The Use of Prostaglandin E1 in Head and Neck Microsurgery

Phase 4

• Conditions: Microsurgery; Head and Neck; Prostaglandin E1; Thrombosis; Complications
• Interventions: Drug: Prostaglandin E1; Other: Saline

• Registration Number: NCT00733434
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-12
• Study First Posted: 2008-08-13
• Primary Completion: 2009-07
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-26
• Last Update Posted: 2009-10-27
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• Patients requiring microvascular reconstruction after head and neck cancer resection

Exclusion Criteria

• Patients with coagulation dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Prostaglandin E1	Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
2	Saline	Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days

Primary Outcome Measures

Name	Time	Method
Free flap re-exploration rate	7 days after microsurgery

Secondary Outcome Measures

Name	Time	Method
Surgical complication rate	hospitalization period

Trial Locations

Locations (1)

National taiwan University Hospital; 🇨🇳 Taipei, Taiwan