Methods

Randomised controlled trial.

Participants

Male and female patients.
Over 18 years.
PEG tube inserted for CVA (n= 38) CNS disorders (n= 20), oropharyngeal cancer (n= 18) and miscellaneous (n= 26) (Taken from Table 1 ‐ 102 patients evaluable on a per protocol analysis).
Excluded if no consent or suspected/confirmed allergy to antibiotic used.
Total number of patients randomised; n = 141.

Interventions

'Pull' technique
Group 1: cefuroxime 750 mg IV 30 min prior to PEG (n = 50);
Group 2: saline placebo IV 30 min prior to PEG (n = 51);
Group 3: receiving antibiotics before and during the study (n = 40).

Outcomes

Peristomal infection.
Complications.

Notes

Group 3 excluded from analysis as not randomised.Used Jain et al criteria for wound assessment.
Country of origin: Wales.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Predetermined computer‐generated randomisation scheme.

Allocation concealment (selection bias)

Unclear risk

Review authors unable to contact study authors for clarification.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Patients received intravenous antibiotics or saline.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Procedure by doctor or nurse not involved in the study.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Blinded to treatment group.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Unclear risk

8 (5.6%) of 141 patients excluded because of incomplete data.

Comment: A 5.6% drop out rate makes the study at unclear risk of attrition bias. However the study reports 133 patients "were analysable on an intention to treat analysis".

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Balanced for gender, age, reason for PEG, underlying conditions.

Timing of outcome assessment similar in all groups?

Low risk

In all groups outcomes were assessed immediately after procedure plus three, five and seven days.

Methods

Randomised controlled trial.

Participants

Consecutive male and female patients.

PEG tube inserted for oropharyngeal cancer (n= 56), neurological (n= 32) and other (n= 12).
Inclusion and exclusion criteria not stated.
Total number of patients randomised; n = 100.

Interventions

'Pull' and 'push' techniques.
Group 1: Pull, augmentin 1.2 g IV 3 doses given, 1st dose 30 min prior to procedure two doses administered over 24 hours (n = 37);
Group 2: pull, no placebo, no antibiotic (n = 34);
Group 3: push, no placebo, no antibiotic (n = 29).

Outcomes

Peristomal infection.
Major and minor complications.
Comparison between push and pull technique.

Notes

Criteria for wound assessment: minor infection present if redness with or without purulent discharge, major infection judged by physician as those requiring antibiotics.
Country of origin: Netherlands.
No power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated.

Allocation concealment (selection bias)

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding patient

Unclear risk

Not stated; no placebo given.

Blinding (performance bias and detection bias)
Blinding care provider

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Unclear risk

Not stated.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

PEG placement failed in four patients (4%).

Selective reporting (reporting bias)

Low risk

All prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

All groups were balanced for age, reason for PEG, underlying conditions.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes assessed in all groups twice weekly for one month.

Methods

Randomised controlled trial

Participants

Male and female patients.

PEG tube inserted for ear, nose or throat cancer (127), neurological disease (42), oesophageal cancer (n= 30), stroke (n= 11), dementia (n= 1), gastric cancer (n= 1), and other (n= 22).

Included if able to consent to participation in the study after receiving oral and written information
or did not meet exclusion criteria and no contraindications for PEG.

Excluded if ongoing antibiotic treatment, illness too severe to allow the patient to participate, allergy to any of the antibiotic alternatives.

Total number of patients randomised; n = 234

Interventions

Pull technique.
Group 1: Co‐trimoxazole (800mg sulfamethoxazole &160mg trimethoprim) in 20ml deposited in the PEG immediately after insertion (n=116).
Group 2: Cefuroxime 1.5g IV given 1 hour before PEG insertion (n= 118).

Outcomes

Primary outcome ‐ wound infection

Clinically evident peristomal infection at follow up appointment infection within 7‐ 14 days after insertion of the PEG catheter.
Secondary outcomes ‐ Positive bacterial culture or blood biochemistry.

