Status:
COMPLETED
Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Reflux
Eligibility:
All Genders
1-7 years
Phase:
NA
Brief Summary
This is a prospective trial of the utility of esophageal stitches during fundoplication. The hypothesis is that recurrence rate may be different with or without the esophageal stitches.
Detailed Description
This will be a single center, prospective randomized clinical trial involving patients who require an operation for gastroesophageal reflux disease. This is intended to be a definitive study. All pati...
Eligibility Criteria
Inclusion
- Patients less than 7 years of age requiring fundoplication for gastroesophageal reflux disease who are considered good laparoscopic candidates by the staff surgeon will be considered candidates.
Exclusion
- Hiatal hernia demonstrated on preoperative contrast study, computed tomography, endoscopy, or intraoperative findings.
- Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
- Prior operation for congenital diaphragmatic hernia
- 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 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01509352
Start Date
February 1 2010
End Date
March 1 2015
Last Update
January 26 2017
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108