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

GERD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04652336
• Other study ID #: GHC-16-OCT/2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: December 10, 2021

Study information

• Verified date: December 2020
• Source: GEM Hospital & Research Center
• Contact: PRAKHAR GUPTA
• Phone: +919582438389
• Email: mailto.guptaprakhar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Procedure:
• laparoscopic sleeve gastrectomy
Comparator arm - will receive standard laparoscopic sleeve gastrectomy
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GEM Hospital & Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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