Notes

Criteria for wound assessment: a clinically identifiable wound infection, as judged by a red zone around the catheter or occurrence of pus, subcutaneous swelling, and pain on palpation in the area around the catheter.
Secondary outcomes objective signs of infection, including a positive bacterial culture, high levels of highly sensitive C reactive protein, and a high white blood cell count.
Country of origin: Sweden.
Power calculation performed for non‐inferiority.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"The randomisation process was conducted by personnel at a hospital department not engaged in the care of the included patients"
"Personnel were contacted by telephone and on request opened a closed envelope, taken from a pre‐prepared block (50 envelopes in each block) of equally distributed and mixed envelopes, containing a randomisation sheet with information on the drug to be used"

Allocation concealment (selection bias)

Low risk

"The randomisation process was conducted by personnel at a hospital department not engaged in the care of the included patients"
"Personnel were contacted by telephone and on request opened a closed envelope, taken from a pre‐prepared block (50 envelopes in each block) of equally distributed and mixed envelopes, containing a randomisation sheet with information on the drug to be used"

Blinding (performance bias and detection bias)
Blinding patient

Low risk

"the blinding of the patients was accomplished by using intravenous fluid and manipulating the newly inserted PEG catheter in all patients. This sham manoeuvre was facilitated by the use of sedation"

Blinding (performance bias and detection bias)
Blinding care provider

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

"The nurses who evaluated the patients at follow‐up visit were not involved in insertion of the PEG catheter, including the administration of antibiotics"

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

High risk

Out of 34 dropouts (14.5%) or withdrawals, a total of twelve participants in each group did not undergo PEG placement for anatomical reasons. Other attrition included five deaths, one patient pulled out PEG, three lost to follow‐up and one received co‐trimoxazole after being randomised to cefuroxime.

Comment: 15% drop out rate makes the study at high risk of attrition bias, but ITT analysis undertaken.

Selective reporting (reporting bias)

Low risk

All prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for age,smoking, diabetes, indications for PEG.Slight gender imbalance 42 females in group 1 versus 31 females in group 2.

Timing of outcome assessment similar in all groups?

Low risk

7‐14 days for both groups.

Methods

Randomised controlled trial.

Participants

Male and female patients aged over 18 years requiring enteral feeding via PEG tube > six weeks.

PEG tube inserted for neurological disease (n= 145), tumour (n= 63) and other (n= 8). (Taken from Table 1 ‐ 216 patients evaluable as 21 dropouts).
Excluded if signs of infection, peritonitis ascites, peritoneal malignancy, prior gastric/bowel disease, granulocytopenia, previous radio/chemotherapy, antibiotic treatment within previous 72 h, clotting/platelet disorders, sensitivity to ceftriaxone.
Total number of patients randomised; n = 237.

Interventions

'Pull' technique:
Group 1: ceftriaxone 1 g IV 30 min prior to PEG (n = 106);
Group 2: no placebo, no antibiotic (n = 110).

Numbers originally randomised into groups not given in trial report.

Outcomes

Peristomal infection.
Mortality.
Cost of antibiotic therapy.
Post‐intervention antibiotic therapy.

Notes

Used modified Jain et al criteria for wound assessment.
Data from four previous studies incorporated into this study.
Data from previous study (1999a), sponsored by Hoffman La Roche, incorporated into this study.
Conducted in 12 secondary and tertiary medical centres.
Country of origin: Germany.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomised in blocks of four using Rancode 3.1.

Allocation concealment (selection bias)

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding patient

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding care provider

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Unclear risk

'Study monitors' involved but specific role not stated.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

21 drop outs (8.9%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes addressed.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups balanced for gender, age, reasons for PEG tube, BMI,indications for PEG, underlying conditions.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed at one, two, four and ten days (mean 8.7).

Methods

Randomised controlled trial.

Participants

Male and female patients with proportionately more males (n = 243) than females (n = 93).

PEG tube inserted for malignant disease (n= 210), neurological disorders (n= 97). (Taken from Table 1 ‐ 307 patients evaluable as 40 dropouts).

Included if had functional resorption and digestive capacity with temporary, or permanent, dysphagia.
Excluded if severe clotting or wound healing disorder, pronounced immune deficiency, paralytic ileus, Billroth II procedure, peritonitis, ascites, sensitive to antibiotics used.
Total number of patients randomised; n = 347.

Interventions

Modified 'pull' technique.
Group 1: cefotaxime 2 g by infusion 30 min prior to PEG (n = 101);
Group 2: piperacillin 2 g + 0.5 g tazobactam by infusion (n = 100);
Group 3: no placebo, no antibiotic (n = 106).
Infusion given over 20 min.

