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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APC intervention | Experimental | 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. |
|
| Control | No Intervention | Patients are treated according to standard care (multidisciplinary care). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argon plasma coagulation | Procedure | On D0, in the operating room, argon plasma coagulation will be performed around the perimeter of the anastomosis for a period of 5 to 10 min under general anesthesia. The removal of the catheter and the endoscope will be carried out under control. Patients will be kept under surveillance the night following the procedure. A liquid diet will be prescribed for 10 days. The follow-up will be carried out on an outpatient basis with a control endoscopy at 2 months, followed by a new procedure in the event of an anastomosis larger than 1.5 cm. A new endoscopic check will be carried out at 4 months if an argon plasma coagulation was performed during the previous check, with a third and last argon plasma coagulation if an anastomosis of more than 1.5 cm persists. The number of procedures will therefore be a maximum of 3. A control endoscopy will be performed at one year for the final control of the anastomosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the percentage change (loss) in excess weight from Day 0 to Month 12 between the 2 arms | The percentage of excess weight loss (PEP%) will be measured according to the formula: PEP% = weight loss in kg * 100 / excess of initial weight. The initial excess weight is defined as the baseline weight - ideal weight. | Day 0 (before the intervention) and Months 12 (one year after Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BELLEC-FAGOT | Contact | 0637110376 | mbellecfagot@vivalto-sante.com | |
| Adrien STERKERS, MD | Contact | asterkers@vivalto-sante.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHP Saint-Grégoire | Recruiting | Saint-Grégoire | 35760 | France |
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| ID | Term |
|---|---|
| D057908 | Argon Plasma Coagulation |
| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| D002425 | Cautery |
| D013812 | Therapeutics |
| D006489 | Hemostatic Techniques |
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|
| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006488 | Hemostasis, Surgical |