Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass (ARG-BP)

Saint-Gregoire Private Hospital Center

Status: Enrolling

Conditions: Bariatric Surgery Candidate

Treatments: Procedure: Argon plasma coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05149105

2020-A02992-37

Details and patient eligibility

About

Among the techniques of bariatric surgery, the gastric Y bypass according to Roux (RYGB) allows greater weight loss and more lasting over time than sleeve gastrectomy and gastric banding. However, around 20% of patients will regain weight within 24 months after surgery. Among the many mechanisms that lead to weight regain, we can mention distension of the gastric pouch and gastro-jejunal anastomosis. A reoperation is then necessary. Argan plasma coagulation intervention (APC) by endoscopy allows to reduce the caliber of the gastro-jejunal anastomosis. The aim of the study is to show the efficacy of APC associated with multidisciplinary medical management and to compare it with multidisciplinary medical management alone in weight regain of patients.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be between 18 and 65 years old.
• Have had a gastric bypass in Y more than 2 years ago
• Have a weight regain of more than 10% of the lowest weight after the first intervention.
• Have benefited from a multidisciplinary medico-psychological reassessment.
• Understand the interest of the study and agree to long-term follow-up.
• Agree to be included in the study and have signed a consent form in a free and informed manner.
• Be affiliated with health insurance.
• For female patients of childbearing potential, have an effective method of contraception

Exclusion criteria

• Presence of a disease unrelated to obesity that is life-threatening.
• Pregnancy or wish to become pregnant within the year.
• "Breastfeeding" patients
• Female patients of childbearing age and unable or unwilling to use an effective method of contraception
• Presence of an unhealed gastric ulcer or stenosis of the gastrointestinal anastomosis
• Presence of a psychiatric pathology compromising the proper understanding of the study or patient under guardianship or guardianship.
• Patient not understanding French or unable to give consent.
• Patient already included in a study or in conflict of interest with this study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

APC intervention

Experimental group

Description:

In addition to multidisciplinary care (standard care), patients benefit from an Argon Plasma Coagulation (APC) intervention at D0. The APC intervention should be repeted at Month 2 and Month 4.

Treatment:

Procedure: Argon plasma coagulation

Control

No Intervention group

Description:

Patients are treated according to standard care (multidisciplinary care).