PURPOSE: Open pyloromyotomy remains as the criterion standard treatment for hypertrophic pyloric stenosis with the laparoscopic approach rapidly gaining adoption. We present a prospective, randomized trial between the 2 approaches. METHODS: After institutional review board approval, 98 patients with hypertrophic pyloric stenosis were consecutively randomized to either open or laparoscopic pyloromyotomy. Postoperative and hospital course were evaluated by review of the hospital records and long-term follow-up with scripted telephone survey using Likert scales. The length of operating room time, surgical procedure, postoperative stay, time to refeeding, and complications were evaluated. Secondary outcomes of cosmetic results and parental satisfaction were determined. RESULTS:Ninety-eight patients were enrolled during a 4-year period. There were no significant differences between 2 groups on all primary outcomes. There were 3 complications in the open group-a wound dehiscence, a surgical site infection, and a gastric serosal tear-and 2 complications in the laparoscopic group-mucosal perforation and a suture granuloma. In long-term follow-up on 72 patients (56 months), parents described significant cosmetic results with laparoscopic approach. CONCLUSIONS: There was no difference in operating time, hospital stay, or refeeding patterns between open and laparoscopic pyloromyotomy. The complication rates were similar between the 2 methods. However, long-term cosmetic results were significantly superior in the laparoscopic group.
RCT Entities:
PURPOSE: Open pyloromyotomy remains as the criterion standard treatment for hypertrophic pyloric stenosis with the laparoscopic approach rapidly gaining adoption. We present a prospective, randomized trial between the 2 approaches. METHODS: After institutional review board approval, 98 patients with hypertrophic pyloric stenosis were consecutively randomized to either open or laparoscopic pyloromyotomy. Postoperative and hospital course were evaluated by review of the hospital records and long-term follow-up with scripted telephone survey using Likert scales. The length of operating room time, surgical procedure, postoperative stay, time to refeeding, and complications were evaluated. Secondary outcomes of cosmetic results and parental satisfaction were determined. RESULTS: Ninety-eight patients were enrolled during a 4-year period. There were no significant differences between 2 groups on all primary outcomes. There were 3 complications in the open group-a wound dehiscence, a surgical site infection, and a gastric serosal tear-and 2 complications in the laparoscopic group-mucosal perforation and a suture granuloma. In long-term follow-up on 72 patients (56 months), parents described significant cosmetic results with laparoscopic approach. CONCLUSIONS: There was no difference in operating time, hospital stay, or refeeding patterns between open and laparoscopic pyloromyotomy. The complication rates were similar between the 2 methods. However, long-term cosmetic results were significantly superior in the laparoscopic group.
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