PGE1HNM: The Use of Prostaglandin E1 in Head and Neck Microsurgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days |
Drug: Prostaglandin E1
PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Other Names:
|
| Placebo Comparator: 2 Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days |
Other: Saline
500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Free flap re-exploration rate [7 days after microsurgery]
Secondary Outcome Measures
- Surgical complication rate [hospitalization period]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients requiring microvascular reconstruction after head and neck cancer resection
Exclusion Criteria:
- Patients with coagulation dysfunction
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Yueh-Bih Tang, MD, PhD, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 200707036R