NCT01509352

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 1 Day – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Reflux

Interventions

Type	Name	Description
PROCEDURE	esophageal stitches during fundoplication	placement of esophageal stitches with fundoplication
PROCEDURE	no esophageal stitches placed during fundoplication	no esophageal stitches are placed during the fundoplication procedure

Timeline

• Start date: 2010-02-01
• Primary completion: 2015-02-01
• Completion: 2015-03-01
• First posted: 2012-01-13
• Last updated: 2017-01-26

Locations

1 site across 1 country: United States