NCT06371365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

April 9, 2024

Last Update Submit

April 16, 2024

Conditions

Surgical FlapsFlap Failure Risk FactorsHematoma Risk FactorsThrombosis Risk Factors

Outcome Measures

Primary Outcomes (1)

  • Number of participants with flap failure

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

    30 days post-operation

Secondary Outcomes (2)

  • Number of participants with hematoma

    30 days post-operation

  • Number of participants with thrombosis

    30 days post-operation

Study Arms (1)

Patients underwent free flap surgery

Procedure: Free Flap surgery

Interventions

Free Flap surgeryPROCEDURE

No intervention, this is an observational study

Patients underwent free flap surgery

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (1)

  • Hsiung PH, Huang HY, Chen WY, Kuo YR, Lin YC. Cumulative risk factors for flap failure, thrombosis, and hematoma in free flap reconstruction for head and neck cancer: a retrospective nested case-control study. Int J Surg. 2024 Dec 1;110(12):7616-7623. doi: 10.1097/JS9.0000000000002069.

    PMID: 39236088DERIVED

Study Officials

  • Ying-Chi Lin, Ph.D.

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Master Degree Program in Toxicology

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 17, 2024

Study Start

October 19, 2022

Primary Completion

September 24, 2023

Study Completion

September 24, 2023

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)