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Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.
Laparoscopic sleeve gastrectomy (LSG) provides similar weight loss and resolution of obesity comorbidities to that of duodenal switch and Roux-en-Y gastric bypass. Inspite of its encouraging results, the pretended feasibility of the operative procedure can be associated with a remarkable operative morbidity. The main reason is gastric leakage from stable line which occurs in about 0-20% of the cases. The main accepted cause of leakage is formation of a high gastric tube pressure. Injection of BTX-A into the pyloric sphincter intraoperative will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure inside the gastric pouch will be decreased abolishing the formation of high pressure tube with subsequent leakage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSG | Active Comparator | patients undergoing laparoscopic sleeve gastrectomy without BTX-A injection into the pyloric sphincter |
|
| BTX-LSG | Active Comparator | patients undergoing laparoscopic sleeve gastrectomy with BTX-A injection into the pyloric sphincter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic sleeve gastrectomy | Procedure | creation of a gastric tube of 100cc using a stapler. |
|
| Measure | Description | Time Frame |
|---|---|---|
| number pf patients developing postoperative gastric leakage | 0ne year |
| Measure | Description | Time Frame |
|---|---|---|
| percent of patients with excess weight loss | one year |
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Inclusion Criteria:
Body mass index >40 or >35 with hypertension or DM
Exclusion Criteria:
Previous bariatric surgery
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |