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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07728682). StuddyBuddy aggregates publicly available trial information.