The Use of Prostaglandin E1 in Head and Neck Microsurgery (PGE1HNM)
Primary Purpose
Microsurgery, Head and Neck, Prostaglandin E1
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Prostaglandin E1
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Microsurgery focused on measuring Microsurgery, Head and neck, Prostaglandin E1, Thrombosis, Complication
Eligibility Criteria
Inclusion Criteria:
- Patients requiring microvascular reconstruction after head and neck cancer resection
Exclusion Criteria:
- Patients with coagulation dysfunction
Sites / Locations
- National taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Outcomes
Primary Outcome Measures
Free flap re-exploration rate
Secondary Outcome Measures
Surgical complication rate
Full Information
NCT ID
NCT00733434
First Posted
August 12, 2008
Last Updated
October 26, 2009
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00733434
Brief Title
The Use of Prostaglandin E1 in Head and Neck Microsurgery
Acronym
PGE1HNM
Official Title
Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microsurgery, Head and Neck, Prostaglandin E1, Thrombosis, Complications
Keywords
Microsurgery, Head and neck, Prostaglandin E1, Thrombosis, Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Intervention Type
Drug
Intervention Name(s)
Prostaglandin E1
Other Intervention Name(s)
Alprostadil, Promostan
Intervention Description
PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Intervention Type
Other
Intervention Name(s)
Saline
Other Intervention Name(s)
Normal saline
Intervention Description
500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Primary Outcome Measure Information:
Title
Free flap re-exploration rate
Time Frame
7 days after microsurgery
Secondary Outcome Measure Information:
Title
Surgical complication rate
Time Frame
hospitalization period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients requiring microvascular reconstruction after head and neck cancer resection
Exclusion Criteria:
Patients with coagulation dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yueh-Bih Tang, MD, PhD
Phone
886-2-23123456
Ext
5107
Email
phoebetang@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yueh-Bih Tang, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yueh-Bih Tang, MD, PhD
Phone
886-2-23123456
Ext
5107
Email
phoebetang@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Yueh-Bih Tang, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
14578781
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.
Results Reference
background
PubMed Identifier
17596843
Citation
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.
Results Reference
background
PubMed Identifier
17589257
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.
Results Reference
background
PubMed Identifier
12628901
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.
Results Reference
background
PubMed Identifier
12058249
Citation
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.
Results Reference
background
PubMed Identifier
11901464
Citation
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.
Results Reference
background
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The Use of Prostaglandin E1 in Head and Neck Microsurgery
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