Adverse Events for Free Flap Surgery in Head and Neck Cancer

Surgical Flaps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06371365
• Other study ID #: KMUHIRB-E(II)-20220204
• Status: Completed
• Start date: October 19, 2022
• Est. completion date: September 24, 2023

Study information

• Verified date: April 2024
• Source: Kaohsiung Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: September 24, 2023
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Hematoma
• Surgical Flaps
• Thrombosis

Intervention

Procedure:
• Free Flap surgery
No intervention, this is an observational study

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University	Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with flap failure	Flap necrosis with a need for a new flap or other surgical procedures.	30 days post-operation
Secondary	Number of participants with hematoma	Surgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.	30 days post-operation
Secondary	Number of participants with thrombosis	Surgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.	30 days post-operation