Numbers originally randomised into groups not given in trial report

Outcomes

Peristomal infection.
Peritonitis.
Mortality.

Notes

Used Jain et al and Shapiro et al criteria for wound assessment.
Included data from a previous study.
Country of origin: Germany.
No power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated.

Allocation concealment (selection bias)

High risk

Randomly assigned to group after consent taken, and at least one day before procedure.

Blinding (performance bias and detection bias)
Blinding patient

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding care provider

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Unclear risk

Not stated.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

40 drop outs (11.5%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

All groups were balanced for age, gender, weight, Karnofksy index, reasons for PEG.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in all groups were assessed daily for seven days. Those discharged were assessed over the telephone or via the outpatient department, but the group was not specified.

Methods

Randomised controlled trial.

Participants

Male and female patients (distribution not stated) who had given consent.

PEG tube inserted for CVA (n= 53), oropharyngeal cancer (n= 27), CNS trauma (n= 8), CNS infection (n= 3), CNS degenerative disease (n= 10) and miscellaneous (n= 6).
Excluded if: allergic to cefazolin, refused signed consent, technical reasons for PEG placement.
Total number of patients randomised; n = 107.

Interventions

Technique not stated, but presumed to be 'pull' as the authors state 'the feeding tube traverses the mouth and pharynx'.
Group 1: receiving antibiotics before and during the study and were randomly assigned to:
Group 1 a: cefazolin 1 g IV 30 min prior to PEG (n = 25);
Group 1 b: saline placebo IV 30 min prior to PEG (n = 27);

Group 2 not receiving antibiotics were randomly assigned to:
Group 2 a: cefazolin 1 g IV 30 min prior to PEG (n = 27);
Group 2 b: saline placebo IV 30 min prior to PEG (n = 28).

Outcomes

Peristomal infection.

Notes

Criteria for wound assessment scoring devised by Jain et al which used indicators previously used by Shapiro et al (1982).
Group 1 excluded from grouped analysis.
Country of origin: USA.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation schedule generated by Hewlitt‐Packard HP‐67 pocket calculator.

Allocation concealment (selection bias)

Low risk

One author (KPC) was responsible for (and the only one aware of) assignment and did not evaluate the wounds.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Outcomes assessed by team members blind to placebo allocation.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

No drop outs.

Selective reporting (reporting bias)

Low risk

Prespecified outcomes addressed.

Baseline imbalance? (Was the study free of baseline imbalance?)

Unclear risk

All groups were balanced for gender, underlying conditions, reasons for PEG. In group 1 the mean age was slightly but significantly less than that of patients who did not receive prophylaxis.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in all groups were assessed daily for seven days.

Methods

Randomised controlled trial.

Participants

All male patients with dysphagia, consent, and functionally‐intact gastrointestinal tract.

PEG tube inserted for underlying malignancy (n= 18) and neurological (n= 15). (Taken from Table 4 ‐ 33 patients evaluable as 4 dropouts).
Excluded if had gastric ulcer/cancer, active infection requiring antibiotics, peritonitis, ascites, extensive abdominal surgery, contraindications to endoscopy, hypersensitivity to cephalosporins, or refused consent.
Total number of patients randomised; n = 37.

Interventions

'Pull' technique:
Group 1: cefoxitin 1 g IV 30 min prior to PEG (2 further doses given at 6 h intervals) (n = 17);
Group 2: saline placebo IV 30 min prior to PEG (n = 16).

Numbers originally randomised into groups not given in trial report

Outcomes

Peristomal infection.
Effect of gastric pH.
Microbiology of oropharyngeal flora and tip of tube.
Effect of underlying disease (neurological/malignancy).

Notes

Criteria for wound assessment: red, tender, indurated area at exit site with pain ± systemic signs of leukocytosis and fever.
Country of origin USA.
No power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random sequence generated by pharmacist.

Allocation concealment (selection bias)

Low risk

Allocation concealment as 'foil‐covered vials of identical appearance and equivalent volume' by pharmacy.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Stated: 'foil‐covered vials of identical appearance and equivalent volume'.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Stated: 'foil‐covered vials of identical appearance and equivalent volume'.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Known to pharmacist only.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

Four drop outs (10.8%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for malignancy, neurological disease.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed at more than three days (endpoint not stated).

Methods

Randomised controlled trial.

