Status:
COMPLETED
Necessity of Esophageal Dissection During Laparoscopic Fundoplication
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
University of Alabama at Birmingham
Conditions:
Gastroesophageal Reflux Disease
Hiatal Hernia
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
This study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children.
Detailed Description
This will be a 2-center, prospective randomized clinical trial involving patients who require an operation for gastroesophageal reflux disease. This is intended to be a definitive study. All patients ...
Eligibility Criteria
Inclusion
- Under 18 years of age
- Gastroesophageal Reflux Disease
Exclusion
- Hiatal hernia demonstrated on preoperative contrast study, computed tomography or endoscopy
- Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
- Prior operation for congenital diaphragmatic hernia
- Patient or family circumstance that will create difficulty attaining one-year follow-up (e.g. referral from distance or anticipated relocation of family)
- Patients not considered laparoscopic candidates by the staff surgeon or anesthesiologist (e.g. carbon dioxide retaining lung disease, congenital heart disease, or complex previous abdominal operations)
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00287612
Start Date
February 1 2006
End Date
August 1 2009
Last Update
September 22 2009
Active Locations (2)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108