Clinical trial

Transit Bipartition After Sleeve Gastrectomy

Opening soon · Not applicable · 1 countries · Registry ID NCT07728682

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight, Gastroesophageal Reflux (GERD), Weight Recurrence, Bariatric Surgery

Full registry 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.

Treatments and study arms

Conversion to Intestinal Transit Bipartition

Procedure

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.

Primary outcomes

Change in Solid-Meal Gastric Emptying Half-Time (T½)Baseline to 6 months after transit bipartition

Within-participant change in gastric emptying half-time, in minutes, measured by standardized solid-meal gastric emptying scintigraphy. The measure is calculated as the 6-month postoperative T½ minus the preoperative baseline T½.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital das Clínicas de Ribeirão Preto🇧🇷 Ribeirão Preto, São Paulo, Brazil

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Fabiana CP Valera, MD PhDContact

Email · Call +5516981548312