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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Service de chirurgie digestive et endocrinienne, NHC
RECRUITING
Strasbourg
Contact Information
Primary
Pierre GOEPFERT
pierre.goepfert@ihu-strasbourg.eu
0390413646
Backup
Armelle TAKEDA
armelle.takeda@ihu-strasbourg.eu
0390413608
Time Frame
Start Date: 2021-07-13
Estimated Completion Date: 2026-09
Participants
Target number of participants: 100
Treatments
Experimental: Revision
BMI≥30 or total weight loss (TBWL) \< 10% and relaxation of gastric tubulisation at 6 months after ESG.~Additional stitches will be placed during the follow-up gastroscopy at 6 months.
No_intervention: Without revision
The control gastroscopy will be performed without any additional procedure (no additional stitches).
Related Therapeutic Areas
Sponsors
Leads: IHU Strasbourg

This content was sourced from clinicaltrials.gov

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