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The Use of Prostaglandin E1 in Head and Neck Microsurgery

Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Microsurgery; Head and Neck; Prostaglandin E1; Thrombosis; Complications

Intervention: Prostaglandin E1 (Drug); Saline (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Taiwan University Hospital

Official(s) and/or principal investigator(s):
Yueh-Bih Tang, MD, PhD, Principal Investigator, Affiliation: National Taiwan University Hospital

Overall contact:
Yueh-Bih Tang, MD, PhD, Phone: 886-2-23123456, Ext: 5107, Email: phoebetang@ntu.edu.tw

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Free flap re-exploration rate

Secondary outcome: Surgical complication rate

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

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients requiring microvascular reconstruction after head and neck cancer resection

Exclusion Criteria:

- Patients with coagulation dysfunction

Locations and Contacts

Yueh-Bih Tang, MD, PhD, Phone: 886-2-23123456, Ext: 5107, Email: phoebetang@ntu.edu.tw

National taiwan University Hospital, Taipei 100, Taiwan; Recruiting
Yueh-Bih Tang, MD, PhD, Phone: 886-2-23123456, Ext: 5107, Email: phoebetang@ntu.edu.tw
Yueh-Bih Tang, MD, PhD, Principal Investigator
Additional Information

Related publications:

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.

Rodríguez Vegas JM, Ruiz Alonso ME, Terán Saavedra PP. PGE-1 in replantation and free tissue transfer: early preliminary experience. Microsurgery. 2007;27(5):395-7.

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.

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.

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. Review.

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.

Starting date: July 2008
Last updated: October 26, 2009

Page last updated: August 23, 2015

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