Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-02-28

Brief Summary

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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

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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

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Hypertrophic Pyloric Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Laparoscopic pyloromyotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Daniel J Ostlie, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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03-01-004

Identifier Type: -

Identifier Source: org_study_id