐H, Random, 95% CI) | 0.42 [0.23, 0.80] |
| Analysis 5.4  Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 4: Incidence of DVT by foot IPC or other IPC | ||||
| 5.4.1 Foot IPC | 4 | 324 | Odds Ratio (M‐H, Random, 95% CI) | 0.40 [0.05, 3.47] |
| 5.4.2 Other IPC | 11 | 5107 | Odds Ratio (M‐H, Random, 95% CI) | 0.40 [0.20, 0.81] |
| 5.5 Incidence of bleeding Show forest plot | 4 | 594 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.30, 2.14] |
| Analysis 5.5  Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 5: Incidence of bleeding | ||||
| 5.6 Incidence of major bleeding Show forest plot | 4 | 595 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.21 [0.35, 4.18] |
| Analysis 5.6  Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 6: Incidence of major bleeding | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 6.1 Incidence of PE Show forest plot | 2 | 405 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.03, 3.19] |
| Analysis 6.1  Comparison 6: IPC plus pharmacological prophylaxis versus IPC plus aspirin ‐ RCTs only, Outcome 1: Incidence of PE | ||||
| 6.2 Incidence of DVT Show forest plot | 2 | 405 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.79 [0.44, 1.39] |
| Analysis 6.2  Comparison 6: IPC plus pharmacological prophylaxis versus IPC plus aspirin ‐ RCTs only, Outcome 2: Incidence of DVT | ||||
Study flow diagram
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 1: Incidence of PE ‐ orthopaedic and non‐orthopaedic patients
Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 2: Incidence of PE ‐ foot IPC or other IPC
Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 3: Incidence of DVT ‐ orthopaedic and non‐orthopaedic patients
Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 4: Incidence of symptomatic DVT ‐ orthopaedic and non‐orthopaedic patients
Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 5: Incidence of DVT ‐ by foot IPC or other IPC
Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 6: Incidence of bleeding ‐ orthopaedic and non‐orthopaedic patients
Comparison 1: IPC plus pharmacological prophylaxis versus IPC alone, Outcome 7: Incidence of major bleeding ‐ orthopaedic and non‐orthopaedic patients
Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 1: Incidence of PE ‐ orthopaedic and non‐orthopaedic patients
Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 2: Incidence of PE ‐ foot IPC or other IPC
Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 3: Incidence of DVT ‐ orthopaedic and non‐orthopaedic patients
Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 4: Incidence of symptomatic DVT ‐ orthopaedic and non‐orthopaedic patients
Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 5: Incidence of DVT ‐ foot IPC or other IPC
Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 6: Incidence of bleeding ‐ orthopaedic and non‐orthopaedic patients
Comparison 2: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone, Outcome 7: Incidence of major bleeding ‐ orthopaedic and non‐orthopaedic patients
Comparison 3: IPC plus pharmacological prophylaxis versus IPC plus aspirin, Outcome 1: Incidence of PE
Comparison 3: IPC plus pharmacological prophylaxis versus IPC plus aspirin, Outcome 2: Incidence of DVT
Comparison 3: IPC plus pharmacological prophylaxis versus IPC plus aspirin, Outcome 3: Incidence of symptomatic DVT
Comparison 3: IPC plus pharmacological prophylaxis versus IPC plus aspirin, Outcome 4: Incidence of bleeding
Comparison 3: IPC plus pharmacological prophylaxis versus IPC plus aspirin, Outcome 5: Incidence of major bleeding
Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 1: Incidence of PE
Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 2: Incidence of DVT
Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 3: Incidence of symptomatic DVT
Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 4: Incidence of DVT by foot IPC or other IPC
Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 5: Incidence of bleeding
Comparison 4: IPC plus pharmacological prophylaxis versus IPC alone ‐ RCTs only, Outcome 6: Incidence of major bleeding
Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 1: Incidence of PE
Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 2: Incidence of DVT
Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 3: Incidence of symptomatic DVT
Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 4: Incidence of DVT by foot IPC or other IPC
Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 5: Incidence of bleeding
Comparison 5: IPC plus pharmacological prophylaxis versus pharmacological prophylaxis alone ‐ RCTs only, Outcome 6: Incidence of major bleeding
Comparison 6: IPC plus pharmacological prophylaxis versus IPC plus aspirin ‐ RCTs only, Outcome 1: Incidence of PE
Comparison 6: IPC plus pharmacological prophylaxis versus IPC plus aspirin ‐ RCTs only, Outcome 2: Incidence of DVT
| Does combined intermittent pneumatic compression (IPC) plus pharmacological prophylaxis increase prevention of venous thromboembolism compared with IPC alone? | ||||||
| Patient or population: people undergoing surgery or at risk of developing VTE due to surgery, trauma or ICU stay Settings: hospital Intervention: combined modalities ‐ IPC plus pharmacological prophylaxis Comparison: IPC alone | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | No of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with IPC alone | Risk with combined modalities | |||||
| Incidence of PEa (early postoperative period) | 16 per 1000 | 7 per 1000 (4 to 12) | OR 0.51 (0.29 to 0.91) | 5462 (19) | ⊕⊕⊝⊝ |
|
| Incidence of DVTc (early postoperative period) | 38 per 1000 | 20 per 1000 (14 to 28) | OR 0.51 (0.36 to 0.72) | 5394 (18) | ⊕⊕⊝⊝ |
|
| Incidence of bleedingd (early postoperative period) | 10 per 1000 | 55 per 1000 (36 to 83) | OR 6.02 (3.88 to 9.35) | 4634 (13) | ⊕⊝⊝⊝ |
|
| Incidence of major bleedingf (early postoperative period) | 3 per 1000 | 19 per 1000 (10 to 39) | OR 5.77 (2.81 to 11.83) | 4133 (12) | ⊕⊝⊝⊝ Very lowe |
|
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI) | ||||||
| GRADE Working Group grades of evidence | ||||||
| aPulmonary embolism assessed by pulmonary angiography or scintigraphy, computed tomography (CT), angiography, or autopsy. | ||||||
| Does combined intermittent pneumatic compression (IPC) plus pharmacological prophylaxis increase prevention of venous thromboembolism compared with pharmacological prophylaxis alone? | ||||||
| Patient or population: people undergoing surgery or at risk of developing VTE because of surgery, trauma or ICU stay Settings: hospital Intervention: combined modalities ‐ IPC plus pharmacological prophylaxis Comparison: pharmacological prophylaxis alone | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect | No of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with pharmacological prophylaxis alone
| Risk with combined modalities | |||||
| Incidence of PEa (early postoperative period) | 18 per 1000 | 9 per 1000 (6 to 13) | OR 0.46 (0.30 to 0.71) | 6737 (15) | ⊕⊕⊝⊝ |
|
| Incidence of DVTc (early postoperative period) | 93 per 1000 | 37 per 1000 (21 to 67) | OR 0.38 (0.21 to 0.70) | 6151 (17) | ⊕⊕⊕⊕ |
|
| Incidence of bleedinge (early postoperative period) | 74 per 1000 | 65 per 1000 (43 to 98) | OR 0.87 (0.56 to 1.35 | 1314 (6) | ⊕⊝⊝⊝ Very lowf |
|
| Incidence of major bleedingg (early postoperative period) | 11 per 1000 | 13 per 1000 (4 to 44) | OR 1.21 (0.35 to 4.18) | 908 (5) | ⊕⊝⊝⊝ Very lowf |
|
| * The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI) | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. | ||||||
| aPulmonary embolism assessed by pulmonary angiography or scintigraphy, computed tomography (CT), angiography, single photon emission CT (SPECT) or autopsy. | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Incidence of PE ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 19 | 5462 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.29, 0.91] |
