The Impact of Early Versus Late Drain Removal on Postoperative Morbidity After Pancreatectomy: A Randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Intra-abdominal infection
研究概览
简要总结
The aim of this study is to demonstrate the hypothesis that early removal of drain can reduce the incidence of intra-abdominal infection and pancreatic fistula after pancreatectomy compared with later removal of drain.
详细描述
This study is to analyze the association between the time of removal of drain after pancreatic resection and incidence of intra-abdominal complications, such as intra-abdominal infection and pancreatic leakage. We design a prospective randomized study. Patients with pancreatic and periampullar tumors who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) are recruited to the study if amylase value in drain(s) is less than 5000 U/L on postoperative day (POD) 1. After obtaining informed consent, eligible patients are randomly allocated to early or late drain removal group on POD 3. In the group A, drain(s) are removed on POD 3, whereas in group B drain is removed on POD 4 or beyond. The primary outcomes are the incidence of intra-abdominal infection and pancreatic fistula; the secondary outcomes include intra-abdominal bleeding, delayed gastric emptying, pulmonary complications, and length of hospital stay.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: >18yr, <75yr
- •Patients with pancreatic diseases (including tumor and inflammatory disease) or non-pancreatic tumors (biliary duct cancer or ampullary tumor) who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP)
- •The amylase value in drain(s) is less than 5000 U/L on postoperative day 1 and 3.
排除标准
- •Reconstruction of the pancreatic remnant by pancreaticogastrostomy
- •Intra-abdominal hemorrhage within 72 hours after operation
- •Biliary fistula (output of biliary fluid from at least 1 abdominal drain) within 72 hours after operation
- •Chylous leakage (milky water) within 72 hours after operation
- •The volume of drain effluent (ascites) is greater than 300 ml within 72 hours after operation.
结局指标
主要结局
Intra-abdominal infection
时间窗: Up to postoperative 30 days
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
Pancreatic fistula
时间窗: Up to postoperative 30 days
The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
次要结局
- Intra-abdominal bleeding(Up to postoperative 30 days)
- Delayed gastric emptying(Up to postoperative 30 days)
- Pulmonary complications(Up to postoperative 30 days)
- Length of hospital stay (day)(Up to postoperative 2 weeks)