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The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal suture approach without any incision. It could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.
The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity.
Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.
The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity according to the technique described in the literature: reduction of the gastric pouch into a sleeve structure by modification of the stomach greater curvature thanks to a plication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic sleeve gastroplasty | Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic sleeve gastroplasty | Procedure | Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure | |
| Excess weight loss | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure | |
| Body mass index variation | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure reproducibility | Absence of adverse event within 12 months after procedure. | 7 days, 1 - 3 - 6 - 9 and 12 months after procedure |
| Comorbidities improvement | Improvement of hyperlipidemia, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients over 18 years old requiring a treatment for morbid obesity.
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| Name | Affiliation | Role |
|---|---|---|
| Silvana Perretta, MD, PhD | Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg | Principal Investigator |
| Michel Vix, MD | Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg | Strasbourg | 67000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25380508 | Background | Lopez-Nava G, Galvao MP, da Bautista-Castano I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7. | |
| 26003549 | Background | Lopez-Nava G, Galvao MP, Bautista-Castano I, Jimenez-Banos A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure |
| Quality of life improvement | Improvement of quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire and Gastro-intestinal Quality of Life Index questionnaire. | 3 - 12 - 18 and 24 months after procedure |
| Modification in the feeling of satiety | Satiety assessed by Three Factors Eating Questionnaire - R18. | 1 - 3 - 6 - 12 - 18 and 24 months after procedure |
| 26878054 | Background | Lopez-Nava G, Galvao M, Bautista-Castano I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15. |
| 25380510 | Background | Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7. |
| 23711556 | Background | Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |