Clinical Trial: Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

Brief 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 Summary: 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.
Sponsor: Children's Mercy Hospital Kansas City

Current Primary Outcome: Operative Time

Original Primary Outcome:

Current Secondary Outcome:

  • Time to full feeds
  • Length of hospitalization
  • Pain medication requirements
  • Emesis episodes
  • Complications


Original Secondary Outcome:

Information By: Children's Mercy Hospital Kansas City

Dates:
Date Received: September 12, 2005
Date Started: April 2003
Date Completion:
Last Updated: April 5, 2007
Last Verified: September 2005