Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels

Study Overview
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Brief Summary
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Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. In an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. Patients were recruited for this trial and short-term results had been already published in a national journal. The investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.

Official Title
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Randomized Clinic Trial of Total Fundoplication and Fundal Mobilization With or Without Division of Short Gastric Vessels: Long-Term Endoscopic Evaluation

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Procedure: Lap Nissen fundoplication with division of short gastric vessels
* Procedure: Laparoscopic Nissen fundoplication without division of short gastric vessels


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: objective gastroesophageal reflux in adults Exclusion Criteria: esophageal motility disorder hard stenosis previous antireflux surgery

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>dividing short gastric vessels | Procedure: Lap Nissen fundoplication with division of short gastric vessels<br>* Dividing short gastric vessels<br>* Other names: Fundoplication, Gastroesophageal Reflux,Surgery;|
| Active Comparator: 2<br>non-dividing short gastric vessels | Procedure: Laparoscopic Nissen fundoplication without division of short gastric vessels<br>* non-dividing short gastric vessels<br>* Other names: Fundoplication, Gastroesophageal Reflux,Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels. |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term clinical and endoscopic outcome |  | 8-10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fundoplication, gastroesophageal reflux, gastric vessels, surgery