- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00195949
Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis
April 5, 2007 updated by: Children's Mercy Hospital Kansas City
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Kansas CIty, Missouri, United States, 64108
- Children's Mercy Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Operative Time
|
Secondary Outcome Measures
Outcome Measure |
---|
Complications
|
Time to full feeds
|
Length of hospitalization
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Pain medication requirements
|
Emesis episodes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel J Ostlie, MD, Children's Mercy Hospital Kansas City
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
April 6, 2007
Last Update Submitted That Met QC Criteria
April 5, 2007
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-01-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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