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Идёт набор NCT05242835

Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

Без фазы С лечением Obesity Obesity, Morbid

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, Obesity, Morbid. 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
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Обзор

Sleeve gastrectomy (SG) has become the most commonly performed weight loss surgery, accounting for 60% of all bariatric operations worldwide. While technically easier with less side-effects and nutritional risks than other operations, SG is also associated with a higher risk of failure (20 to 40%). In such case, the most effective option consists in adding an intestinal bypass called the Biliopancreatic Diversion with Duodenal Switch (BPD-DS). This surgery is, however, technically challenging and yields a significant risk of complications, nutritional deficiencies or gastro-intestinal side-effects. Recently, a simplified version of the Standard DS, called Single-Anastomosis Duodenoileal Switch (SADI-S) was endorsed by surgical societies as one of the approved bariatric procedures. There is currently no prospective or randomized data to support the effectiveness of this new procedure, especially as a revisional approach. The Overall Objective of this randomized controlled trial project is to establish the clinical benefits of the SADI-S as a revisional surgery after SG, while also considering critical issues related to sex and gender. The investigator Overall Hypothesis is that the SADI-S represents a relevant revisional option for weight loss and metabolic recovery in women and men suffering from severe obesity who had a previous SG. The investigator propose to address the following research question. Research Question: What are the clinical effects of SADI-S compared to standard DS when used as a revisional procedure after SG, in patients with obesity? Participants who need revisional surgery after SG will be enrolled in a prospective, randomized, double-blind (patient-evaluator), non-inferiority trial comparing SADI-S vs DS. The primary outcome will be 12-month excess weight loss. Secondary outcomes will be perioperative complications, risk of malnutrition, quality of life and gastrointestinal side effects. The investigator hypothesize that SADI-S offers similar weight loss compared to standard DS, but a lower risk of complications and nutritional deficiencies. With the increase in the number of bariatric operations performed worldwide and the recent endorsement of the SADI-S as a regular procedure, reliable clinical data are urgently needed. The present proposal will directly address this knowledge gap.

Вмешательства

  • Процедура Standard duodenal switch
    Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)
  • Процедура Single-anastomosis duodenal switch
    Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)

Первичные конечные точки

  • Excess weight loss [Срок оценки: 12 month]
Вторичные конечные точки (12)
  • Peroperative complications [Срок оценки: from baseline up to 60 months]
  • Risk of malnutrition [Срок оценки: from baseline to 60 months]
  • Change in quality of life (SF-36) [Срок оценки: from baseline to 60 months]
  • Change in quality of life (BAROS) [Срок оценки: from baseline to 60 months]
  • Change in quality of life (QLaval) [Срок оценки: from baseline to 60 months]
  • Gastro-intestinal side effects [Срок оценки: from baseline to 60 months]
  • Change in nutritional status (calcium) [Срок оценки: from baseline to 60 months]
  • Change in nutritional status (ferritin) [Срок оценки: from baseline to 60 months]
  • Change in nutritional status (TIBC) [Срок оценки: from baseline to 60 months]
  • Change in nutritional status (iron) [Срок оценки: from baseline to 60 months]
  • Change in nutritional status (prealbumin) [Срок оценки: from baseline to 60 months]
  • Change in nutritional status (transferrin) [Срок оценки: from baseline to 60 months]

Критерии участия

Критерии включения

  • had sleeve gastrectomy a minimum of 18 months before
  • still meet the NIH criteria for bariatric surgery (BMI≥35kg/m2 with major comorbidities or BMI≥40kg/m2) or patients with EWL<50% or significant weight regain (≥20%EWL)

Критерии исключения

  • general contra-indication for bariatric surgery
  • BMI<35kg/m2
  • pregnancy
  • cirrhosis
  • abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease

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
Четверное слепое
Основная цель
Лечение

Центры проведения

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

Идентификаторы

NCT: NCT05242835 · Second stage SADI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