The Use of Prostaglandin E1 in Head and Neck Microsurgery

NCT ID: NCT00733434

Last Updated: 2009-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

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.

Conditions

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Microsurgery Head and Neck Prostaglandin E1 Thrombosis Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Prostaglandin E1

Intervention Type DRUG

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

2

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

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

Interventions

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Prostaglandin E1

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

Intervention Type DRUG

Saline

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

Intervention Type OTHER

Other Intervention Names

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Alprostadil, Promostan Normal saline

Eligibility Criteria

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Inclusion Criteria

* Patients requiring microvascular reconstruction after head and neck cancer resection

Exclusion Criteria

* Patients with coagulation dysfunction
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Principal Investigators

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Yueh-Bih Tang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yueh-Bih Tang, MD, PhD

Role: CONTACT

886-2-23123456 ext. 5107

Facility Contacts

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Yueh-Bih Tang, MD, PhD

Role: primary

886-2-23123456 ext. 5107

References

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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.

Reference Type BACKGROUND
PMID: 14578781 (View on PubMed)

Rodriguez Vegas JM, Ruiz Alonso ME, Teran Saavedra PP. PGE-1 in replantation and free tissue transfer: early preliminary experience. Microsurgery. 2007;27(5):395-7. doi: 10.1002/micr.20377.

Reference Type BACKGROUND
PMID: 17596843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17589257 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12628901 (View on PubMed)

Barthelmes L, Chezhian C, Aihaku EK. Deep venous thrombosis and venous thrombophlebitis associated with alprostadil treatment for erectile dysfunction. Int J Impot Res. 2002 Jun;14(3):199-200. doi: 10.1038/sj.ijir.3900853.

Reference Type BACKGROUND
PMID: 12058249 (View on PubMed)

Lee KS, Suh JD, Han SB, Yoo JC, Lee SJ, Cho SJ. The effect of aspirin and prostaglandin E(1) on the patency of microvascular anastomosis in the rats. Hand Surg. 2001 Dec;6(2):177-85. doi: 10.1142/s0218810401000643.

Reference Type BACKGROUND
PMID: 11901464 (View on PubMed)

Other Identifiers

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200707036R

Identifier Type: -

Identifier Source: org_study_id

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