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.
Study Type
OBSERVATIONAL
Enrollment
354
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 about 45 minutes and includes measures to prevent vomiting. Endomina™ is a single-use device that captures the gastric mucosa to create successive plications, allowing for effective suturing along the greater curvature of the stomach.
Measurement of total weight loss (TWL) in % 5 years afther endosleeve
To determine the proportion of patients who met the PIVI criteria after endosleeve without additional techniques
Time frame: 5 years
Measurement of total weight loss (TWL) in %
Determine total weight loss (TWL) afther endosleeve at 12, 24 months,
Time frame: 12 et 24 months
Measurement excess weight loss after the endosleeve intervention.
Determine excess weight loss (EWL) after the endosleeve intervention, with positivity established by the PIVI criteria (EWL \> 25% at 12 months), and evaluate the long-term evolution of this EWL
Time frame: 12, 24 months, and 5 years
Measurement of the percentage of postoperative complications according to the AGREE classification
The safety of this procedure will be evaluated by recording complications perioperatively (Day 1) and post-procedure (Day 30) according to the AGREE criteria and using the PIVI criteria (positive if the complication rate is \< 5%).
Time frame: Day 1 and Day 30.
Measurement of remission (or regression) of pre-existing comorbidities
Determine the impact on pre-existing metabolic comorbidities : 1. Diabetes remission = HbA1C \< 6.5%, 3 months after discontinuation of all treatment / Regression or improvement of diabetes involving a decrease of more than 0.5% in HbA1C according to recognized criteria 2. Hypertension = Systolic blood pressure (SBP) \< 140 mmHg and/or Diastolic blood pressure (DBP) \< 90 mmHg without any treatment / Decrease in the number of therapeutic classes; 3. Obstructive Sleep Apnea Syndrome (OSAS) = Number of apneas less than 5 without equipment / Decrease in OSAS stage = mild (5 to 15 per hour), moderate (15 to 30), or severe (more than 30) with or without equipment; 4. Steatohepatitis = quantification by MRI of the % of fat in the liver with a decrease of more than 30%; 5. Dyslipidemia = normalization or improvement of LDL cholesterol and triglyceride levels without the addition of new drug therapies.
Time frame: 12 months, 24 months, and 5 years.
Occurrence of metabolic comorbidities
The occurrence of metabolic comorbidities such as diabetes, hypertension (HTN), obstructive sleep apnea syndrome (OSAS), steatohepatitis, and dyslipidemia will be assessed at 12, 24 months, and at the end of the follow-up period. Each comorbidity will be evaluated according to its specific definitional criteria
Time frame: 12 months, 24 months, and 5 years
Outpatient procedures
Number of outpatient procedures performed without the need for readmission within 30 days of follow-up
Time frame: 30 days
Bariatric procedures performed following the initial intervention
Number and type of bariatric procedures performed following the initial intervention (Redo EndoSleeve, medication treatment such as GLP-1 agonists or equivalent, instrumental treatment with a balloon or other methods)
Time frame: Day 1 and Day 30.
Conversion rates in bariatric surgery and their feasibility
Number of conversions to bariatric surgery (Sleeve and bypass) and their feasibility (whether the procedure was possible)
Time frame: 3 years and 5 years
Predictive factors for response, weight regain, and plateau at the EndoSleeve
Determination of predictive factors for response, failure (\<5% total weight loss at 6 months), weight regain (50% of the lost weight regained at or after one year), and plateau with EndoSleeve (≥10% weight loss but no further loss for more than 3 months)
Time frame: 3 months, 6 months and 1 year
Sequence of bariatric procedures that led to the best weight response
Description of the sequence of bariatric procedures leading to the best weight loss outcome after 5 years of follow-up
Time frame: 5 years
Measurement of the improvement in quality of life.
Impact on quality of life will be measured through quality of life questionnaires (BAROS questionnaire) before the intervention and during each medical visit, to assess psychological health before and after the intervention.
Time frame: 12 months , 24 months, and at 5 years of follow-up.
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