Bariatric Surgery, Gastroesophageal Reflux (GERD), Obesity & Overweight, Weight Recurrence
Conditions
Keywords
sleeve gastrectomy, transit bipartition, gastric emptying, scintyigraphy, T1/2, DeMeester score, gastroileal anastomosis, GLP-1, fecal elastase
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.
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
PROCEDUREConversion 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.
Sponsors
Hospital das Clínicas de Ribeirão Preto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants undergo revisional conversion from sleeve gastrectomy to intestinal transit bipartition and are assessed before and after surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in GERD-HRQL Score | Baseline to 6 months | 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. |
| Change in DeMeester Score | Baseline to 6 months | 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. |
| Change in Esophageal Acid Exposure | Baseline to 6 months | Change in percentage of monitoring time with esophageal pH below 4. |
| Route-Specific Gastric Transit | 6 months | Scintigraphic distribution of the solid meal through pyloric/duodenal and gastroileal routes |
| Change in GLP-1 AUC | Baseline to 6 months | Change in postprandial hormone area under the concentration-time curve from 0 to 180 minutes. |
| Change in Glycemic Measures | Baseline to 6 months | Change in fasting glucose, HbA1c |
| Change in Fecal Elastase | Baseline to 6 months | Change in fecal elastase concentration |
| Change in Body Weight | Baseline; 3, 6, 9, and 12 months | Change in measured body weight at each scheduled postoperative visit. |
Countries
Brazil
Contacts
CONTACTWilson Salgado Jr, MD, PhD
CONTACTAna BT Soares, MD
PRINCIPAL_INVESTIGATORWilson Salgado Jr, MD PhD
Hospital Estadual de Ribeirão Preto
Outcome results
None listed