Complications, Head and Neck, Microsurgery, Prostaglandin E1, Thrombosis
Conditions
Keywords
Microsurgery, Head and neck, Prostaglandin E1, Thrombosis, Complication
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.
Interventions
DRUGProstaglandin E1
PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
OTHERSaline
500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients requiring microvascular reconstruction after head and neck cancer resection
Exclusion criteria
* Patients with coagulation dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Free flap re-exploration rate | 7 days after microsurgery |
Secondary
| Measure | Time frame |
|---|---|
| Surgical complication rate | hospitalization period |
Countries
Taiwan
Contacts
Primary ContactYueh-Bih Tang, MD, PhD
Outcome results
None listed