- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03346928
Free Flaps : Should we Propose Them to the Elderly ?
November 17, 2017 updated by: Hospices Civils de Lyon
Free Flaps for Head and Neck Reconstruction : Should we Propose Them to the Elderly
The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction.
A retrospective chart review of all patients undergoing head and neck free flap reconstruction was conducted and the overall hospital length of stay and the incidence of perioperative medical and surgical complications were assessed.
Study Type
Observational
Enrollment (Actual)
90
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
-
-
-
Lyon, France
- Croix-Rousse hospital, Hospices Civils de Lyon
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with head and neck cancer undergoing microsurgical free flap reconstruction
Description
Inclusion Criteria:
- Head and neck cancer
- Microsurgical free flap reconstruction
- 18 years of age or older
Exclusion Criteria:
-
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medical complications
Time Frame: One month post-surgery
|
Occurrence of medical complications within one month post-surgery
|
One month post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical complications
Time Frame: One month post-surgery
|
Occurrence of surgical complications within one month post-surgery
|
One month post-surgery
|
Hospital length of stay
Time Frame: Approximately 20 days
|
Approximately 20 days
|
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)
October 1, 2012
Primary Completion (Actual)
July 31, 2017
Study Completion (Actual)
July 31, 2017
Study Registration Dates
First Submitted
November 15, 2017
First Submitted That Met QC Criteria
November 17, 2017
First Posted (Actual)
November 20, 2017
Study Record Updates
Last Update Posted (Actual)
November 20, 2017
Last Update Submitted That Met QC Criteria
November 17, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC_GHN_2017_003
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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