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Completed

NCT Number: NCT06371365

Adverse Events for Free Flap Surgery in Head and Neck Cancer

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free Flap surgery

Procedure

No intervention, this is an observational study

Primary outcomes

  1. Number of participants with flap failure

    Time frame: 30 days post-operation

    Flap necrosis with a need for a new flap or other surgical procedures.

Secondary outcomes

  1. Number of participants with hematoma

    Time frame: 30 days post-operation

    Surgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.

  2. Number of participants with thrombosis

    Time frame: 30 days post-operation

    Surgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University

Other

Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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