Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication
|ClinicalTrials.gov Identifier: NCT01509352|
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : January 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Reflux||Procedure: esophageal stitches during fundoplication Procedure: no esophageal stitches placed during fundoplication||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication.|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||March 2015|
Active Comparator: with esophageal stitches
fundoplication with crural stitches
Procedure: esophageal stitches during fundoplication
placement of esophageal stitches with fundoplication
Other Name: crural stitches.
Experimental: without esophageal stitches
fundoplication without crural stitches.
Procedure: no esophageal stitches placed during fundoplication
no esophageal stitches are placed during the fundoplication procedure
Other Name: crural stitches
- hiatal herniation [ Time Frame: 4 year follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509352
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shawn D St. Peter, MD||Children's Mercy Hospital and Clinics|