Randomized Prospective Clinical Study Evaluating the Usefulness of Fibrin Glue (TISSEEL® KIT) to Prevent Gastric Fistula, Intra Abdominal Haemorrhage and Intra Abdominal Loco Regional Collections After Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 597
- 试验地点
- 2
- 主要终点
- presence of post-operative complications
研究概览
简要总结
Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice in the surgical management of patients with morbid obesity. However, this restrictive procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage (1%) and intra-abdominal loco regional collections (1%). At present, there is no sufficiently reliable technique to prevent these complications.
详细描述
The hypothesis is the following : the use of fibrin glue (Tissucol ®) during Laparoscopic Sleeve Gastrectomy would reduce the incidence of complications (gastric fistula, intra-abdominal hemorrhage and intra-abdominal locoregional collection).
The aim is to investigate whether the use of fibrin glue (Tissucol®) during Laparoscopic Sleeve Gastrectomy reduces the incidence of postoperative complications (gastric fistula, intra-abdominal hemorrhage and intra-abdominal locoregional collection)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity requiring bariatric surgery (Laparoscopic Sleeve Gastrectomy) according to the Haute Autorité de Santé
- •Patients younger than 60 years old
- •BMI ≤ 60 kg/m2
- •Surgery accepted by an Obesity-related specific committee
- •Patient with social protection
排除标准
- •Previous bariatric or gastric surgery
- •BMI > 60 kg/m2
- •Under 18 years old
- •Allergy to Tissucol®
- •peroperative fistula
- •Consent not signed
- •Incapable of giving his opinion
- •Pregnancy or breast-feeding
- •Contraindication to surgery
- •ASA classification IV
研究组 & 干预措施
tisseel
tisseel will be applied during the surgery
干预措施: tisseel (Drug)
no tisseel
no tisseel will be applied during the surgery
干预措施: no tisseel (Other)
结局指标
主要结局
presence of post-operative complications
时间窗: post operative day 30
The primary endpoint corresponds to the presence of complications after laparoscopic sleeve gastrectomy during the follow up period. A complication is considered as "present" if at least one of the following three items is present: * Gastric fistula * Postoperative hemorrhage * intra-abdominal locoregional collection
次要结局
- The gastric fistula's rate(post operative day 30)
- The postoperative hemorrhage's rate(post-operative day 30)
- the overall mortality at one month(post-operative day 30)
- the length of stay(post-operative day 30)
- The intra-abdominal locoregional collection's rate(post-operative day 30)
- the rate of readmission(post-operative day 30)
- the rate of reintervention(post-operative day 30)
- the specific mortality at one month(post-operative day 30)
- the rate of postoperative morbidity(postoperative day 30)