Transit Bipartition After Sleeve Gastrectomy

N/ANot Yet RecruitingNCT07728682

Hospital das Clínicas de Ribeirão Preto40 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 6 months after transit bipartition

Secondary Outcomes

Change in GERD-HRQL Score

Change from baseline to 6 months in the total score of the validated Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Questionnaire. The questionnaire contains 10 symptom items, each scored from 0 (no symptoms) to 5 (incapacitating symptoms), yielding a total score ranging from 0 to 50. Higher total scores indicate more severe gastroesophageal reflux disease symptoms and worse health-related quality of life. Change will be calculated as the 6-month score minus the baseline score; negative values indicate improvement, whereas positive values indicate worsening. The separate patient satisfaction item (satisfied, neutral, or dissatisfied) is not included in the total score.