NCT05270564招募中不适用
Post-operative Drainage After Pancreaticoduodenectomy: A Randomized Controlled Trial of Patients With Intermediate and Low Risk for Pancreatic Fistula
Linkoeping University3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Overall morbidity rate
研究概览
简要总结
The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.
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
- •Patients undergoing pancreaticoduodenectomy of both sexes
- •Patients with predicted risk score of 10 or less of pancreatic fistula
- •Written informed consent
- •Expected survival time > 6 months
排除标准
- •Patients with predicted high risk of fistula with a risk score above 10
- •Patients with intraabdominal abscess or infection
- •ASA score > 3
- •Pregnancy
- •Expected lack of compliance
结局指标
主要结局
Overall morbidity rate
时间窗: 90 days post operatively
Post operative morbidity
次要结局
- Need of interventional radiology(90 days post operatively)
- Mortality rate (in-hospital, 30 and 90 days)(90 days post operatively)
- Severe morbidity rate as classified by Clavien-Dindo >3(90 days post operatively)
- Fistula rate according to ISGPF(90 days post operatively)
- Intraabdominal abscess rate(90 days post operatively)
- Need for reoperation(90 days post operatively)
- Hospital stay(90 days post operatively)
- Readmission rate(90 days post operatively)
- Wound infection rate(90 days post operatively)
- Delayed gastric emptying according to ISGPF(90 days post operatively)
- Postpancreatectomy bleeding according to ISGPF(90 days post operatively)
研究者
Bergthor Björnsson
Associate Professor
Linkoeping University
研究点 (3)
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