National Registry of Obesity Treatment by Endosleeve

Обзор

Obesity and overweight have emerged as public health problems of a pandemic nature, significantly reducing the life expectancy of those affected. Obesity has a considerable medico-economic impact, linked to the treatments it requires and its comorbidities. Currently, the prevention of obesity in our Western societies is not effective enough, as the prevalence and incidence of obesity and overweight continue to rise worldwide. In France, the therapeutic management of this condition is governed by the HAS and is summarized as a surgical approach for type 2 obesity with comorbidity or type 3 obesity, with three authorized methods that have shown sufficient evidence: gastric banding, sleeve gastrectomy (or longitudinal sleeve gastrectomy), and Roux-en-Y gastric bypass. With the advent of organ-preserving interventional endoscopy, the systematic use of these surgical methods, although effective for total weight loss and excess weight loss, raises questions. Indeed, these new therapeutic endoscopic approaches, which are less invasive, less costly, and respectful of anatomy, currently show convincing cohort results in the short term (12 to 24 months) and require confirmation of their effectiveness and safety in the long term (5 years) so that they can become first-line therapeutic methods in the near future. At the request of the HAS in its self-referral of 2020 and then in 2022, this prospective registry aims to confirm the effectiveness and safety of the endosleeve (or endoscopic sleeve) in the long-term therapeutic management of obesity within the framework of everyday practice in national reference centers for obesity treatment.

Вмешательства

• Процедура Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)
  The patient will undergo therapeutic endoscopy under general anesthesia, either as outpatient or inpatient care, based on the recommendations of the investigating physician, taking into account anesthetic risks and comorbidities. Two CE-marked gastric suturing devices may be used at the discretion of the investigating center based on their practices OverStich™ allows for tissue fixation via a gastroscope, creating a durable suture through a transabdominal fixation technique. The procedure lasts

Первичные конечные точки

• Measurement of total weight loss (TWL) in % 5 years afther endosleeve [Срок оценки: 5 years]

Вторичные конечные точки (11)

• Measurement of total weight loss (TWL) in % [Срок оценки: 12 et 24 months]
• Measurement excess weight loss after the endosleeve intervention. [Срок оценки: 12, 24 months, and 5 years]
• Measurement of the percentage of postoperative complications according to the AGREE classification [Срок оценки: Day 1 and Day 30.]
• Measurement of remission (or regression) of pre-existing comorbidities [Срок оценки: 12 months, 24 months, and 5 years.]
• Occurrence of metabolic comorbidities [Срок оценки: 12 months, 24 months, and 5 years]
• Outpatient procedures [Срок оценки: 30 days]
• Bariatric procedures performed following the initial intervention [Срок оценки: Day 1 and Day 30.]
• Conversion rates in bariatric surgery and their feasibility [Срок оценки: 3 years and 5 years]
• Predictive factors for response, weight regain, and plateau at the EndoSleeve [Срок оценки: 3 months, 6 months and 1 year]
• Sequence of bariatric procedures that led to the best weight response [Срок оценки: 5 years]
• Measurement of the improvement in quality of life. [Срок оценки: 12 months , 24 months, and at 5 years of follow-up.]

Критерии участия

Критерии включения

• Age over 18 years;
• Patient with a body mass index (BMI) ≥ 30 kg/m²;
• Signed informed consent

Критерии исключения

• Contraindication to performing an upper endoscopy or using an endoscopic plication system according to the instructions for use (IFU);
• Presence of an ulcer in the gastric body or fundus;
• Achalasia, severe esophagitis (Los Angeles grade C or D);
• ENT or esophageal malformation;
• Gastrointestinal disease (including stenosis), history of previous gastric surgery (including bariatric surgery, previous endoscopic gastroplasty);
• Congestive gastropathy, gastric polyposis, gastric or esophageal varices, risk of gastric tumor disease due to personal or family history;
• Positive Helicobacter pylori status with failed eradication treatments;
• Uncontrolled or severe eating disorder or psychiatric illness;
• Substance abuse or chronic alcoholism;
• Severe renal insufficiency (stage 4 or 5), Cirrhosis Child B or C;
• Anticoagulant or antiplatelet treatment that cannot be stopped or replaced according to international recommendations (ESGE 2021);
• Coagulation or hemostasis disorders (PT < 60%, platelets < 60,000/mm³);
• Mental deficiency of the subject making participation in the trial impossible;
• Patient not affiliated with a social security scheme;
• Pregnant women, breastfeeding individuals;
• Inability to understand or sign the informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06657339 · SFED-153

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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