The Use of Prostaglandin E1 in Head and Neck Microsurgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Microsurgery, Head and Neck, Prostaglandin E1, Thrombosis, Complications

Intervention / Treatment
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* Drug: Prostaglandin E1
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring microvascular reconstruction after head and neck cancer resection Exclusion Criteria: Patients with coagulation dysfunction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days | Drug: Prostaglandin E1<br>* PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days<br>* Other names: Alprostadil, Promostan;|
| Placebo Comparator: 2<br>Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days | Other: Saline<br>* 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free flap re-exploration rate |  | 7 days after microsurgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complication rate |  | hospitalization period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microsurgery, Head and neck, Prostaglandin E1, Thrombosis, Complication