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临床试验/NCT00733434
NCT00733434Unknown4 期

Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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)

研究者

申办方类型
Other

研究点 (1)

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