Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery
试验速览
- 阶段
- 4 期
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Free flap re-exploration rate
研究概览
简要总结
Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, with a comparable complication rate as the control group.
详细描述
Despite meticulous microsurgical techniques, free flap failure due to postoperative vessel thrombosis cannot be completely eliminated. Postoperative pharmacological augmentation of the established blood flow is considered as a feasible solution to this problem. Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 in every patient after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, and yielded a comparable complication rate as the control group.
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
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring microvascular reconstruction after head and neck cancer resection
排除标准
- •Patients with coagulation dysfunction
研究组 & 干预措施
1
Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
干预措施: Prostaglandin E1 (Drug)
2
Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
干预措施: Saline (Other)
结局指标
主要结局
Free flap re-exploration rate
时间窗: 7 days after microsurgery
次要结局
- Surgical complication rate(hospitalization period)
