Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
NCT Number: NCT01509352
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.
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All sexes
Interventional
Not applicable
Kansas City, Missouri, 64108, United States
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 patients will receive the standard operation for reflux: laparoscopic fundoplication. The dissection will be performed by leaving the phrenoesophageal membrane intact in all patients.
One group will undergo laparoscopic fundoplication with 4 esophageal-crural sutures while the other group will not have these placed. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 criteria
placement of esophageal stitches with fundoplication
Other names: crural stitches.
no esophageal stitches are placed during the fundoplication procedure
Other names: crural stitches
Time frame: 4 year follow-up
Children's Mercy Hospital Kansas City
Other
Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication.
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