Participants

Consenting male and female patients, who had not received antibiotics in the preceding three days.

PEG tube inserted for neurological (n= 49), Cancer (n= 4) and miscellaneous (n= 5). (Taken from Table 1 ‐ 58 patients evaluable as 17 dropouts).
Excluded if allergic to penicillin, immunocompromised, had severe clotting disorder, end‐stage renal failure, or gastrointestinal surgery which precluded site of PEG.
Total number of patients randomised; n = 75.

Interventions

Technique not stated.
Group 1: co‐amoxiclav (dose not stated) IV 15‐30 min prior to PEG (n = 29);
Group 2: saline placebo IV 15‐30 min prior to PEG (n = 29).

Numbers originally randomised into groups not given in trial report

Outcomes

Peristomal infection.

Notes

Criteria for wound assessment: modified ASEPSIS scoring system used.
Country of origin England.
No power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'Provided by the hospital pharmacy'.

Allocation concealment (selection bias)

Low risk

Administered by 'endoscopist 15‐30 min prior to endoscopy with no prior knowledge of the sequence in the randomisation'.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

'The infection control team was blinded to the randomisation'.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

High risk

17 in total, seven died, eight drop outs, two lost to follow‐up (22.6%).

Comment: A 15% drop out rate makes the study at high risk of attrition bias.

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for age, gender, reasons for PEG.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed daily for seven days, and then day 28.

Methods

Randomised controlled trial.

Participants

Consenting male and female patients with dysphagia, 18 years and over.

PEG tube inserted for malignancy (n= 55) and neurological disease (n= 29) (Taken from Table 1 ‐ 84 patients evaluable on a per protocol analysis).
Excluded if had: allergy to penicillin; received antibiotics in past 4 days; neutropenia < 500 cells/microlitre; creatinine < 300 micromols/litre or contraindication to PEG.
Total number of patients randomised; n = 106.

Interventions

Thread 'pull' technique.
Group 1: co‐amoxiclav 2.2 g, by short infusion 30 min prior to PEG (n = 46).
Group 2: saline placebo, by short infusion 30 min prior to PEG (n = 47).

Numbers originally randomised into groups not given in trial report

Outcomes

Peristomal infection.
Mortality.
Adverse effects.

Notes

Included data from a previous study.
Used criteria by Jain et al for wound assessment.
Conducted in six hospitals.
Country of origin: Germany.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Permuted block design with separate sequences of random numbers for each centre to ensure equal numbers.

Allocation concealment (selection bias)

Low risk

Prepared by pharmacy.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Blinding of investigators, study nurses, reviewers and data managers.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Blinding of investigators, study nurses, reviewers and data managers.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Unclear risk

13 drop outs (12.3%). Report stated that ITT analysis was performed on 93 patients who received PEG but 106 patients were randomised and 13 people dropped out and there are no details on how this missing data were handled. The judgement is therefore unclear.

Selective reporting (reporting bias)

Low risk

Prespecified outcomes stated.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for age, gender, previous method of feeding, underlying conditions, performance status reason for PEG, Karnofsky index.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed daily for seven days and mortality at 30 days.

Methods

Randomised controlled trial.

Participants

Consenting male and female patients who had not received antibiotics in the preceding 2 days.

PEG tube inserted for CVA (n= 57), dementia (n= 10), neurogenic dysphagia (n= 11) and miscellaneous (n= 18).
Excluded if on antibiotic therapy, unable to gain consent, had allergy to cephalosporin or iodine, or required prophylaxis for endocarditis.
Total number of patients randomised; n = 96.

Interventions

'Pull' technique.
Group 1: cefuroxime 750 mg IV immediately prior to PEG (2 further doses given at 8 h intervals) (n = 34);
Group 2: povidone‐iodine spray only (n = 28);
Group 3: povidone‐iodine spray and cefuroxime 750 mg IV immediately prior to PEG (2 further doses given at 8 h intervals) (n = 34).

Outcomes

Peristomal infection.
Mortality.
Logistic regression effects of diabetes, steroids, acid suppressants, age and sex.

Notes

Used Jain et al wound assessment.
Some patients received antibiotics during follow‐up period.
Country of origin: England.
Power calculation not performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Closed envelopes opened at random by an endoscopy nurse.

