Transit Bipartition After Sleeve Gastrectomy

NCT07728682 | Not Yet Recruiting

• 2 other identifiers: HCRP-BTT-2026-01CAAE 95147126.1.0000.5440
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sleeve gastrectomy; transit bipartition; gastric emptying; scintyigraphy; T1/2; DeMeester score; gastroileal anastomosis; GLP-1; fecal elastase

Outcome Measures

Primary Outcomes (1)

• Change in Solid-Meal Gastric Emptying Half-Time (T½)

  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.

  Baseline to 6 months after transit bipartition

Secondary Outcomes (8)

• Change in GERD-HRQL Score

  Baseline to 6 months

• Change in DeMeester Score

  Baseline to 6 months

• Change in Esophageal Acid Exposure

  Baseline to 6 months

• Route-Specific Gastric Transit

  6 months

• Change in GLP-1 AUC

  Baseline to 6 months

Other Outcomes (2)

• Gastroileal Anastomotic Caliber

  12 months

• Adverse Events and Complications

  Procedure through 12 months

Study Arms (1)

Transit Bipartition After Sleeve Gastrectomy

EXPERIMENTAL

Participants with previous sleeve gastrectomy undergo revisional conversion to intestinal transit bipartition and are followed for 12 months.

Procedure: Conversion to Intestinal Transit Bipartition

Interventions

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.

Transit Bipartition After Sleeve Gastrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Liver cirrhosis; Absence of willingness to undergo a new surgical procedure.

Sponsors & Collaborators

• Hospital das Clínicas de Ribeirão Preto: lead

Study Sites (1)

Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

MeSH Terms

Conditions

Obesity; Overweight; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Wilson Salgado Jr, MD PhD

  Hospital Estadual de Ribeirão Preto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilson Salgado Jr, MD, PhD

CONTACT

+5516981564846; wsalgado@fmrp.usp.br

Ana BT Soares, MD

CONTACT

+5516981188439; ana.beatriz.soares@alumni.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants undergo revisional conversion from sleeve gastrectomy to intestinal transit bipartition and are assessed before and after surgery.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): August 2, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)