Roux-en-Y Gastric Bypass: Clinical Trial
NCT04649619 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2020-12-02
Summary
The present study aims to describe the results of a modified gastric bypass surgery to ensure endoscopic access to the excluded remaining stomach, as well as to monitor the clinical conditions of comorbidities and the patient's quality of life, since associated complications can be found to the excluded stomach, such as: bile reflux, gastritis and / or gastric and duodenal ulcer, H. pylori infection, bleeding, gastric polyps and the possibility of gastric cancer in patients undergoing RYGB (Roux-en-Y gastric bypass), with one of the probable factors being the occurrence reflux of the duodenal content into the excluded portion of the stomach.
In this sense, based on technical concepts of an established surgical procedure, the RYGB, the present project is not a proposal for a new procedure, but an adaptation of an existing technique. The proposal of the present study is about adaptations in RYGB surgery, which will enable endoscopic access to the remaining stomach, through the creation of a gastric communication.
Conditions
Interventions
- PROCEDURE
-
GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERY
Roux-en-Y gastric bypass: Stapling and reduction of the gastric chamber of approximately 18 cm, followed by anastomosis with a deviated bowel, and another bowel anastomosis with a bowel in a lower portion, for deviation of biliopancreatic secretions. Maintenance of a gastro-gastric communication of approximately 1 cm between the functional gastric pouch and the excluded stomach for endoscopic access.
Sponsors & Collaborators
-
Hospital Estadual Geral de Goiânia Dr. Alberto Rassi
collaborator UNKNOWN -
Paulo Reis Esselin de Melo
lead OTHER
Principal Investigators
-
Paulo Reis Esselin de Melo · Hospital Geral de Goiânia
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-18
- Primary Completion
- 2021-02-10
- Completion
- 2021-04-29
Countries
- Brazil
Study Locations
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