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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Reflux

Intervention / Treatment
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* Procedure: esophageal stitches during fundoplication
* Procedure: no esophageal stitches placed during fundoplication


Participation Criteria
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Eligibility Criteria
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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: Hiatal hernia demonstrated on preoperative contrast study, computed tomography, endoscopy, or intraoperative findings. Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy) Prior operation for congenital diaphragmatic hernia 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)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with esophageal stitches<br>fundoplication with crural stitches | Procedure: esophageal stitches during fundoplication<br>* placement of esophageal stitches with fundoplication<br>* Other names: crural stitches.;|
| Experimental: without esophageal stitches<br>fundoplication without crural stitches. | Procedure: no esophageal stitches placed during fundoplication<br>* no esophageal stitches are placed during the fundoplication procedure<br>* Other names: crural stitches;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hiatal herniation |  | 4 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fundoplication, gastric reflux