Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication

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.

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:

1. Hiatal hernia demonstrated on preoperative contrast study, computed tomography,
endoscopy, or intraoperative findings.

2. Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)

3. Prior operation for congenital diaphragmatic hernia

4. 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)