RecruitingNot ApplicableNCT04945473

Gastric Recalibration After Endoscopic Sleeve Gastroplasty

Assessment of the Impact of Endoscopic Gastric Revision by Application of Additional Sutures on Weight Loss After Endoscopic Sleeve Gastroplasty in Obese Patients

Sponsor

IHU Strasbourg

Enrollment

100 participants

Start Date

Jul 13, 2021

Study Type

INTERVENTIONAL

Conditions

Morbid Obesity

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

Patients aged 18 to 75
Patients with morbid obesity (BMI≥ 30 with comorbidities or> 40)
Patients with obesity for more than 2 years
Failure of medical treatment of obesity
Patients who may benefit from general anaesthesia
Patient able to participate in all aspects of the study and that agree to comply with all study requirements, for the duration of the study. This includes the availability of reliable transportation and sufficient time to attend all follow-up visits.
Patient able to fully understand the study and ready to give consent to participate to the study.
Patient affiliated to the French social security system

Exclusion Criteria11

Patient with a contraindication to perform an ESG
Patient with a history of previous bariatric, gastric or esophageal surgery.
Patient who initiated medical therapy within the last 3 months, with evidence of weight gain.
Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness.
Patient with unstable and precarious state of health, as determined and assessed by the investigator.
Patient who is pregnant, breastfeeding or of childbearing age and without effective contraception.
Patient in exclusion period (determined by a previous or ongoing study)
Patient under legal protection
Patient under guardianship or curatorship
Patients with a BMI less than 30 at 6 months after ESG. These patients will not be candidate for revision regardless of the randomization group.
Patients with a contraindication to MRI may be included in the study and will follow the "No Imaging" study design.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREEndoscopic placement of additional sutures

A new endoscopic suture will be performed in case of a BMI≥30 or total weight loss (TBWL) less than 10%, and relaxation of gastric tubulization during the regular endoscopic follow-up after 6 months from the ESG. The same endoscopic suture technique of the primary ESG will be applied.