NCT00195949

Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 12 Weeks
• Healthy volunteers: Not accepted

Summary

Pyloric stenosis is a condition that develops in infants and that leads to an obstruction of the channel going out of the stomach. This study is being performed to determine if there is an advantage to the laparoscopic approach or the open approach for the surgical correction of the enlarged pylorus.

Detailed description

Pyloromyotomy for pyloric stenosis has traditionally been performed via an open technique. With advancements in minimally invasive surgery in infants a laparoscopic approach has been developed. These two approaches have never been critically evaluated with regard to superiority of one technique over the other. This is a prospective randomized trial involving infants with pyloric stenosis. It will enroll 100 patients in each arm (statistical and power analysis was performed by Steve Simon, PhD). Parental consent will be obtained and the patients will be randomized to undergo open or laparoscopic pyloromyotomy. Patient age at diagnosis, electrolyte disturbances at diagnosis, ultrasound findings, operative approach, length of pyloromyotomy, operative times, time to tolerating full feeds, number of emesis episodes, length of hospitalization, operative charges, and hospital charges will be collected for comparison between the groups.

Conditions

• Hypertrophic Pyloric Stenosis

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic pyloromyotomy

Timeline

• Start date: 2003-04-01
• Completion: 2006-02-01
• First posted: 2005-09-20
• Last updated: 2007-04-06

Locations

1 site across 1 country: United States