A laparoscopic approach to pyloromyotomy for infantile pyloric stenosis has gained popularity but its effectiveness remains unproven.
Dr Nigel Hall compared outcomes after open or laparoscopic pyloromyotomy for the treatment of pyloric stenosis.
The research team undertook a multicenter international, double-blind, randomized, controlled trial between 2004 and 2007, across 6 tertiary paediatric surgical centers.
The team randomized 180 infants to open or laparoscopic pyloromyotomy with minimisation for age, weight, gestational age at birth, bicarbonate at initial presentation, feeding type, preoperative duration of symptoms, and trial center.
Infants with a diagnosis of pyloric stenosis were eligible.
|Postoperative length of stay was 34 hours in the laparoscopic groups|
Primary outcomes were time to achieve full enteral feed and duration of postoperative recovery.
The researchers aimed to recruit 200 infants, however, the data monitoring and ethics committee recommended halting the trial before full recruitment because of treatment benefit in a group at interim analysis.
Participants, parents, and nursing staff were unaware of treatment.
Data were analyzed on an intention-to-treat basis with regression analysis.
Time to achieve full enteral feeding in the open pyloromyotomy group was 23 hours versus 19 hours in the laparoscopic group.
The team noted that postoperative length of stay was 44 hours versus 34 hours in the open and laparoscopic groups, respectively.
Postoperative vomiting, and intra-operative and postoperative complications were similar between the 2 groups.
Dr Hall’s team concluded, “Both open and laparoscopic pyloromyotomy are safe procedures for the management of pyloric stenosis.”
“However, laparoscopy has advantages over open pyloromyotomy, and we recommend its use in centers with suitable laparoscopic experience.”