Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

Phase 3

Completed

• Conditions: Hypertrophic Pyloric Stenosis

• Registration Number: NCT00195949
• Lead Sponsor: Children's Mercy Hospital Kansas City

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 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.

Study Timeline

• Study Start: 2003-04
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Completion: 2006-02
• Last Update Submitted: 2007-04-05
• Last Update Posted: 2007-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• All infants less than 12 weeks of age who have undergone surgical consultation and abdominal ultrasound confirming the diagnosis of pyloric stenosis and whose parents have given consent for inclusion in the study.

Exclusion Criteria

• All patients greater than 12 weeks of age, or without parental consent, or without pyloric stenosis will be excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Operative Time

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas CIty, Missouri, United States