Набор скоро начнётся NCT07728682

Transit Bipartition After Sleeve Gastrectomy

Без фазы С лечением Obesity & Overweight Gastroesophageal Reflux (GERD) Weight Recurrence Bariatric Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Conversion to Intestinal Transit Bipartition.
Кому может быть актуально: Состояния в реестре: Obesity & Overweight, Gastroesophageal Reflux (GERD), Weight Recurrence, Bariatric Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical, Metabolic, and Physiological Evaluation of Conversion From Sleeve Gastrectomy to Intestinal Transit Bipartition

Обзор

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.

Подробное описание

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.

Вмешательства

Процедура Conversion 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.

Первичные конечные точки

Change in Solid-Meal Gastric Emptying Half-Time (T½) [Срок оценки: Baseline to 6 months after transit bipartition]

Вторичные конечные точки (8)

Change in GERD-HRQL Score [Срок оценки: Baseline to 6 months]
Change in DeMeester Score [Срок оценки: Baseline to 6 months]
Change in Esophageal Acid Exposure [Срок оценки: Baseline to 6 months]
Route-Specific Gastric Transit [Срок оценки: 6 months]
Change in GLP-1 AUC [Срок оценки: Baseline to 6 months]
Change in Glycemic Measures [Срок оценки: Baseline to 6 months]
Change in Fecal Elastase [Срок оценки: Baseline to 6 months]
Change in Body Weight [Срок оценки: Baseline; 3, 6, 9, and 12 months]

Критерии участия

Критерии включения

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.