Conventional versus laparoscopic cholecystectomy and the randomized controlled trial. Cholecystectomy Study Group.

We considered using a randomized trial to assess the value of laparoscopic cholecystectomy in the treatment of symptomatic gallstones. The pros and cons for the timing of such a trial were in favour of not beginning the trial until surgeons learned to use the new procedure safely and effectively, and until key endpoints and outcome indices could be identified and assessed using valid measures. Instead an observational study was implemented to monitor the learning curve of surgeons as they mastered the laparoscopic equipment and procedures, and to assess the responses of the patients to the procedure. In the first 100 patients, the procedure proved to be as safe and feasible to use as conventional surgery, and there were strong benefits in terms of quicker recovery of the patients with less pain, discomfort, and a reduced length of hospital stay. The responses of the surgeons and the patients to the new procedure now place ethical constraints on the planning of a randomized controlled trial. Currently, comprehensive surveillance and monitoring of laparoscopic cholecystectomy is the only realistic method with which to assess the impact of this new technology in our clinic.