- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04002713
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
-
-
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Kaohsiung, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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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
18 years to 98 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
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Patients who underwent ALT free flap reconstruction after head and neck cancer surgery.
Patients who underwent AMT free flap reconstruction after head and neck cancer surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
survival or failure
Time Frame: up to 6 months
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The primary free flap outcome was determined as its survival or failure.
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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
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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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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University of California, San FranciscoCompleted
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Radboud University Medical CenterUnknown
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Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
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University Hospital Southampton NHS Foundation...The Leeds Teaching Hospitals NHS Trust; University of Southampton; Newcastle-upon-Tyne... and other collaboratorsRecruitingQuality of Life | Surgery--Complications | Abdominal Cancer | Pelvic CancerUnited Kingdom
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Mansoura UniversityUnknown
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Mohamed Tahar Maamouri University HospitalCompletedMaxillofacial Injuries | Mandibular ReconstructionTunisia