Day‐case versus overnight stay in laparoscopic cholecystectomy
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the benefits and harms of day‐case surgery compared to overnight stay in patients undergoing laparoscopic cholecystectomy.
Background
About 10% to 15% of the adult western population have gallstones (Jørgensen 1987; NIH 1992; Muhrbeck 1995; Halldestam 2004). Between 1% and 4% become symptomatic in a year (NIH 1992; Halldestam 2004). More than half a million cholecystectomies are performed per year in the United States alone (NIH 1992). Regional differences exist in the cholecystectomy rates (Mjäland 1998). Laparoscopic cholecystectomy, which was introduced in 1987, is now the preferred method of cholecystectomy (NIH 1992; Fullarton 1994; Bakken 2004; Keus 2006).
Although laparoscopic cholecystectomy is safe during acute cholecystitis (Gurusamy 2006), only about 30% of the laparoscopic cholecystectomies in the United States are performed during acute cholecystitis (Livingston 2004). Only 20% of surgeons in the United Kingdom perform laparoscopic cholecystectomy during acute cholecystitis (Senapati 2003).
Although 50000 cholecystectomies are performed annually in the UK (includes open cholecystectomies, laparoscopic cholecystectomies during acute cholecystitis), only about 3,300 patients are performed as day‐case (HES 2006). While day‐case laparoscopic cholecystectomy can save costs (Keulemans 1998; Johansson 2006), concerns remain about the safety of the patient. Bleeding after laparoscopic cholecystectomy (due to vascular injury or due to cystic artery bleeding) is one of the serious complications after laparoscopic cholecystectomy (Shamiyeh 2004). Bile duct injury is another important complication after laparoscopic cholecystectomy (Waage 2006). Whether the patients feel safer if they were observed overnight is also debatable (Keulemans 1998). Another factor that has to be taken into consideration is the pain relief that the patient requires and the safety of discharging these patients on adequate pain relief. Various methods such as peritoneal instillation of normal saline (Tsimoyiannis 1998) or local anaesthetic (Tsimoyiannis 1998) and wound infiltration with local anaesthetic (Lepner 2003) have been attempted to decrease the analgesic requirements. Post‐operative nausea and vomiting are other factors which need attention. Various methods have been tried to decrease the incidence of post‐operative nausea and vomiting (Argiriadou 2002; Pandey 2006).
Advocates of day‐case laparoscopy argue that major bleeding after laparoscopic cholecystectomy is a rare event (Keulemans 1998) and that bile duct injury is either detected at the time of injury or several days later (Keulemans 1998). There was no difference in the mean pain score whether the patients were discharged as day‐case or whether they stayed overnight (Keulemans 1998). There was also no difference in the patient anxiety (Johansson 2006) or in the quality of their life (Keulemans 1998) whether they were discharged as day case or whether they stayed overnight.
We have not been able to identify any systematic review or meta‐analysis comparing day case and overnight stay laparoscopic cholecystectomy.
Objectives
To assess the benefits and harms of day‐case surgery compared to overnight stay in patients undergoing laparoscopic cholecystectomy.
Methods
Criteria for considering studies for this review
Types of studies
Only randomised clinical trials (irrespective of language, blinding, or publication status) will be considered for this review.
Quasi‐randomised studies (where the method of allocating participants to a treatment are not strictly random (eg, date of birth, hospital record number, alternation), cohort studies, and case‐control studies will not be considered for inclusion.
Types of participants
Patients undergoing elective laparoscopic cholecystectomy.
Types of interventions
We will include trials comparing day‐case laparoscopic cholecystectomy versus overnight stay laparoscopic cholecystectomy.
Types of outcome measures
(1) Mortality.
(2) Surgery‐related morbidity (bile duct injury, intra‐abdominal collections, wound infection, infected intra‐abdominal collections).
(3) Surgery related morbidity noted after discharge.
(4) Prolonged hospitalisation.
(5) Re‐admission.
(6) Reviewed by doctor but not admitted.
(7) Pain (however defined by authors).
(8) Nausea (however defined by authors).
(9) Vomiting (however defined by authors).
(10) Patient anxiety (however defined by authors).
(11) Quality of life of patients (however defined by authors).
(12) Ret run to normal activity.
(13) Return to work.
