Laparoscopic Cholecystectomy Versus Mini-Laparotomy Cholecystectomy: A Prospective, Randomized, Single-Blind Study

Changes in surgical technique, retrospectively recognized as being advantageous, have often been preceded by more than a decade of interest among devoted specialists before being introduced into surgical practice at large. Total mesorectal excision in the treatment of rectal cancer 1 and the use of mesh in hernia surgery 2,3 exemplify this. During the 1980s and in the early 1990s, it was shown that the conventional large subcostal incision in cholecystectomy could be replaced by a much smaller incision, giving a shorter convalescence. 4–6 This conclusion was later supported by results in three 7–9 out of four 7–10 randomized controlled trials. When laparoscopic cholecystectomy (LC) was introduced in the late 1980s, it rapidly became the dominant procedure for gallbladder surgery in the industrialized world. The main reason was that the new method was followed by a smoother postoperative course than conventional cholecystectomy. 11–13 LC has been found to take a longer time to perform and to cause less postoperative pain than small-incision surgery, or minilaparotomy cholecystectomy (MC), whereas divergent results have been obtained with respect to hospital stay and convalescence. 14–18 The external validity (generalizability) of these studies is difficult to assess because with the exception of one study, 17 surgery was performed by specialist surgeons, trainees not being involved. Further, the surgeons may not have been equally familiar with the two techniques studied, and a difference in this respect is known to affect the outcome of a randomized trial. 19 It was therefore considered of interest to compare these two techniques in a routine healthcare situation (i.e., operations performed by junior surgeons under supervision as well as by consultants). The study should have an epidemiologic approach, taking into account all cholecystectomies in the observed population whether performed as part of the trial or not. The familiarity of surgeons with the methods studied should also be documented. We performed such a study as a randomized, single-blind, multicenter trial. We hypothesized that the postoperative courses after LC and MC would not differ significantly, and that LC would be more expensive when taking into account the overall cost to society.