ArticlesRecovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial
Introduction
Infantile hypertrophic pyloric stenosis is one of the most common neonatal conditions needing surgery. Ramstedt's pyloromyotomy for pyloric stenosis, first described in 1912,1 is still a safe, effective procedure with a low risk of complications. After the introduction of small (3–5 mm) laparoscopic equipment to enable access into the abdomen of infants, laparoscopic pyloromyotomy was described in 1991,2 and several centres have used this technique. Initial reports of better cosmesis and faster postoperative recovery after this procedure3, 4, 5, 6, 7 were not subsequently confirmed.8, 9, 10 Some authors have questioned the safety of laparoscopy because of increased frequency of surgical complications compared with open pyloromyotomy.11, 12
We did a systematic review and meta-analysis of published data up to 2004,13 which suggested that postoperative recovery was shorter after laparoscopy than after open pyloromyotomy, but raised concerns of a higher complication rate. At that time, no large randomised controlled trials had been done to compare these two procedures, but only retrospective studies, mainly from single institutions. Recently, two large studies have been reported at single centres in North America14 and France.15 One14 indicated that laparoscopy was better than open pyloromyotomy because of fewer episodes of postoperative vomiting and decreased need for postoperative analgesia, whereas the other15 concluded the opposite because of a slightly increased risk of incomplete pyloromyotomy after laparoscopy. Table 1 shows main outcomes from all comparative studies of laparoscopy and open pyloromyotomy.
We therefore did an international, multicentre, double-blind, randomised controlled trial to compare laparoscopic and open pyloromyotomy for the treatment of pyloric stenosis.
Section snippets
Trial design and participants
This study was done at six centres (table 2) from June, 2004, to May, 2007, and coordinated from the Institute of Child Health (London, UK). Ethical approval was obtained from the local research ethics committee in every institution before recruitment. Infants were randomly assigned to laparoscopic or open pyloromyotomy, and standardised protocols were used for anaesthesia, postoperative analgesia, and feed. The study was done in accordance with published guidelines24 and is reported in
Results
Figure 2 shows the trial profile and table 3 the demographic and clinical characteristics of patients at enrolment.
Analysis of the primary outcomes showed that, after laparoscopic pyloromyotomy, infants achieved full enteral feed more quickly and were discharged earlier than those undergoing open pyloromyotomy (table 4 and figure 3). To determine whether this difference was apparent soon after surgery, the time at which the first full enteral feed was tolerated without substantial vomiting was
Discussion
With standardised treatments to reduce potential bias between groups, time to achieve full enteral feed and to discharge after laparoscopic pyloromyotomy were significantly reduced compared with those after open pyloromyotomy. We chose these as primary outcomes because any difference in these measures between treatment groups would be of clinical importance and could determine operative approach. Our decision to analyse both was due to factors additional to feeding tolerance, such as wound
References (35)
- et al.
Extramucosal pyloromyotomy by laparoscopy
J Pediatr Surg
(1991) Laparoscopic pyloromyotomy
Semin Pediatr Surg
(1998)- et al.
Laparoscopic extramucosal pyloromyotomy versus open pyloromyotomy for infantile hypertrophic pyloric stenosis: which is better?
J Pediatr Surg
(1999) - et al.
Laparoscopic pyloromyotomy for infantile hypertrophic pyloric stenosis: report of 11 cases
J Pediatr Surg
(1995) - et al.
Comparison of outcomes after laparoscopic and open pyloromyotomy at a high-volume pediatric teaching hospital
J Pediatr Surg
(2006) - et al.
A comparison of laparoscopic and open pyloromyotomy at a teaching hospital
J Pediatr Surg
(2002) - et al.
The learning curve for aparoscopic pyloromyotomy
J Pediatr Surg
(1997) - et al.
Laparoscopic pyloromyotomy for hypertrophic pyloric stenosis: a prospective, randomized controlled trial
J Pediatr Surg
(2007) - et al.
Comparison of the incidence of complications in open and laparoscopic pyloromyotomy: a concurrent single institution series
J Pediatr Surg
(2004) - et al.
Pyloromyotomy: a comparison of laparoscopic, circumumbilical, and right upper quadrant operative techniques
J Am Coll Surg
(2005)
Evaluation of surgical approaches to pyloromyotomy: a single-center experience
J Pediatr Surg
Ghosts in the machine: a multi-institutional comparison of laparoscopic and open pyloromyotomy
J Pediatr Surg
Early experience with laparoscopic pyloromyotomy for infantile hypertrophic pyloric stenosis
J Pediatr Surg
Zur operation der angeborenen pylorus stenose
Med Klin
Pyloromyotomy: comparison between laparoscopic and open surgical techniques
J Laparoendosc Surg
Is laparoscopic pyloromyotomy superior to open surgery?
Surg Endosc
Laparoscopic pyloromyotomy: redefining the advantages of a novel technique
J Soc Laparoend Surg
Cited by (161)
Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis—A Systematic Review and Meta-Analysis
2022, Journal of Surgical ResearchCitation Excerpt :For this reason, both studies were classified as high risk for selection bias. The remaining five studies described appropriate methods for randomly allocating participants (low risk for selection bias).19,26-28,30 Among the included studies, two of seven applied appropriate blinding strategies for avoiding performance bias.19,27
Laparoscopic versus open pyloromyotomies: Outcomes and disparities in pyloric stenosis
2022, Journal of Pediatric SurgeryCitation Excerpt :Laparoscopy in pyloromyotomy has been slower to be accepted widely due to early studies that showed higher rates of mucosal perforation [11]. However, more recently several studies have reported that laparoscopy [11–14] has lower rates of complications. Complications are rare in laparoscopic and open pyloromyotomy.
Recurrent hypertrophic pyloric stenosis in an 8-week-old
2022, Journal of Pediatric Surgery Case ReportsPostoperative Opioid Analgesia Impacts Resource Utilization in Infants Undergoing Pyloromyotomy
2020, Journal of Surgical Research