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

Influence of Argon Plasma Coagulation on weight loss in patients with weight regain after Bariatric Y Roux Surgery: Randomized clinical trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-7p4dtq
Enrollment
Unknown
Registered
2020-09-17
Start date
2020-02-07
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric surgery

Interventions

Four groups (10 randomized individuals in each group): Experimental groups: argon plasma coagulation and 7-day liquid diet
argon plasma coagulation and 20-day liquid diet
Control groups: endoscopy with phantom procedure and 7-day liquid diet
and endoscopy with phantom procedure and a 20-day liquid diet. Argon plasma coagulation: Argon plasma application over the entire circumference of the gastrojejunal anastomosis by means of an endoscop
Procedure/surgery
Other
D01.268.613.050

Sponsors

Faculdade de Medicina de Botucatu
Lead Sponsor
Mariana Bordinhon de Moraes
Collaborator
Sérgio Alberto Rupp de Paiva
Collaborator
Luiz Eduardo Naresse
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Brazil

Contacts

Public Contactmariana moraes

Faculdade de Medicina de Botucatu

mari_bordinhon@hotmail.com14998779108

Outcome results

None listed

Source: REBEC (via WHO ICTRP)