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Adverse Events for Free Flap Surgery in Head and Neck Cancer

Prescription Pattern and Adverse Events of Postoperative Antithrombotic Regimes for Free Flap Surgery in Head and Neck Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06371365
Enrollment
540
Registered
2024-04-17
Start date
2022-10-19
Completion date
2023-09-24
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flap Failure Risk Factors, Hematoma Risk Factors, Surgical Flaps, Thrombosis Risk Factors

Brief summary

This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022.

Detailed description

Patient information are collected from the electronic medical records retrospectively: Head and Neck cancer diagnosis: The International Classification of Diseases, Tenth Revision (ICD-10), which included C00-C14, C31, C32, C73, C75.0, C75.4 and C41.1. The cancer stage, alcohol use, betel nut, and smoking, and baseline comorbidities. Surgical characteristics including flap history, ablation time, reconstruction time, donor sites, recipient sites, neck dissection, flap size, anastomosis, artery types, vein types, intraoperative sealants used, and intravenous calcium channel blocker nicardipine to control hypertension after surgery.

Interventions

No intervention, this is an observational study

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
CollaboratorOTHER
Kaohsiung Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age greater and equal to 20 years old * Underwent free flap surgery * Had head and neck cancer

Exclusion criteria

* HIV positive * Pregnant, breast feeing women * Missing surgical charts

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with flap failure30 days post-operationFlap necrosis with a need for a new flap or other surgical procedures.

Secondary

MeasureTime frameDescription
Number of participants with hematoma30 days post-operationSurgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.
Number of participants with thrombosis30 days post-operationSurgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026