Laparoscopic pyloromyotomy for hypertrophic pyloric stenosis: a prospective, randomized controlled trial

Background: Several authors have reported on laparoscopic pyloromyotomy (LP) since the technique was originally described in 1990, but its benefits remain unproven. We performed a randomized controlled trial comparing LP to open circumumbilical pyloromyotomy (OP) for hypertrophic pyloric stenosis. Methods: In a prospective study, 102 infants with pyloric stenosis were randomly assigned to either LP (n = 50) or OP (n = 52). The primary outcome measure was the incidence of postoperative vomiting; the secondary parameters were the durations of surgery and anesthesia, surgical complications, and postoperative pain. All infants were managed according to standardized procedures regarding general anesthesia, surgical technique, postoperative analgesia, and feeding regimen. Parents, carers, and assessors responsible for the postoperative evaluation were blinded for the technique used. Results: There was no difference in the incidence of postoperative vomiting between the 2 groups. The overall incidence of complications was similar, but the durations of surgery and general anesthesia were significantly longer in the LP group than in the OP group (P = 10(-4) and P = .02, respectively). There were 3 cases of incomplete pyloromyotomy after laparoscopy, requiring a repeat procedure. Conclusions: Laparoscopic pyloromyotomy does not decrease the incidence of postoperative vomiting, has a similar complication rate compared with the open umbilical approach, but may expose patients to a risk of inadequate pyloromyotomy. (C) 2007 Elsevier Inc. All rights reserved.