Allocation concealment (selection bias)

Low risk

'Closed envelopes that were shuffled and opened at random by an endoscopy nurse after the patient had given consent for the study'.

Blinding (performance bias and detection bias)
Blinding patient

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding care provider

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Stomal site inspected by the investigator who was blinded to regime.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

No drop outs, five patient deaths in 1 week, 1 from gastric leakage on day 6 (5.2%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes addressed.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

All groups were balanced for age, gender, steroids, diabetes, size of PEG tube, reasons for PEG.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed on day three or four and day seven.

Methods

Randomised controlled trial.

Participants

Male and female patients over 16 years of age.

PEG tube inserted for CVA (n= 61), neurological (n= 35) and miscellaneous (n= 5). (Taken from Table 2 Error in paper as these total 101. The number quoted as 'analysable' for each outcome is 83 for peristomal infection, 97 for systemic infection, and 99 for seven‐day mortality).
Included if PEG was for non‐malignancy.
Excluded if had antibiotics within 48 h preceding PEG insertion.
Total number of patients randomised; n = 110.

Interventions

Pull technique.
Group 1: co‐amoxiclav 2.2 g (n = 43), or cefotaxime 2 g (if allergic to penicillin) (n = 8) at time of PEG tube insertion.
Group 2: placebo (not stated) at time of PEG tube insertion (n = 48).

Numbers originally randomised into groups not given in trial report

Outcomes

Peristomal infection.
Systemic infection.
Seven‐day mortality.

Notes

Used Jain et al criteria for wound assessment.
Country of origin: England.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'Done in advance using a random number generator'.

Allocation concealment (selection bias)

Low risk

'Study assignment cards kept with medication packs in pharmacy'.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

'Patient blinded'. Syringe covered with opaque sleeve prepared by endoscopy nurse.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Syringe covered with opaque sleeve prepared by endoscopy nurse.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

'Study investigator (outcome assessor) blinded'.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

11 withdrawals (10%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes addressed.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for age, gender, weight, underlying conditions.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed daily for seven days.

Methods

Randomised controlled trial.

Participants

Male and female patients 16‐89 years.

PEG tube inserted for cancer (n= 93). (Taken from Figure 1 ‐ 93 patients evaluable as 4 dropouts).
Included if had stenotic malignancy and lesions of the upper gastrointestinal tract.
Excluded if allergic to antibiotics, or had any contraindications to PEG.
Total number of patients randomised; n = 97.

Interventions

Push technique gastropexy PEG.
Group 1: ceftriaxone 2 g IV (n = 49);
Group 2: placebo ('similar looking') IV (n = 48).

Outcomes

Peristomal infection.

Notes

Used Jain et al and Gossner criteria for wound assessment.
Country of origin: Germany.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'Block randomisation and computer‐generated random numbers'.

Allocation concealment (selection bias)

Low risk

'Sequentially numbered, opaque, sealed envelopes'.

Blinding (performance bias and detection bias)
Blinding patient

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Injections prepared by non‐study staff.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Wound assessment by members of nutrition support team.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

Four drop outs (4.1%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for age, gender, BMI, location of malignancy, reason for PEG.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed daily for seven days.

Methods

Randomised controlled trial.

Participants

Characteristics of patients unclear.

PEG tube inserted for CVA and head and neck cancer (no numbers provided).
Excluded if unable to place PEG, inadequate access to follow‐up by medical personnel, or refused to sign consent form.
Total number of patients randomised; n = 115.

Interventions

Technique not stated.
Group 1: cefazolin 1 g IV within 30 min of PEG (n = 30);
Group 2: saline placebo IV within 30 min of PEG (n = 31);
Group 3: receiving antibiotics (including cephalosporins, penicillins, quinolones and sulphonamides) before and during the study which were continued for 24 h post PEG (n = 54).

Outcomes

Peristomal infection.
Gastric pH.
Wound cultures.

Notes

Group 3 excluded from analysis, as not randomised.
Used Jain et al criteria for wound assessment.
Country of origin: USA.

Power calculation not performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'Generated random sequence known only to those in the pharmacy'.

Allocation concealment (selection bias)

Low risk

Pharmacy dispensed 'Identical vials with equivalent volume'.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Unclear risk

Not stated.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

No drop outs.

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

All groups were balanced for age, reasons for PEG, underlying conditions.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in all groups were assessed daily for one week.