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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic sleeve gastroplasty | Therapeutic endoscopy using a gastric suturing device (OverStitch™/Endomina™) according to the practices of the investigating center |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of total weight loss (TWL) in % | Determine total weight loss (TWL) afther endosleeve at 12, 24 months, | 12 et 24 months |
| Measurement excess weight loss after the endosleeve intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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Any referred patient with obesity and a BMI > 30 kg/m² who meets the inclusion criteria and is considered suitable for therapeutic management of obesity will be invited to participate in the study at the investigating centers
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
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
| 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%). | Day 1 and Day 30. |
| Measurement of remission (or regression) of pre-existing comorbidities | Determine the impact on pre-existing metabolic comorbidities :
| 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 | 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 | 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) | 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) | 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) | 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 | 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. | 12 months , 24 months, and at 5 years of follow-up. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |