Adverse Events for Free Flap Surgery in Head and Neck Cancer

Completed

• Conditions: Surgical Flaps; Flap Failure Risk Factors; Thrombosis Risk Factors; Hematoma Risk Factors
• Interventions: Procedure: Free Flap surgery

• Registration Number: NCT06371365
• Lead Sponsor: Kaohsiung Medical University

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.

Study Timeline

• Study Start: 2022-10-19
• Primary Completion: 2023-09-24
• Study Completion: 2023-09-24
• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-12
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients underwent free flap surgery	Free Flap surgery	-

Primary Outcome Measures

Name	Time	Method
Number of participants with flap failure	30 days post-operation	Flap necrosis with a need for a new flap or other surgical procedures.

Secondary Outcome Measures

Name	Time	Method
Number of participants with thrombosis	30 days post-operation	Surgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.
Number of participants with hematoma	30 days post-operation	Surgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan