Influence of Argon Plasma Coagulation on weight loss in patients with weight regain after Stomach Reduction Surgery

Phase 1

Recruiting

• Conditions: Obesity; Bariatric surgery; C18.654.726.500; E02.570.500.062

• Registration Number: RBR-7p4dtq
• Lead Sponsor: Faculdade de Medicina de Botucatu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Individuals over 18 years of age with a history of regain weight of at least 10% of their weight after bariatric Y-Roux surgery performed for at least 18 months

Exclusion Criteria

Individuals with impossibility of endoscopic handling in the gastrointestinal tract; verification of anastomosis diameter less than 2.0 cm; severe organic pathologies, such as neoplasms, chronic obstructive pulmonary disease, renal failure, heart failure and cirrhosis; pregnancy or intention to become pregnant in the 12 months after the CPA procedure; inability to return to clinical care after the CPA procedure; and non-adherence to medical treatment.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of weight loss measured by weight in kg, 3 and 6 months after the procedure with argon plasma or phantom

Secondary Outcome Measures

Name	Time	Method
Body composition, measured through measurements made by the adipometer and by means of an electrical bioimpedance device, 3 and 6 months after the procedure with argon plasma or phantom ;Dietary intake, measured through a 24-hour recall 3 and 6 months after the procedure with argon plasma or phantom ;Gastrointestinal symptoms measured through self-report, 3 and 6 months after the procedure with argon plasma or phantom