Summary Background Data: The value of laparoscopy in appendicitis is not established. Studies suffer from multiple limitations. Our aim is to compare the safety and benefits of laparoscopic versus open appendectomy in a prospective randomized double blind study.Methods: Two hundred forty-seven patients were analyzed following either laparoscopic or open appendectomy. A standardized wound dressing was applied blinding both patients and independent data collectors. Surgical technique was standardized among 4 surgeons. The main outcome measures were postoperative complications. Secondary outcome measures included evaluation of pain and activity scores at base line preoperatively and on every postoperative day, as well as resumption of diet and length of stay. Activity scores and quality of life were assessed on short-term follow-up.Results: There was no mortality. The overall complication rate was similar in both groups (18.5% versus 17% in the laparoscopic and open groups respectively), but some early complications in the laparoscopic group required a reoperation. Operating time was significantly longer in the laparoscopic group (80 minutes versus 60 minutes; P = 0.000) while there was no difference in the pain scores and medications, resumption of diet, length of stay, or activity scores. At 2 weeks, there was no difference in the activity or pain scores, but physical health and general scores on the short-form 36 (SF36) quality of life assessment forms were significantly better in the laparoscopic group. Appendectomy for acute or complicated (perforated and gangrenous) appendicitis had similar complication rates, regardless of the technique (P = 0.181).Conclusions: Unlike other minimally invasive procedures, laparoscopic appendectomy did not offer a significant advantage over open appendectomy in all studied parameters except quality of life scores at 2 weeks. It also took longer to perform. The choice of the procedure should be based on surgeon or patient preference.
Introduction
Since its initial description by Semm[1] in 1983, laparoscopic appendectomy (LA) has struggled to prove its superiority over the open technique. This is in contrast to laparoscopic cholecystectomy, which has promptly become the gold standard for gallstone disease despite little scientific challenge.[2] Open appendectomy (OA) has withstood the test of time for more than a century since its introduction by McBurney:[3] the procedure is standardized among surgeons and, unlike cholecystectomy, OA is typically completed using a small right lower quadrant incision and postoperative recovery is usually uneventful. It is the second most common general surgical procedure performed in the United States, after laparoscopic cholecystectomy, and the most common intraabdominal surgical emergency, with a lifetime risk of 6%. The overall mortality of OA is around 0.3%; and morbidity, about 11%.[4] Given the large number of procedures done annually, the validation of a minimally invasive technique that would improve outcomes may have a direct impact on patient management and possibly an indirect effect on the economics of health care.
Numerous prospective randomized studies,[5-26] meta-analyses,[27-30] and systematic critical reviews[31-34] have been published on the topic of LA, with a general consensus that the heterogeneity of the measured variables and other weaknesses in the methodology have not allowed to draw definitive conclusions and generalizations.[33,34]
With this in mind, we have designed a prospective randomized study (PRS) comparing LA to OA that included double blinding of the patient and the independent data collector, a factor missing in all but 2 PRS.[11,23]
Introduction
Since its initial description by Semm[1] in 1983, laparoscopic appendectomy (LA) has struggled to prove its superiority over the open technique. This is in contrast to laparoscopic cholecystectomy, which has promptly become the gold standard for gallstone disease despite little scientific challenge.[2] Open appendectomy (OA) has withstood the test of time for more than a century since its introduction by McBurney:[3] the procedure is standardized among surgeons and, unlike cholecystectomy, OA is typically completed using a small right lower quadrant incision and postoperative recovery is usually uneventful. It is the second most common general surgical procedure performed in the United States, after laparoscopic cholecystectomy, and the most common intraabdominal surgical emergency, with a lifetime risk of 6%. The overall mortality of OA is around 0.3%; and morbidity, about 11%.[4] Given the large number of procedures done annually, the validation of a minimally invasive technique that would improve outcomes may have a direct impact on patient management and possibly an indirect effect on the economics of health care.
Numerous prospective randomized studies,[5-26] meta-analyses,[27-30] and systematic critical reviews[31-34] have been published on the topic of LA, with a general consensus that the heterogeneity of the measured variables and other weaknesses in the methodology have not allowed to draw definitive conclusions and generalizations.[33,34]
With this in mind, we have designed a prospective randomized study (PRS) comparing LA to OA that included double blinding of the patient and the independent data collector, a factor missing in all but 2 PRS.[11,23]
