Purpose: A randomized, controlled trial is considered to be the "gold standard" to evaluate a new procedure. Thus, this critical review assessed whether the published randomized trials on laparoscopic appendectomy show that it is superior to the open approach.
Methods: Twelve original articles involving a randomized, controlled trial on laparoscopic appendectomy in adults published between January 1990 and December 1996 were selected. We studied first whether each trial was positive (a procedure is superior to the other) or negative (no difference). We reviewed for each trial the methodology used and the following outcomes: operating time, intraoperative and postoperative complications, time until resumption of diet, postoperative pain, hospital stay, cost, and quality of life analyses. Postoperative morbidity was considered as the major primary outcome.
Results: There were six positive and six negative trials. Postoperative complication rates were similar, but the two approaches had specific potential complications, wound infections following open appendectomy, and intra-abdominal abscesses following laparoscopic appendectomy. This review failed to show a superiority of the laparoscopy for the other outcomes, particularly postoperative pain.
Conclusion: Differences in positive trials concerned subjective and controversial outcomes, and the flaw in negative trials was their lack of power. Thus, nothing is definitively well established, even after 12 randomized trials.