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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00723-42 | Other Identifier | ANSM France |
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Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.
Effectiveness of sleeve gastrectomy is between gastric banding and gastric bypass. However, a proportion of patients that undergo surgery, report troublesome and persistent dysphagia, pain, new onset or worsening of gastro-esophageal reflux (GER) requiring treatment. Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome. Current investigations based on traditional intra-luminal imaging (endoscopy) and radiology (UGI series) may not provide adequate preoperative assessment of esophago-gastric dynamics. Current practice in the creation of a sleeve gastrectomy involves the use of a bougie or endoscope around which the sleeve is stapled. There is no consensus on the diameter of this bougie and this intraoperative calibration may alter the gastro-esophageal junction (GEJ) anatomy, does not provide real time physiology feedback, and allows only for a rough approximation of the size of the sleeve providing no information about the distensibility and pressure gradient of the newly created gastric tube as it is filled. A more distensible sleeve will have lower intra-gastric pressure, and thus will theoretically be expected to reduce the incidence of side effects. As laparoscopic sleeve gastrectomy is performed with increasing frequency, there is a need for development of tools to assist the surgeon in modeling properly and standardize the gastroplasty. This study will be based on a strict assessment of the anatomical and functional characteristics of the "ideal "gastric sleeve, using existing imaging modalities (endoscopy - CT scan- MRI - HRM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleeve gastrectomy | Other | All patients will undergo sleeve gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic sleeve gastrectomy | Procedure | Conventional laparoscopic sleeve gastrectomy using EndoFLIPĀ® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with postoperative GIQLI score greater than preoperative score | Patients with postoperative GIQLI (Gastro-Intestinal Quality of Life Index) score greater than preoperative score | 50% excess weight loss (about 6 months post surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (GIQLI) | Quality of life (Gastro-Intestinal Quality of Life Index) | 50% of excess weight loss (about 6 months post surgery) |
| GERD and dysphagia symptoms (GSAS questionnaire) | GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale |
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Inclusion Criteria:
Non-inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvana Perretta, Pr | Service de Chirurgie Digestive et Endocrinienne - Nouvel HƓpital Civil - Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Digestive et Endocrinienne - Nouvel HƓpital Civil | Strasbourg | 67000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32207049 | Derived | Quero G, Fiorillo C, Dallemagne B, Mascagni P, Curcic J, Fox M, Perretta S. The Causes of Gastroesophageal Reflux after Laparoscopic Sleeve Gastrectomy: Quantitative Assessment of the Structure and Function of the Esophagogastric Junction by Magnetic Resonance Imaging and High-Resolution Manometry. Obes Surg. 2020 Jun;30(6):2108-2117. doi: 10.1007/s11695-020-04438-y. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 50% of excess weight loss (about 6 months post surgery) |
| Functional examinations | Include:
| 50% of excess weight loss (about 6 months post surgery) |
| EndoFLIPĀ® measures | Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure | Intra-operatively |
| Surgical video analysis | Analysis of surgery videos to detect technical "errors" explaining clinical and/or functional outcome | within 6 months post surgery |
| Per and post-operative complications | Complications occuring during surgery and within 6 months of surgery (reach of 50% of excess weight loss) | within 6 months post surgery |
| Cost of exploratory exams | 50% excess weight loss (about 6 months post surgery) |
| Cost of exploratory exams | Within 2 months prior to surgery |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |