Adverse Events for Free Flap Surgery in Head and Neck Cancer

April 16, 2024 updated by: Ying-Chi Lin, Kaohsiung Medical University

Prescription Pattern and Adverse Events of Postoperative Antithrombotic Regimes 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient greater than or equal to 20 years old who had free flap surgery following cancer ablation for head and neck cancer.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients underwent free flap surgery
Procedure: Free Flap surgery
No intervention, this is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days post-operation
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.
30 days post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University

Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Ying-Chi Lin, Ph.D., Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2022

Primary Completion (Actual)

September 24, 2023

Study Completion (Actual)

September 24, 2023

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-E(II)-20220204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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