Background
Approximately 50 to 250 out of every 1000 adults in the western world have gallstones. Of every 100 people with gallstones, two to four people develop symptoms such as pain in the upper abdomen. This condition is treated by surgical removal of the gallbladder through 'keyhole surgery', a procedure that is known as laparoscopic cholecystectomy. It is possible to perform the operation and allow the patient to go home on the same day ('day surgery'). During surgery, the patient is given a range of medicines to provide lack of awareness of the procedure undertaken, reduce pain, and relax muscles (allowing the surgeon adequate access and vision). Together, this is called an anaesthetic regimen. Many different anaesthetic regimens have been suggested for use in day-procedure laparoscopic cholecystectomy. We sought to find the best anaesthetic regimen by performing a thorough search of the literature for randomized controlled trials, reported until November 2013.
Study characteristics
We included 11 trials involving 1069 patients in this review. Most participants in the trials had a low anaesthetic risk.
Key results
There were no deaths or serious complications in the only trial that reported this information. Overall, 85% of patients (472/554) were discharged as day-procedure laparoscopic cholecystectomy patients and 2% of patients (1/60) required hospital readmission. The reasons for not discharging the patients as day-procedure patients were not described in detail in the trials. The reason for readmission was fever that developed in the patient and which subsequently settled on its own without any treatment. Quality of life was not reported in any of the trials. There was no clear evidence of a difference in the measures of pain intensity between any of the comparisons. Time to return to routine daily activity and to return to work were not reported in any of the trials. There is currently no evidence to support one anaesthetic regimen for day-procedure laparoscopic cholecystectomy over another.
Quality of evidence
All the trials had elements that tended to reduce our trust in the accuracy of the results. Few patients were included in each comparison resulting in a considerable chance of arriving at erroneous conclusions.
Future research
Randomized controlled trials designed to minimize the risk of arriving at wrong conclusions are necessary to determine the best anaesthetic regimen for day-procedure laparoscopic cholecystectomy, one of the commonest procedures performed in the western world.
There is currently insufficient evidence to conclude that one anaesthetic regimen for day-procedure laparoscopic cholecystectomy is to be preferred over another. However, the data are sparse (that is, there were few trials under each comparison and the trials had few participants) and further well designed randomized trials at low risk of bias and which are powered to measure differences in clinically important outcomes are necessary to determine the optimal anaesthetic regimen for day-procedure laparoscopic cholecystectomy, one of the commonest procedures performed in the western world.
Day surgery involves admission of selected patients to hospital for a planned surgical procedure with the patients returning home on the same day. An anaesthetic regimen usually involves a combination of an anxiolytic, an induction agent, a maintenance agent, a method of maintaining the airway (laryngeal mask versus endotracheal intubation), and a muscle relaxant. The effect of anaesthesia may continue after the completion of surgery and can delay discharge. Various regimens of anaesthesia have been suggested for day-procedure laparoscopic cholecystectomy.
To compare the benefits and harms of different anaesthetic regimens (risks of mortality and morbidity, measures of recovery after surgery) in patients undergoing day-procedure laparoscopic cholecystectomy.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 10, 2013), MEDLINE (PubMed) (1987 to November 2013), EMBASE (OvidSP) (1987 to November 2013), Science Citation Index Expanded (ISI Web of Knowledge) (1987 to November 2013), LILACS (Virtual Health Library) (1987 to November 2013), metaRegister of Controlled Trials (http://www.controlled-trials.com/mrct/) (November 2013), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) portal (November 2013), and ClinicalTrials.gov (November 2013).
We included randomized clinical trials comparing different anaesthetic regimens during elective day-procedure laparoscopic cholecystectomy (irrespective of language or publication status).
Two authors independently assessed trials for inclusion and independently extracted the data. We calculated the risk ratio, rate ratio or mean difference with 95% confidence intervals based on intention-to-treat or available data analysis.
We included 11 trials involving 1069 participants at low anaesthetic risk. The sample size varied from 40 to 300 participants. We included 23 comparisons. All trials were at a high risk of bias. We were unable to perform a meta-analysis because there were no two trials involving the same comparison. Primary outcomes included perioperative mortality, serious morbidity and proportion of patients who were discharged on the same day. There were no perioperative deaths or serious adverse events in either group in the only trial that reported this information (0/60). There was no clear evidence of a difference in the proportion of patients who were discharged on the same day between any of the comparisons. Overall, 472/554 patients (85%) included in this review were discharged as day-procedure laparoscopic cholecystectomy patients. Secondary outcomes included hospital readmissions, health-related quality of life, pain, return to activity and return to work. There was no clear evidence of a difference in hospital readmissions within 30 days in the only comparison in which this outcome was reported. One readmission was reported in the 60 patients (2%) in whom this outcome was assessed. Quality of life was not reported in any of the trials. There was no clear evidence of a difference in the pain intensity, measured by a visual analogue scale, between comparators in the only trial which reported the pain intensity at between four and eight hours after surgery. Times to return to activity and return to work were not reported in any of the trials.