Search methods for identification of studies
We will search The Cochrane Hepato‐Biliary Group Controlled Trials Register, theCochrane Central Register of Controlled Trials (CENTRAL) inThe Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded (Royle 2003). We have given preliminary search strategies in Table 1 with the time span for the searches. As the review progresses, we will improve the search strategy.
| Database | Period of Search | Search Strategy |
| The Cochrane Hepato‐Biliary Group Controlled Trials Register | Date will be given at review status. | ("day case" OR day‐case OR "day surgery" or day‐surgery OR "day care" OR day‐care OR "day stay" OR day‐stay OR ambulatory OR outpatient OR out‐patient OR (partial and (hospitalization or hospitalizations or hospitalisation or hospitalizations)) AND (((laparoscop* OR celioscop* OR coelioscop* OR abdominoscop* OR peritoneoscop*) AND (cholecystecto* OR colecystecto*)) |
| Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library | Latest issue. | #1 "day case" OR day‐case OR "day surgery" or day‐surgery OR "day care" OR day‐care OR "day stay" OR day‐stay OR ambulatory OR outpatient OR out‐patient OR (partial and (hospitalization or hospitalizations or hospitalisation or hospitalizations)) |
| MEDLINE | 1987 to the date of search. | ("day case" OR day‐case OR "day surgery" or day‐surgery OR "day care" OR day‐care OR "day stay" OR day‐stay OR ambulatory OR outpatient OR out‐patient OR (partial and (hospitalization or hospitalizations or hospitalisation or hospitalizations)) OR "Day Care"[MeSH] OR "Ambulatory Surgical Procedures"[MeSH] OR "Ambulatory Care"[MeSH]) AND (((laparoscop* OR celioscop* OR coelioscop* OR abdominoscop* OR peritoneoscop*) AND (cholecystecto* OR colecystecto*)) OR "cholecystectomy, laparoscopic"[MeSH]) AND (((randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double‐blind method [mh] OR single‐blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR ("clinical trial" [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR (placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp]) NOT (animals [mh] NOT human [mh])))) |
| EMBASE | 1987 to the date of search. | 1 day ADJ case OR day‐case OR day ADJ surgery OR day‐surgery OR day ADJ care OR day‐care OR day ADJ stay OR day‐stay OR ambulatory OR outpatient OR out‐patient |
| Science Citation Index Expanded (http://portal.isiknowledge.com/portal.cgi?DestApp=WOS&Func=Frame) | 1987 to the date of search. | #1 TS=("day case" OR day‐case OR "day surgery" or day‐surgery OR "day care" OR day‐care OR "day stay" OR day‐stay OR ambulatory OR outpatient OR out‐patient) |
Data collection and analysis
Trial selection and extraction of data
We will not apply any language or publication status restrictions. KG and SJ, independently of each other, will identify the trials for inclusion. We will also listed the excluded trials with the reasons for the exclusion. We will also search the references of the identified trials to identify further relevant trials.
KG and SJ will extract independently the data listed below:
(1) Year and language of publication.
(2) Country.
(3) Year of study.
(4) Inclusion and exclusion criteria.
(5) Sample size.
(6) Abdominal wall lift or pneumoperitoneum.
(7) Pressure used for pneumoperitoneum.
(8) Drain use.
(9) Method of pain relief.
(10) Method of control of nausea and vomiting.
(11) Number of hours of stay in each group (as per protocol) and actual hours of stay.
(12) Outcomes (mentioned above).
(13) Methodological quality (described below).
(14) Sample size calculation.
(15) Intention‐to‐treat analysis.
We will assess the methodological quality of the trials independently, without masking of the trial names. Any unclear or missing information will be sought by contacting the authors of the individual trials. If there is any doubt whether the trials share the same patients ‐ completely or partially (by identifying common authors and centres), we will contact the authors of the trials to clarify whether the trial has been duplicated. We will resolve any differences in opinion through discussion.
Assessment of methodological quality
The authors will follow the instructions given in the Cochrane Handbook for Systematic Reviews of Intervention (Higgins 2006) and the Cochrane Hepato‐Biliary Group Module (Gluud 2006). Due to the risk of overestimation of intervention effects in randomised trials with inadequate methodological quality (Schulz 1995; Moher 1998; Kjaergard 2001), we will look at the influence of methodological quality of the trials on the trial results by evaluating the reported randomisation and follow‐up procedures in each trial. If information was not available in the published trial, we will contact the authors in order to assess the trials correctly. We will assess generation of allocation sequence, allocation concealment, and follow‐up.
Generation of the allocation sequence
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Adequate, if the allocation sequence was generated by a computer or random number table. Drawing of lots, tossing of a coin, shuffling of cards, or throwing dice will be considered as adequate if a person who was not otherwise involved in the recruitment of participants performed the procedure.
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Unclear, if the trial was described as randomised, but the method used for the allocation sequence generation was not described.
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Inadequate, if a system involving dates, names, or admittance numbers were used for the allocation of patients. These studies are known as quasi‐randomised and will be excluded from the review.
Allocation concealment
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Adequate, if the allocation of patients involved a central independent unit, on‐site locked computer, or sealed envelopes.
-
Unclear, if the trial was described as randomised, but the method used to conceal the allocation was not described.
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Inadequate, if the allocation sequence was known to the investigators who assigned participants or if the study was quasi‐randomised (such studies will be excluded).
