The Use of Prostaglandin E1 in Head and Neck Microsurgery (PGE1HNM)

National Taiwan University

Status and phase: Unknown; Phase 4

Conditions: Microsurgery; Head and Neck; Thrombosis; Prostaglandin E1; Complications

Treatments: Other: Saline; Drug: Prostaglandin E1

Study type: Interventional

Funder types: Other

Identifiers

NCT00733434

200707036R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients requiring microvascular reconstruction after head and neck cancer resection

Exclusion criteria

• Patients with coagulation dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days

Treatment:

Drug: Prostaglandin E1

2

Placebo Comparator group

Description:

Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days

Treatment:

Other: Saline