| 1.1.1 Orthopaedic patients | 3 | 445 | Odds Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.1.2 Non‐orthopaedic patients | 16 | 5017 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.29, 0.91] |
| 1.2 Incidence of PE ‐ foot IPC or other IPC Show forest plot | 19 | 5462 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.29, 0.91] |
| 1.2.1 Foot IPC | 1 | 50 | Odds Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.2.2 Other IPC | 18 | 5412 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.29, 0.91] |
| 1.3 Incidence of DVT ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 18 | 5394 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.36, 0.72] |
| 1.3.1 Orthopaedic patients | 3 | 445 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.38, 1.69] |
| 1.3.2 Non‐orthopaedic patients | 15 | 4949 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.46 [0.31, 0.68] |
| 1.4 Incidence of symptomatic DVT ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 10 | 4089 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.48 [0.21, 1.10] |
| 1.4.1 Orthopaedic patients | 1 | 250 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.50 [0.06, 37.33] |
| 1.4.2 Non‐orthopaedic patients | 9 | 3839 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.44 [0.19, 1.04] |
| 1.5 Incidence of DVT ‐ by foot IPC or other IPC Show forest plot | 18 | 5395 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.36, 0.72] |
| 1.5.1 Foot IPC | 1 | 50 | Odds Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.5.2 Other IPC | 17 | 5345 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.51 [0.36, 0.72] |
| 1.6 Incidence of bleeding ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 13 | 4634 | Odds Ratio (M‐H, Fixed, 95% CI) | 6.02 [3.88, 9.35] |
| 1.6.1 Orthopaedic patients | 2 | 400 | Odds Ratio (M‐H, Fixed, 95% CI) | 2.79 [0.77, 10.18] |
| 1.6.2 Non‐orthopaedic patients | 11 | 4234 | Odds Ratio (M‐H, Fixed, 95% CI) | 6.61 [4.14, 10.56] |
| 1.7 Incidence of major bleeding ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 12 | 4133 | Odds Ratio (M‐H, Fixed, 95% CI) | 5.77 [2.81, 11.83] |
| 1.7.1 Orthopaedic patients | 2 | 400 | Odds Ratio (M‐H, Fixed, 95% CI) | 3.35 [0.13, 83.62] |
| 1.7.2 Non‐orthopaedic patients | 10 | 3733 | Odds Ratio (M‐H, Fixed, 95% CI) | 5.91 [2.83, 12.36] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Incidence of PE ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 15 | 6737 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.46 [0.30, 0.71] |
| 2.1.1 Orthopaedic patients | 8 | 1202 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.58 [0.08, 4.49] |
| 2.1.2 Non‐orthopaedic patients | 7 | 5535 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.46 [0.29, 0.71] |
| 2.2 Incidence of PE ‐ foot IPC or other IPC Show forest plot | 15 | 6737 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.46 [0.30, 0.71] |
| 2.2.1 Foot IPC | 4 | 324 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.32 [0.01, 8.25] |
| 2.2.2 Other IPC | 11 | 6413 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.47 [0.30, 0.72] |
| 2.3 Incidence of DVT ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 17 | 6151 | Odds Ratio (M‐H, Random, 95% CI) | 0.38 [0.21, 0.70] |
| 2.3.1 Orthopaedic patients | 10 | 3075 | Odds Ratio (M‐H, Random, 95% CI) | 0.34 [0.18, 0.68] |
| 2.3.2 Non‐orthopaedic patients | 7 | 3076 | Odds Ratio (M‐H, Random, 95% CI) | 0.46 [0.13, 1.61] |
| 2.4 Incidence of symptomatic DVT ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 7 | 3032 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.34, 2.01] |
| 2.4.1 Orthopaedic patients | 3 | 477 | Odds Ratio (M‐H, Fixed, 95% CI) | 2.09 [0.38, 11.50] |
| 2.4.2 Non‐orthopaedic patients | 4 | 2555 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.55 [0.18, 1.66] |
