Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652336
Status:
UNKNOWN
Last Update Posted:
2020-12-21
First Post:
2020-11-26
Brief Title:
Study Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG
Sponsor:
GEM Hospital Research Center
Organization:
GEM Hospital Research Center
Study Overview
Official Title:
Randomized Controlled Trial Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie ligamentum teres cardiopexyLTC 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
In this study the effect of adding a novel procedure ie ligamentum teres cardiopexyLTC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None