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NCT04002713 Clinical Trial

Comparison of Choosing Free ALT or Free PMT for Reconstruction With Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Comparison of the Outcome of Choosing Free Anterolateral Thigh or Free Posterolateral Thigh Flap for Reconstruction in Patients With Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04002713
Other study ID # 201900308B0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2019
Est. completion date June 3, 2019

Study information
Verified date June 2019
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study was designed to compare the outcome of the anteromedial thigh (AMT) and anterolateral thigh (ALT) flaps in head and neck cancer reconstruction.

Description:

To compare the results of the AMT and ALT flaps, this study aimed to compare their outcomes in head and neck cancer reconstruction under the condition of attenuating baseline patient and operative characteristics with the selection of propensity score-matched patient cohorts.

Recruitment information / eligibility
Status Completed
Enrollment 1590
Est. completion date June 3, 2019
Est. primary completion date May 2, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility Inclusion Criteria:

- Patients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017.

Exclusion Criteria:

- Patients whose data were missing will be excluded.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ALT flap reconstruction
Patients who underwent ALT free flap reconstruction after head and neck cancer surgery.
• AMT flap reconstruction
Patients who underwent AMT free flap reconstruction after head and neck cancer surgery.

Locations
Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary survival or failure The primary free flap outcome was determined as its survival or failure. up to 6 months
Secondary Complications The second outcome was the associated complications (fistula, hematoma, partial necrosis, and wound infection). up to 6 months
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