Postoperative Complication After Free Flap Reconstruction for Head and Neck Cancer
March 26, 2020 updated by: Chang Gung Memorial Hospital
The Impact of Operation Time and Operators on Postoperative Complication After Free Flap Reconstruction for Patients With Head and Neck Cancer
This study was designed to investigate the outcome of free-flap reconstruction surgery following head and neck cancer resection between primary and recurrent head and neck cancer patients.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2004
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
20 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
2,004 patients with head and neck cancer who underwent tumor wide excision and primary free flap reconstruction or secondary free flap reconstruction between March 2008 and February 2017.
After excluding missing or unvalidated data, 1,700 patients with a total of 1,791 free flap reconstructions (21 patients received double free flap reconstructions) was left in the study.
Description
Inclusion Criteria:
- Patients with head and neck cancer who underwent tumor wide excision and primary free flap reconstruction or secondary free flap reconstruction between March 2008 and February 2017
- Age: 20~100 years old
Exclusion Criteria:
- patients with missing or unvalidated data
- patients less than 20 years old
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
head and neck cancer with free flap reconstruction
patients with head and neck cancer who underwent tumor wide excision and primary free flap reconstruction or secondary free flap reconstruction between March 2008 and February 2017
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Patients with primary tumor which underwent free flap reconstruction group.
Patients with recurrent tumor which underwent free flap reconstruction group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Failure or success flap
Time Frame: 2 months after surgery
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The condition of the reconstruction flap is failure or success.
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2 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications
Time Frame: 2 months after surgery
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such as wound infection rate, fistula, hematoma, and partial necrosis of the flap
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2 months after surgery
|
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)
April 1, 2018
Primary Completion (Actual)
December 15, 2018
Study Completion (Actual)
March 31, 2019
Study Registration Dates
First Submitted
March 26, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 30, 2020
Study Record Updates
Last Update Posted (Actual)
March 30, 2020
Last Update Submitted That Met QC Criteria
March 26, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201800440B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.