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NCT07728682
Transit Bipartition After Sleeve Gastrectomy
Conditions: Obesity & Overweight, Gastroesophageal Reflux (GERD), Weight Recurrence, Bariatric Surgery
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Hospital das Clínicas de Ribeirão Preto
Location: Hospital das Clínicas de Ribeirão Preto Ribeirão Preto São Paulo
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.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older;
* Previous sleeve gastrectomy for the treatment of obesity;
* Follow-up at the HCRP gastrosurgery/bariatric surgery outpatient clinic through 2026;
* Clinical evaluation supporting revisional conversion to intestinal transit bipartition;
* Willingness to undergo the new surgical procedure and provide written informed consent.
Exclusion Criteria:
* Liver cirrhosis;
* Absence of willingness to undergo a new surgical procedure.
Source: ClinicalTrials.gov (NCT07728682). StuddyBuddy aggregates publicly available trial information.