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

Not Applicable

Completed

• Conditions: Reflux
• Interventions: Procedure: esophageal stitches during fundoplication; Procedure: no esophageal stitches placed during fundoplication

• Registration Number: NCT01509352
• Lead Sponsor: Children's Mercy Hospital Kansas City

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 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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-13
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with esophageal stitches	esophageal stitches during fundoplication	fundoplication with crural stitches
without esophageal stitches	no esophageal stitches placed during fundoplication	fundoplication without crural stitches.

Primary Outcome Measures

Name	Time	Method
hiatal herniation	4 year follow-up

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States