Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002713
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment
Reconstructive Surgery Head and Neck Cancer Other: ALT flap reconstruction Other: AMT flap reconstruction

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1590 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : May 2, 2019
Actual Study Completion Date : June 3, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. survival or failure [ Time Frame: up to 6 months ]
    The primary free flap outcome was determined as its survival or failure.


Secondary Outcome Measures :
  1. Complications [ Time Frame: up to 6 months ]
    The second outcome was the associated complications (fistula, hematoma, partial necrosis, and wound infection).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002713


Locations
Layout table for location information
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
Sponsors and Collaborators
Chang Gung Memorial Hospital
Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04002713    
Other Study ID Numbers: 201900308B0
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
Anterolateral thigh (ALT)
anteromedial thigh (AMT)
free flap reconstruction
microsurgery
head and neck cancer
outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms