Gastric Recalibration After Endoscopic Sleeve Gastroplasty

Status Recruiting

Clinical Trial Summary

Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revision". This study will assess the benefits and costs of a revision during the follow-up endoscopy.

Clinical Trial Description

Obesity is a health dilemma with an increased risk of premature death. Bariatric surgery is considered to be the most effective and durable treatment for morbid obesity as compared to other available options. However, only the most severe cases, namely class III or class II patients with obesity-related comorbidities fit the criteria for bariatric surgical interventions and are offered these options. Endoscopic sleeve gastroplasty (ESG) is a restrictive procedure based on the tubulization and shortening of the stomach, achieved by means of multiple full-thickness sutures applied endoscopically. ESG offers the possibility to obtain results (weight loss, improvement of comorbidities and quality of life) comparable to conventional surgery while reducing the risk of complications. One of the major advantages of this technique is that it does not make irreversible changes to gastric anatomy and function and can be repeated overtime if needed placing additional sutures. ESG appearance might be subject to changes overtime. In fact, depending on the sutures' integrity, the gastroplasty can be regarded as tight, partially open or completely open. Very little data currently exists in the literature on the effectiveness of endoscopic "revision" with the placement of additional sutures on weight loss and its impact on co-morbidities. In order to objectively assess the benefits and costs of a revision during the follow-up endoscopy patients who present a TWL <10% or a BMI greater than 30 at 6 months from the primary ESG, will be randomized into 2 groups: a "Revision" group in which a revision will be performed systematically in the event of suture disruption at the control EGD, and a "Control" group which will only benefit of a control endoscopy regardless of the state of the gastroplasty. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04945473
Study type	Interventional
Source	IHU Strasbourg
Contact	Pierre GOEPFERT
Phone	0390413646
Email	pierre.goepfert@ihu-strasbourg.eu
Status	Recruiting
Phase	N/A
Start date	July 13, 2021
Completion date	September 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Gastric Recalibration After Endoscopic Sleeve Gastroplasty — ESG-IRM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms