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

GEM Hospital & Research Center

Status: Unknown

Conditions: GERD

Treatments: Procedure: laparoscopic sleeve gastrectomy; Procedure: ligamentum teres cardiopexy with sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04652336

GHC-16-OCT/2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

LSG

Active Comparator group

Description:

This group will receive standard laparoscopic sleeve gastrectomy

Treatment:

Procedure: laparoscopic sleeve gastrectomy

LSG with LTC

Experimental group

Description:

This group will receive LSG along with the novel LTC procedure

Treatment:

Procedure: ligamentum teres cardiopexy with sleeve gastrectomy