Study Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of ligamentum teres cardiopexy on incidence of de Novo GERD.

Detailed Description
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Laparoscopic Sleeve Gastrectomy (LSG) is now the most commonly performed bariatric surgery world wide. The results of LSG on outcomes of GERD are conflicting. It has been reported to increase the severity of pre existing GERD and also to cause new onset GERD in considerable number of patients. In this study the effect of adding a novel procedure i.e. ligamentum teres cardiopexy,(LTC) to regular LSG on occurence of de Novo GERD will be investigated. de Novo GERD has been found to occur in 20% of cases post LSG. This study is a randomized, prospective, parallel group, controlled trial to compare the effect of LSG versus LSG with LTC on occurence of de Novo GERD. This is a single center based trial, being conducted in GEM hospital and research center, Coimbatore, Tamil Nadu, India. The trial has been approved by GEM research ethics committee. Investigators are planning to enroll patients who are not having any objective or subjective evidence of GERD. The participants will be optimized as per institutional bariatric surgery protocol. After complete evaluation and optimization, participants will be randomized by computer generated random numbers into either LSG or LSG with LTC group. The demographic data, preoperative GERD - Q scores, 24 hour pH study, intra operative details will be recorded. Post operative details during each follow up will be recorded, which will include excess weight loss, GERD - Q scores. At 6 months follow up repeat 24 hour pH study will be done to assess the status of GERD objectively. The trial duration is expected to be of 1 year where in investigators will be recruiting patients for 6 months.

Official Title
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Randomized Controlled Trial Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG

Conditions
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GERD

Intervention / Treatment
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* Procedure: laparoscopic sleeve gastrectomy
* Procedure: ligamentum teres cardiopexy with sleeve gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: candidate for bariatric surgery according to IFSO - APC guidelines No evidence (objective and subjective) of GERD Exclusion Criteria: Presence of GERD either by history or by 24 hr pH study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LSG<br>This group will receive standard laparoscopic sleeve gastrectomy | Procedure: laparoscopic sleeve gastrectomy<br>* Comparator arm - will receive standard laparoscopic sleeve gastrectomy<br>|
| Experimental: LSG with LTC<br>This group will receive LSG along with the novel LTC procedure | Procedure: ligamentum teres cardiopexy with sleeve gastrectomy<br>* experimental arm - Ligamentum teres will be divided from umbilicus to up to umbilical fissure. The ligament will then be wrapped around lower esophagus and sutured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD | Subjective (Gastroesophageal Reflux Disease questionnaires - GERD - Q) and objective (24 hour pH study) measurement of occurence of GERD will be done GERD - Q - Score 0-2 denotes no GERD. Score more than or equal to 3 indicates presence of GERD 24 hr pH study - Demeester score more than 14.7 is indicative of presence of GERD | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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de Novo GERD