Blinding will not be assessed as it is impossible to blind the patient to the group to which they belonged to. It is also difficult to assess outcomes such as pain or nausea on the day of surgery in a blinded fashion. However, it is possible to blind outcomes such as decision to re‐admit, quality of life after one week, return to activity etc. So, we will record whether any of the outcomes were assessed by a blinded observer.
Follow‐up
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Adequate, if the numbers and reasons for dropouts and withdrawals in all intervention groups were described or if it was specified that there were no dropouts or withdrawals.
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Unclear, if the report gave the impression that there had been no dropouts or withdrawals, but this was not specifically stated.
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Inadequate, if the number or reasons for dropouts and withdrawals were not described.
Statistical methods
We will perform the meta‐analyses according to the recommendations of The Cochrane Collaboration (Higgins 2006) and the Cochrane Hepato‐Biliary Group Module (Gluud 2006) using the software package RevMan 4.2 (RevMan 2003). For dichotomous variables, we will calculate the relative risk with 95% confidence interval. For the continuous variables, we will calculate the standardised mean difference for outcomes such as quality of life, where different scales are possible and the weighted mean difference for other outcomes. We will use a random‐effects model (DerSimonian 1986) and a fixed‐effect model (DeMets 1987). In case of discrepancy between the two models we will report both results, otherwise we will report the fixed model. Statistical heterogeneity will be explored by chi‐squared test with significance set at P value 0.10, and the quantity of heterogeneity will be measured by I2 (Higgins 2002). An I2 value =>25 will be considered as statistical heterogeneity.
We will adopt the 'available case analysis' (Higgins 2006). The analysis will be performed on an intention‐to‐treat basis (Newell 1992). In case we find 'zero‐event' trials for outcomes that are statistically significant without including the 'zero‐event' trials, we will perform a sensitivity analysis with and without empirical continuity correction factors as suggested by Sweeting et al (Sweeting 2004).
Subgroup analysis
We will perform subgroup analyses for:
‐ Trials including different age groups of patients.
‐ Different pressures of pneumoperitoneum compared to no pneumoperitoneum (abdominal wall lift).
‐ Different methods of pain relief (eg, intra‐peritoneal instillation of saline or local anaesthetic; local infiltration of bupivacaine).
‐ Different medications for nausea and vomiting (eg, ondansetron, gabapentin).
‐ Methodological quality and hence bias risk of the trials.
Bias exploration
We will use a funnel plot to explore bias (Egger 1997; Macaskill 2001). Asymmetry in funnel plot of trial size against treatment effect will used to assess the risk of bias. We will perform linear regression approach described by Egger et al (Egger 1997) to determine the funnel plot asymmetry.
| Database | Period of Search | Search Strategy |
| The Cochrane Hepato‐Biliary Group Controlled Trials Register | Date will be given at review status. | ("day case" OR day‐case OR "day surgery" or day‐surgery OR "day care" OR day‐care OR "day stay" OR day‐stay OR ambulatory OR outpatient OR out‐patient OR (partial and (hospitalization or hospitalizations or hospitalisation or hospitalizations)) AND (((laparoscop* OR celioscop* OR coelioscop* OR abdominoscop* OR peritoneoscop*) AND (cholecystecto* OR colecystecto*)) |
| Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library | Latest issue. | #1 "day case" OR day‐case OR "day surgery" or day‐surgery OR "day care" OR day‐care OR "day stay" OR day‐stay OR ambulatory OR outpatient OR out‐patient OR (partial and (hospitalization or hospitalizations or hospitalisation or hospitalizations)) |
| MEDLINE | 1987 to the date of search. | ("day case" OR day‐case OR "day surgery" or day‐surgery OR "day care" OR day‐care OR "day stay" OR day‐stay OR ambulatory OR outpatient OR out‐patient OR (partial and (hospitalization or hospitalizations or hospitalisation or hospitalizations)) OR "Day Care"[MeSH] OR "Ambulatory Surgical Procedures"[MeSH] OR "Ambulatory Care"[MeSH]) AND (((laparoscop* OR celioscop* OR coelioscop* OR abdominoscop* OR peritoneoscop*) AND (cholecystecto* OR colecystecto*)) OR "cholecystectomy, laparoscopic"[MeSH]) AND (((randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double‐blind method [mh] OR single‐blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR ("clinical trial" [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR (placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp]) NOT (animals [mh] NOT human [mh])))) |
| EMBASE | 1987 to the date of search. | 1 day ADJ case OR day‐case OR day ADJ surgery OR day‐surgery OR day ADJ care OR day‐care OR day ADJ stay OR day‐stay OR ambulatory OR outpatient OR out‐patient |
| Science Citation Index Expanded (http://portal.isiknowledge.com/portal.cgi?DestApp=WOS&Func=Frame) | 1987 to the date of search. | #1 TS=("day case" OR day‐case OR "day surgery" or day‐surgery OR "day care" OR day‐care OR "day stay" OR day‐stay OR ambulatory OR outpatient OR out‐patient) |
