Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

Hypertrophic Pyloric Stenosis Clinical Trial

Official title:

Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195949
• Other study ID #: 03-01-004
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 5, 2007
• Start date: April 2003
• Est. completion date: February 2006

Study information

• Verified date: September 2005
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Gastric Outlet Obstruction
• Hypertrophic Pyloric Stenosis
• Hypertrophy
• Pyloric Stenosis

Intervention

Procedure:
• Laparoscopic pyloromyotomy

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas CIty	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative Time
Secondary	Time to full feeds
Secondary	Length of hospitalization
Secondary	Pain medication requirements
Secondary	Emesis episodes
Secondary	Complications