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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT01509352
Study type Interventional
Source Children's Mercy Hospital Kansas City
Contact
Status Completed
Phase N/A
Start date February 2010
Completion date March 2015

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