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

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.

• Procedure: esophageal stitches during fundoplication
  placement of esophageal stitches with fundoplication
  Other Name: crural stitches.
• Procedure: no esophageal stitches placed during fundoplication
  no esophageal stitches are placed during the fundoplication procedure
  Other Name: crural stitches

• Active Comparator: with esophageal stitches
  fundoplication with crural stitches
  Intervention: Procedure: esophageal stitches during fundoplication
• Experimental: without esophageal stitches
  fundoplication without crural stitches.
  Intervention: Procedure: no esophageal stitches placed during fundoplication

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)