Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|