The Use of Prostaglandin E1 in Head and Neck Microsurgery (PGE1HNM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00733434
First received: August 12, 2008
Last updated: October 26, 2009
Last verified: October 2009

August 12, 2008
October 26, 2009
July 2008
July 2009   (final data collection date for primary outcome measure)
Free flap re-exploration rate [ Time Frame: 7 days after microsurgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00733434 on ClinicalTrials.gov Archive Site
Surgical complication rate [ Time Frame: hospitalization period ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Use of Prostaglandin E1 in Head and Neck Microsurgery
Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Microsurgery
  • Head and Neck
  • Prostaglandin E1
  • Thrombosis
  • Complications
  • Drug: Prostaglandin E1
    PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
    Other Name: Alprostadil, Promostan
  • Other: Saline
    500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
    Other Name: Normal saline
  • Experimental: 1
    Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
    Intervention: Drug: Prostaglandin E1
  • Placebo Comparator: 2
    Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
    Intervention: Other: Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
242
July 2010
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients requiring microvascular reconstruction after head and neck cancer resection

Exclusion Criteria:

  • Patients with coagulation dysfunction
Both
20 Years to 80 Years
No
Contact: Yueh-Bih Tang, MD, PhD 886-2-23123456 ext 5107 phoebetang@ntu.edu.tw
Taiwan
 
NCT00733434
200707036R
Yes
Yueh-Bih Tang, Professor of Surgery, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Yueh-Bih Tang, MD, PhD National Taiwan University Hospital
National Taiwan University Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP