National Registry of Obesity Treatment by Endosleeve
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 354
- 主要终点
- Measurement of total weight loss (TWL) in % 5 years afther endosleeve
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years;
- •Patient with a body mass index (BMI) ≥ 30 kg/m²;
- •Signed informed consent
排除标准
- •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.
结局指标
主要结局
Measurement of total weight loss (TWL) in % 5 years afther endosleeve
时间窗: 5 years
To determine the proportion of patients who met the PIVI criteria after endosleeve without additional techniques
次要结局
- Measurement of total weight loss (TWL) in %(12 et 24 months)
- Measurement excess weight loss after the endosleeve intervention.(12, 24 months, and 5 years)
- Measurement of the percentage of postoperative complications according to the AGREE classification(Day 1 and Day 30.)
- Measurement of remission (or regression) of pre-existing comorbidities(12 months, 24 months, and 5 years.)
- Occurrence of metabolic comorbidities(12 months, 24 months, and 5 years)
- Outpatient procedures(30 days)
- Bariatric procedures performed following the initial intervention(Day 1 and Day 30.)
- Conversion rates in bariatric surgery and their feasibility(3 years and 5 years)
- Predictive factors for response, weight regain, and plateau at the EndoSleeve(3 months, 6 months and 1 year)
- Sequence of bariatric procedures that led to the best weight response(5 years)
- Measurement of the improvement in quality of life.(12 months , 24 months, and at 5 years of follow-up.)
研究者
VANBIERVLIET
Director, Head of Endocopy, Principal Investigator, Medical doctor
Société Française d'Endoscopie Digestive