NCT04613635已完成不适用
Comparison of 2 Suture Materials for Closure of Ventral Defect At the Gastrojejunostomy in One-Anastomosis-Gastric Bypass / Mini-Gastric Bypass (OAGB / MGB): a Randomized Short Term Study with Monocrylic Spiral Knotless Tissue Control Device Vs. Traditional Polyglactin Multifilament Suture
St. Franziskus Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Closure of gastrojejunostomy
研究概览
简要总结
To compare shorttime (6 months) results of two competitive suture materials with regard to time demanded to perform the concerned surgical step and secondary to study anastomotic site safety and complications like leakage and hemorrhage as well as development of anastomotic strictures. Evaluation of cost-effectiveness.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients selected for primary Mini-Gastric bypass to treat obesity (BMI>30)
- •laparoscopic access feasable (intention to treat laparoscopically)
- •failed conservative treatment (accepted by health insurance companies)
- •relevant co-morbidities in cases with BMI <40
- •age 18 years or elder
排除标准
- •severe language problems
- •revisional or redo-procedures
- •operation intended as open procedure(extensive previous surgeries),
- •operation performed under corticoid-medication
- •operation performed under full-dose anticoagulants
- •operation performed by another surgeon than one of the 3 experienced MGB-surgeons of the Department
结局指标
主要结局
Closure of gastrojejunostomy
时间窗: The assessment of this surgical step will be completed during the operation.
time needed to perform this specific surgical step, i.e. the ventral defect closure of the (otherwise stapled) gastrojejunostomy
次要结局
- anastomotic site perioperative morbidity(6 months)
- other anastomosis- related morbidity(6 months)
- economical factors(6 months)
研究者
Andreas Plamper
Assistant Principal Investigator
St. Franziskus Hospital
研究点 (2)
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