NCT04652336

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: GEM Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• GERD

Interventions

Type	Name	Description
PROCEDURE	laparoscopic sleeve gastrectomy	Comparator arm - will receive standard laparoscopic sleeve gastrectomy
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.

Timeline

• Start date: 2020-12-10
• Primary completion: 2021-05-10
• Completion: 2021-12-10
• First posted: 2020-12-03
• Last updated: 2020-12-21