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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
placement of esophageal stitches with fundoplication
no esophageal stitches are placed during the fundoplication procedure
Children's Mercy Hospital
Kansas City, Missouri, United States
hiatal herniation
Time frame: 4 year follow-up
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