| 2.5 Incidence of DVT ‐ foot IPC or other IPC Show forest plot | 16 | 4148 | Odds Ratio (M‐H, Random, 95% CI) | 0.34 [0.18, 0.63] |
| 2.5.1 Foot IPC | 4 | 324 | Odds Ratio (M‐H, Random, 95% CI) | 0.40 [0.05, 3.47] |
| 2.5.2 Other IPC | 12 | 3824 | Odds Ratio (M‐H, Random, 95% CI) | 0.31 [0.17, 0.54] |
| 2.6 Incidence of bleeding ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 6 | 1314 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.87 [0.56, 1.35] |
| 2.6.1 Orthopaedic patients | 3 | 550 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.64 [0.20, 2.07] |
| 2.6.2 Non‐orthopaedic patients | 3 | 764 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.91 [0.57, 1.47] |
| 2.7 Incidence of major bleeding ‐ orthopaedic and non‐orthopaedic patients Show forest plot | 5 | 908 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.21 [0.35, 4.18] |
| 2.7.1 Orthopaedic patients | 3 | 551 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.07 [0.21, 5.54] |
| 2.7.2 Non‐orthopaedic patients | 2 | 357 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.42 [0.21, 9.49] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Incidence of PE Show forest plot | 3 | 605 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.03, 3.19] |
| 3.2 Incidence of DVT Show forest plot | 3 | 605 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.48, 1.42] |
| 3.3 Incidence of symptomatic DVT Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 3.4 Incidence of bleeding Show forest plot | 3 | 616 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.23 [0.27, 5.53] |
| 3.5 Incidence of major bleeding Show forest plot | 3 | 616 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.15, 4.17] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Incidence of PE Show forest plot | 13 | 4159 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.54 [0.28, 1.07] |
| 4.2 Incidence of DVT Show forest plot | 13 | 4159 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.53 [0.36, 0.77] |
| 4.3 Incidence of symptomatic DVT Show forest plot | 7 | 3064 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.21 [0.15, 9.63] |
| 4.4 Incidence of DVT by foot IPC or other IPC Show forest plot | 17 | 5085 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.52 [0.36, 0.74] |
| 4.4.1 Foot IPC | 1 | 50 | Odds Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 4.4.2 Other IPC | 16 | 5035 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.52 [0.36, 0.74] |
| 4.5 Incidence of bleeding Show forest plot | 10 | 4120 | Odds Ratio (M‐H, Fixed, 95% CI) | 5.45 [3.38, 8.80] |
| 4.6 Incidence of major bleeding Show forest plot | 9 | 3619 | Odds Ratio (M‐H, Fixed, 95% CI) | 5.90 [2.82, 12.33] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 5.1 Incidence of PE Show forest plot | 11 | 5758 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.45 [0.29, 0.70] |
| 5.2 Incidence of DVT Show forest plot | 13 | 5172 | Odds Ratio (M‐H, Random, 95% CI) | 0.44 [0.22, 0.87] |
| 5.3 Incidence of symptomatic DVT Show forest plot | 5 | 2312 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.02 [0.29, 3.54] |
| 5.4 Incidence of DVT by foot IPC or other IPC Show forest plot | 15 | 5431 | Odds Ratio (M‐H, Random, 95% CI) | 0.42 [0.23, 0.80] |
| 5.4.1 Foot IPC | 4 | 324 | Odds Ratio (M‐H, Random, 95% CI) | 0.40 [0.05, 3.47] |
| 5.4.2 Other IPC | 11 | 5107 | Odds Ratio (M‐H, Random, 95% CI) | 0.40 [0.20, 0.81] |
| 5.5 Incidence of bleeding Show forest plot | 4 | 594 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.30, 2.14] |
| 5.6 Incidence of major bleeding Show forest plot | 4 | 595 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.21 [0.35, 4.18] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 6.1 Incidence of PE Show forest plot | 2 | 405 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.03, 3.19] |
| 6.2 Incidence of DVT Show forest plot | 2 | 405 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.79 [0.44, 1.39] |
