Clinical, Metabolic, and Physiological Evaluation of Conversion From Sleeve Gastrectomy to Intestinal Transit Bipartition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Solid-Meal Gastric Emptying Half-Time (T½)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Liver cirrhosis;
- •Absence of willingness to undergo a new surgical procedure.
研究组 & 干预措施
Transit Bipartition After Sleeve Gastrectomy
Participants with previous sleeve gastrectomy undergo revisional conversion to intestinal transit bipartition and are followed for 12 months.
干预措施: Conversion to Intestinal Transit Bipartition (Procedure)
结局指标
主要结局
Change in Solid-Meal Gastric Emptying Half-Time (T½)
时间窗: 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.
次要结局
- Change in Esophageal Acid Exposure(Baseline to 6 months)
- Route-Specific Gastric Transit(6 months)
- Change in GLP-1 AUC(Baseline to 6 months)
- Change in Glycemic Measures(Baseline to 6 months)
- Change in Fecal Elastase(Baseline to 6 months)
- Change in Body Weight(Baseline; 3, 6, 9, and 12 months)
- Change in GERD-HRQL Score(Baseline to 6 months)
- Change in DeMeester Score(Baseline to 6 months)