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Идёт набор NCT04767490

Single Anastomosis Versus Standard Duodenal Switch

Без фазы С лечением Obesity Morbid Obesity

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: Standard Duodenal Switch, Single Anastomosis Duodenal Switch.
Кому может быть актуально
Состояния в реестре: Obesity, Morbid Obesity. Базовые параметры: 18 лет — 60 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Single Anastomosis Versus Standard Duodenal Switch - a Prospective Randomized Single-blinded Trial

Обзор

Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS. The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

Подробное описание

Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Our team, with more than 4000 BPD-DS performed since the early 1990's, is recognized internationally for its expertise with this specific procedure.

Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.

This new procedure, called Single Anastomosis Duodenal Switch has the potential benefit of decreasing the complexity of the standard BPD-DS by avoiding one of the two intestinal anastomoses usually needed. This could potentially decrease the rate of peri-operative complications and increase access to this type of surgery.

However, the length of the common channel (250cm) is more than doubled compared to standard BPD-DS, which could also change significantly the outcomes of the procedure itself. Indeed, the length of the common channel conditions the absorption of fat and fat-soluble vitamins.

Currently, the scientific literature regarding this procedure is scarce, with only one author who published his 2-years outcomes, in a cohort study of 100 patients. In addition, this report presents major limitations. In example, the length of the omega loop was increased from 200 to 250cm during the course of the study, in order to decrease the rate of protein deficiency and reoperation for malnutrition. This and other limitations make it hard to assess the actual results of the technique.

The overall objective of this study is to assess in a stronger study design (i.e. a prospective randomized single blinded trial), the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

Вмешательства

  • Процедура Standard Duodenal Switch
  • Процедура Single Anastomosis Duodenal Switch

Первичные конечные точки

  • Excess weight loss [Срок оценки: 2 years]
  • Rate of protein deficiency or insufficiency [Срок оценки: from baseline up to 60 months]
  • Mortality rate [Срок оценки: from baseline up to 60 months]
  • BMI [Срок оценки: 2 years]
Вторичные конечные точки (9)
  • Complication rate [Срок оценки: from baseline up to 60 months]
  • Cure rate of comorbidities [Срок оценки: from baseline up to 60 months]
  • Rate of minerals and vitamin deficiencies [Срок оценки: from baseline up to 60 months]
  • Body composition by bioimpedance measures [Срок оценки: from baseline up to 60 months]
  • Change in quality of life [Срок оценки: from baseline up to 60 months]
  • Change in quality of life [Срок оценки: from baseline up to 60 months]
  • Change in quality of life [Срок оценки: from baseline up to 60 months]
  • Change in quality of life [Срок оценки: from baseline up to 60 months]
  • Change in gatroesophageal reflux symptom [Срок оценки: from baseline to 60 months]

Критерии участия

Критерии включения

  • Age ≥18 years and ≤60 years
  • Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35
  • Give written informed consent

Критерии исключения

Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:

  • Presence of the following baseline comorbidities:
  • Inflammatory bowel disease (IBD),
  • Cirrhosis
  • History of gastric or duodenal ulcers
  • Preoperative hypoalbuminemia (<35 g/L)
  • History of severe renal, hepatic, cardiac or pulmonary disease
  • Past esophageal, gastric or bariatric surgery
  • Type 1 Diabetes
  • Pregnancy
  • Evidence of psychological problem that may affect the capacity to understand the project and to comply with the medical recommendations
  • History of drug use or alcohol abuse in the last 6 months
  • History of gastro-intestinal inflammatory diseases

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec

Идентификаторы

NCT: NCT04767490 · SADI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