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

June 27, 2019 updated by: Chang Gung Memorial Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1590

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, 83301
        • Kaohsiung Chang Gung 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

16 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A retrospective study was performed on adult trauma patients from the registered free flap database and electric medical records of Kaohsiung Chang Gung Memorial Hospital, a 2,686-bed medical center in Southern Taiwan.

Description

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 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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ALT&AMT free flap reconstruction
Patients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017
Other: ALT flap reconstruction
Patients who underwent ALT free flap reconstruction after head and neck cancer surgery.
Other: AMT flap reconstruction
Patients who underwent AMT free flap reconstruction after head and neck cancer surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival or failure
Time Frame: up to 6 months
The primary free flap outcome was determined as its survival or failure.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: up to 6 months
The second outcome was the associated complications (fistula, hematoma, partial necrosis, and wound infection).
up to 6 months

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

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)

March 20, 2019

Primary Completion (Actual)

May 2, 2019

Study Completion (Actual)

June 3, 2019

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Actual)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201900308B0

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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