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临床试验/NCT02325141
NCT02325141已完成不适用

Laparoscopic Sleeve Gasterectomy With or Without Pyloric Sphincter Botulinum Neurotoxin Injection: a Comparative Study

Mansoura University0 个研究点目标入组 130 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
主要终点
number pf patients developing postoperative gastric leakage

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index >40 or >35 with hypertension or DM

排除标准

  • Previous bariatric surgery

结局指标

主要结局

number pf patients developing postoperative gastric leakage

时间窗: 0ne year

次要结局

  • percent of patients with excess weight loss(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamer Youssef Mohamed

assistant professor of surgery

Mansoura University

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