Clinical trial NCT00733434: The Use of Prostaglandin E1 in Head and Neck Microsurgery
Official title: Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Microsurgery
Head and Neck
Prostaglandin E1
Thrombosis
Complications
Keywords: Microsurgery
Head and neck
Prostaglandin E1
Thrombosis
Complication
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 242
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients requiring microvascular reconstruction after head and neck cancer resection

Exclusion Criteria:

* Patients with coagulation dysfunction

Primary outcomes:
measure: Free flap re-exploration rate
timeFrame: 7 days after microsurgery
Secondary outcomes:
measure: Surgical complication rate
timeFrame: hospitalization period
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yueh-Bih Tang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Disa JJ, Polvora VP, Pusic AL, Singh B, Cordeiro PG. Dextran-related complications in head and neck microsurgery: do the benefits outweigh the risks? A prospective randomized analysis. Plast Reconstr Surg. 2003 Nov;112(6):1534-9. doi: 10.1097/01.PRS.0000083378.58757.54.
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citation: Ashjian P, Chen CM, Pusic A, Disa JJ, Cordeiro PG, Mehrara BJ. The effect of postoperative anticoagulation on microvascular thrombosis. Ann Plast Surg. 2007 Jul;59(1):36-9; discussion 39-40. doi: 10.1097/01.sap.0000264837.15110.2f.
citation: Watanabe H, Anayama S, Horiuchi T, Sato E, Hamada Y, Ishihara H. Pleural effusion caused by prostaglandin E1 preparation. Chest. 2003 Mar;123(3):952-3. doi: 10.1378/chest.123.3.952.
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