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

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

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

Study Overview

• Status: Unknown
• Conditions: GERD
• Intervention / Treatment: Procedure: laparoscopic sleeve gastrectomy; Procedure: ligamentum teres cardiopexy with sleeve gastrectomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PRAKHAR GUPTA; Phone Number: +919582438389; Email: mailto.guptaprakhar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LSG; This group will receive standard laparoscopic sleeve gastrectomy	Procedure: laparoscopic sleeve gastrectomy; Comparator arm - will receive standard laparoscopic sleeve gastrectomy
Experimental: LSG with LTC; This group will receive LSG along with the novel LTC procedure	Procedure: ligamentum teres cardiopexy with sleeve gastrectomy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GEM Hospital & Research Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 10, 2020
• Primary Completion (Anticipated): May 10, 2021
• Study Completion (Anticipated): December 10, 2021

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: de Novo GERD
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: GHC-16-OCT/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No