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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03599-44 | Other Identifier | ANSM France |
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Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.
The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.
Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Despite its advantages (long term weight loss, comorbidities related to obesity improvement…), bariatric surgery is risky. In fact, complications putting the patient into a life-threatening condition can occur. Endoscopic approaches are similar to current surgical methods but less invasive, safer and allow ambulatory care.
Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This leads to similar results (gastric restriction, weight loss, quality of life and comorbidities improvement) compared with standard surgical procedure while reducing the risk of complications.
One of the major benefit of this technique is its reversibility. A new surgical or endoscopic procedure is possible at a later stage.
Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.
The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic gastric tubulization | Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic gastric tubulization | Procedure | Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight loss | Change in weight loss measured in kilograms. | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure |
| Change in excess weight loss | Change in excess weight loss measured in percentage. Excess weight loss = (weight loss at time point / weight loss goal to reach a body mass index of 25 kg/m²) x 100 | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure |
| Change in body mass index variation | Change in body mass index variation measured in kg/m². | 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with procedure-related adverse event | Number of patients with procedure-related adverse event within 12 months after procedure. | 7 days, 1 - 3 - 6 - 9 and 12 months after procedure |
| Comorbidities improvement |
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Inclusion Criteria:
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Patients over 18 years old requiring a treatment for morbid obesity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvana Perretta, MD, PhD | Contact | + 33 3 69 55 05 31 | silvana.perretta@ircad.fr | |
| Michel Vix, MD | Contact | + 33 3 69 55 13 03 | michel.vix@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Silvana Perretta, MD, PhD | Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg | Principal Investigator |
| Michel Vix, MD | Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil | Recruiting | Strasbourg | 67091 | 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 |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Improvement of sleep apnea, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data.
| 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 questionnaire II. Score range from -3.0 to 3.0.
| 3 - 12 - 18 and 24 months after procedure |
| Gastro-intestinal quality of life improvement | Improvement of quality of life assessed by the Gastro-Intestinal Quality of Life Index questionnaire. A global score > 125 is considered as normal. | 3 - 12 - 18 and 24 months after procedure |
| Modification in the feeling of satiety | Satiety assessed by Three Factors Eating Questionnaire - R18. Three dimensions are assessed. The higher the score is, the more important the dimension is.
| 1 - 3 - 6 - 12 - 18 and 24 months after procedure |
| Upper GI tract radiologic evaluation | Upper GI control series. | 1 day, 6 - 12 and 24 months after procedure |
| Upper GI tract endoscopic evaluation | Upper GI control gastroscopy. | 6 - 12 and 24 months after procedure |
| Procedure duration | Time required to perform the endoscopic gastric tubulization. | At time of procedure |
| Number of stitches in place | Number of stitches put in place during the endoscopic gastric tubulization. | At time of 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 |
| D001836 | Body Weight Changes |