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Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

Primary Purpose

Hypertrophic Pyloric Stenosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic pyloromyotomy
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Pyloric Stenosis focused on measuring Pyloric Stenosis, Laparoscopy, Idiopathic Hypertrophic Pyloric Stenosis

Eligibility Criteria

undefined - 12 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Mercy Hospital

Outcomes

Primary Outcome Measures

Operative Time

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
April 5, 2007
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT00195949
Brief Title
Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis
Official Title
Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Pyloric Stenosis
Keywords
Pyloric Stenosis, Laparoscopy, Idiopathic Hypertrophic Pyloric Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Laparoscopic pyloromyotomy
Primary Outcome Measure Information:
Title
Operative Time
Secondary Outcome Measure Information:
Title
Time to full feeds
Title
Length of hospitalization
Title
Pain medication requirements
Title
Emesis episodes
Title
Complications

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Ostlie, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas CIty
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

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