Transit Bipartition After Sleeve Gastrectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital das Clínicas de Ribeirão Preto
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Liver cirrhosis;
Absence of willingness to undergo a new surgical procedure.
Trial design
Design model
Single group
Treatments tested in this trial
Conversion to Intestinal Transit Bipartition
Procedure/SurgeryRevisional 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Transit Bipartition After Sleeve GastrectomyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to 6 months after transit bipartitionSecondary outcomes
1
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.
Time frame
Baseline to 6 months2
Change in DeMeester Score
Change from baseline to 6 months in the composite DeMeester score derived from 24-hour ambulatory esophageal pH monitoring. The score incorporates six parameters: percentage of total recording time with esophageal pH below 4, percentage of upright time with pH below 4, percentage of supine time with pH below 4, total number of reflux episodes, number of reflux episodes lasting longer than 5 minutes, and duration of the longest reflux episode. The DeMeester score is a continuous composite index with no predefined minimum or maximum value. Higher scores indicate greater pathological esophageal acid exposure and therefore a worse outcome. A score greater than 14.72 is conventionally considered abnormal. Change will be calculated as the 6-month score minus the baseline score; negative values indicate improvement, whereas positive values indicate worsening.
Time frame
Baseline to 6 months3
Change in Esophageal Acid Exposure
Change in percentage of monitoring time with esophageal pH below 4.
Time frame
Baseline to 6 months4
Route-Specific Gastric Transit
Scintigraphic distribution of the solid meal through pyloric/duodenal and gastroileal routes
Time frame
6 monthsOther outcomes
1
Gastroileal Anastomotic Caliber
Endoscopically measured mature diameter and patency of the gastroileal anastomosis
Time frame
12 months2
Adverse Events and Complications
Incidence and description of surgery-related, examination-related, and follow-up adverse events and complications.
Time frame
Procedure through 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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