Laparoscopic cholecystectomy versus mini-laparotomy cholecystectomy - A prospective, randomized, single-blind study

Objective To analyze outcomes after open small-incision surgery (minilaparo tomy) and laparoscopic surgery for gallstone disease in general surgical pr actice. Methods This study was a randomized, single-blind, multicenter trial compar ing laparoscopic cholecystectomy (LC) to minilaparotomy cholecystectomy (MC ). Both elective and acute patients were eligible for inclusion. All surgeo ns normally performing cholecystectomy, both trainees under supervision and consultants, operated on randomized patients. LC was a routine procedure a t participating hospitals, whereas MC was introduced after a short training period. All nonrandomized cholecystectomies at participating units during the study period were also recorded to analyze the external validity of tri al results. The randomization period was from March 1, 1997, to April 30, 1 999. Results Of 1,705 cholecystectomies performed at participating units during the randomization period, 724 entered the trial and 362 patients were rando mized to each of the procedures. The groups were well matched for age and s ex, but there were fewer acute operations in the LC group than the MC group . In the LC group 264 and in the MC group 150 operations were performed by surgeons who had done more than 25 operations of that type. Median operatin g times were 100 and 85 minutes for LC and MC, respectively. Median hospita l stay was 2 days in each group, but in a nonparametric test it was signifi cantly shorter after LC. Median sick leave and time for return to normal re creational activities were shorter after LC than MC. Intraoperative complic ations were less frequent in the MC group, but there was no difference in t he postoperative complication rate between the groups. There was one seriou s bile duct injury in each group, but no deaths. Conclusions Operating time was longer and convalescence was smoother for LC compared with MC. Further analyses of LC versus MC are necessary regarding surgical training, surgical outcome, and health economy.