Transit Bipartition After Sleeve Gastrectomy
NCT07728682 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-08-03
Summary
This prospective, single-center study will evaluate adults undergoing revisional conversion from sleeve gastrectomy to intestinal transit bipartition. Forty participants will complete clinical, endoscopic, physiological, metabolic, hormonal, imaging, and stool assessments before surgery and during follow-up. The primary outcome is the within-participant change in solid-meal gastric emptying half-time (T½), measured by standardized scintigraphy from baseline to 6 months. Secondary and exploratory outcomes include reflux symptoms, DeMeester score and acid exposure, route-specific gastric transit, GLP-1 and ghrelin responses, glucose metabolism, fecal elastase, gut microbiota, body-weight trajectory, comorbidities, gastroileal anastomotic caliber, and safety.
Conditions
- Obesity & Overweight
- Gastroesophageal Reflux (GERD)
- Weight Recurrence
- Bariatric Surgery
Interventions
- PROCEDURE
-
Conversion to Intestinal Transit Bipartition
Revisional surgery creating a side-to-side gastroileal anastomosis, planned at approximately 4 cm, and a distal side-to-side ileoileal anastomosis while preserving the pyloric and duodenal route. Surgery is planned laparoscopically; open conversion or additional gastric resection may be performed when clinically indicated.
Sponsors & Collaborators
-
Hospital das Clínicas de Ribeirão Preto
lead OTHER
Principal Investigators
-
Wilson Salgado Jr, MD PhD · Hospital Estadual de Ribeirão Preto
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-02
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
Countries
- Brazil
Study Locations
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