BACKGROUND:Pyloric stenosis, the most common surgical condition of infants, is treated by longitudinal myotomy of the pylorus. Comparative studies to date between open and laparoscopic pyloromyotomy have been retrospective and report conflicting results. To scientifically compare the 2 techniques, we conducted the first large prospective, randomized trial between the 2 approaches. METHODS: After obtaining IRB approval, subjects with ultrasound-proven pyloric stenosis were randomized to either open or laparoscopic pyloromyotomy. Postoperative pain management, feeding schedule, and discharge criteria were identical for both groups. Operating time, postoperative emesis, analgesia requirements, time to full feeding, length of hospitalization after operation, and complications were compared. RESULTS:From April 2003 through March 2006, 200 patients were enrolled in the study. There were no significant differences in operating time, time to full feeding, or length of stay. There were significantly fewer number of emesis episodes and doses of analgesia given in the laparoscopic group. One mucosal perforation and one incisional hernia occurred in the open group. Late in the study, 1 patient in the laparoscopic group was converted to the open operation. A wound infection occurred in 4 of the open patients compared with 2 of the laparoscopic patients (P = 0.68). CONCLUSIONS: There is no difference in operating time or length of recovery between open and laparoscopic pyloromyotomy. However, the laparoscopic approach results in less postoperative pain and reduced postoperative emesis. In addition, there was a fewer number of complications in the laparoscopic group. Finally, patients approached laparoscopically will likely display superior cosmetic outcomes with long-term follow-up.
RCT Entities:
BACKGROUND:Pyloric stenosis, the most common surgical condition of infants, is treated by longitudinal myotomy of the pylorus. Comparative studies to date between open and laparoscopic pyloromyotomy have been retrospective and report conflicting results. To scientifically compare the 2 techniques, we conducted the first large prospective, randomized trial between the 2 approaches. METHODS: After obtaining IRB approval, subjects with ultrasound-proven pyloric stenosis were randomized to either open or laparoscopic pyloromyotomy. Postoperative pain management, feeding schedule, and discharge criteria were identical for both groups. Operating time, postoperative emesis, analgesia requirements, time to full feeding, length of hospitalization after operation, and complications were compared. RESULTS: From April 2003 through March 2006, 200 patients were enrolled in the study. There were no significant differences in operating time, time to full feeding, or length of stay. There were significantly fewer number of emesis episodes and doses of analgesia given in the laparoscopic group. One mucosal perforation and one incisional hernia occurred in the open group. Late in the study, 1 patient in the laparoscopic group was converted to the open operation. A wound infection occurred in 4 of the open patients compared with 2 of the laparoscopic patients (P = 0.68). CONCLUSIONS: There is no difference in operating time or length of recovery between open and laparoscopic pyloromyotomy. However, the laparoscopic approach results in less postoperative pain and reduced postoperative emesis. In addition, there was a fewer number of complications in the laparoscopic group. Finally, patients approached laparoscopically will likely display superior cosmetic outcomes with long-term follow-up.
Authors: Brendan T Campbell; Kelly McLean; Douglas C Barnhart; Robert A Drongowski; Ronald B Hirschl Journal: J Pediatr Surg Date: 2002-07 Impact factor: 2.545
Authors: Daniel J Ostlie; Charles E Woodall; Kerri R Wade; Charles L Snyder; George K Gittes; Ronald J Sharp; Walter S Andrews; J Patrick Murphy; George W Holcomb Journal: Surgery Date: 2004-10 Impact factor: 3.982
Authors: Elke Zani-Ruttenstock; Augusto Zani; Emma Bullman; Eveline Lapidus-Krol; Agostino Pierro Journal: Pediatr Surg Int Date: 2014-11-05 Impact factor: 1.827