Head and Neck CancerNCT03346928
Free Flaps : Should we Propose Them to the Elderly ?
An observational study of Head and Neck Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Head and neck reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2012to 31 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with head and neck cancer undergoing microsurgical free flap reconstruction
Who may be able to join
- Head and neck cancer
- Microsurgical free flap reconstruction
- 18 years of age or older
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Head and neck reconstruction
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head and neck reconstructionProcedure or surgery
Head and neck free flap reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical complications
Occurrence of medical complications within one month post-surgery
Measured: One month post-surgery
Secondary outcomes (2)
Surgical complications
Occurrence of surgical complications within one month post-surgery
Measured: One month post-surgery
Hospital length of stay
Measured: Approximately 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Oct 2012
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346928
- Sponsor's protocol ID
- CRC_GHN_2017_003
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Flaps for Head and Neck Reconstruction : Should we Propose Them to the Elderly
- ClinicalTrials.gov ID
- NCT03346928
- Acronym / sponsor ID
- CRC_GHN_2017_003
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck cancer undergoing microsurgical free flap reconstruction
Key inclusion criteria (3 listed)
- Head and neck cancer
- Microsurgical free flap reconstruction
- 18 years of age or older
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head and neck reconstructionHead and neck free flap reconstruction | Procedure or surgery | – |
Primary outcome
Medical complications
Time frame: One month post-surgery
Occurrence of medical complications within one month post-surgery
2 secondary outcomes
Surgical complications
Time frame: One month post-surgery
Hospital length of stay
Time frame: Approximately 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical complications (time frame: One month post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.