Transit Bipartition After Sleeve Gastrectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conversion to Intestinal Transit Bipartition.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight, Gastroesophageal Reflux (GERD), Weight Recurrence, Bariatric Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical, Metabolic, and Physiological Evaluation of Conversion From Sleeve Gastrectomy to Intestinal Transit Bipartition
Overview
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.
Detailed description
Patients previously undergoing sleeve gastrectomy and followed at the bariatric/gastrosurgery clinic of Hospital das Clínicas de Ribeirão Preto will be enrolled consecutively after informed consent. Baseline assessments include medical-record review, anthropometry, GERD-HRQL, upper gastrointestinal endoscopy, high-resolution esophageal manometry, 24-hour esophageal pH monitoring, CT gastric volumetry, solid-meal gastric emptying scintigraphy, metabolic and hormonal testing, and stool collection for microbiota and fecal elastase analyses. Transit bipartition will create a side-to-side gastroileal anastomosis and a distal side-to-side ileoileal anastomosis while preserving pyloric and duodenal transit. Selected paired assessments will be repeated at 6 months. Body weight and comorbidities will be followed at 3, 6, 9, and 12 months, and upper gastrointestinal endoscopy will be repeated at 12 months to assess the mature gastroileal anastomosis. The target of 40 participants is expected to provide 34 complete baseline and 6-month T½ pairs after allowance for 15% attrition.
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.
Primary outcome measures
- Change in Solid-Meal Gastric Emptying Half-Time (T½) [Time frame: Baseline to 6 months after transit bipartition]
Secondary outcome measures (8)
- Change in GERD-HRQL Score [Time frame: Baseline to 6 months]
- Change in DeMeester Score [Time frame: Baseline to 6 months]
- Change in Esophageal Acid Exposure [Time frame: Baseline to 6 months]
- Route-Specific Gastric Transit [Time frame: 6 months]
- Change in GLP-1 AUC [Time frame: Baseline to 6 months]
- Change in Glycemic Measures [Time frame: Baseline to 6 months]
- Change in Fecal Elastase [Time frame: Baseline to 6 months]
- Change in Body Weight [Time frame: Baseline; 3, 6, 9, and 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Hospital das Clínicas de Ribeirão Preto — Ribeirão Preto
Identifiers
NCT: NCT07728682 · HCRP-BTT-2026-01 · CAAE 95147126.1.0000.5440