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

NCT ID: NCT04652336

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2021-12-10

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.

Conditions

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GERD

Keywords

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de Novo GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LSG

This group will receive standard laparoscopic sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Comparator arm - will receive standard laparoscopic sleeve gastrectomy

LSG with LTC

This group will receive LSG along with the novel LTC procedure

Group Type EXPERIMENTAL

ligamentum teres cardiopexy with sleeve gastrectomy

Intervention Type PROCEDURE

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.

Interventions

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laparoscopic sleeve gastrectomy

Comparator arm - will receive standard laparoscopic sleeve gastrectomy

Intervention Type 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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GEM Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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PRAKHAR GUPTA

Role: CONTACT

Phone: +919582438389

Email: [email protected]

Other Identifiers

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GHC-16-OCT/2020

Identifier Type: -

Identifier Source: org_study_id