Reconstructive SurgeryNCT04002713
Comparison of Choosing Free ALT or Free PMT for Reconstruction With Head and Neck Cancer
An observational study of Reconstructive Surgery and Head and Neck Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Reconstructive Surgery, Head and Neck Cancer
- What is being tested?
- ALT flap reconstruction and AMT flap reconstruction
- How many people
- 1,590 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2019to 3 Jun 2019
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017.
Who cannot join
- Patients whose data were missing will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study was designed to compare the outcome of the anteromedial thigh (AMT) and anterolateral thigh (ALT) flaps in head and neck cancer reconstruction.
Read the 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.
- Conditions
- Reconstructive Surgery, Head and Neck Cancer
- Being tested
- ALT flap reconstruction, AMT flap reconstruction
- Keywords
- Anterolateral thigh (ALT), anteromedial thigh (AMT), free flap reconstruction, microsurgery, head and neck cancer, outcomes
- 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.
ALT flap reconstructionOther
Patients who underwent ALT free flap reconstruction after head and neck cancer surgery.
AMT flap reconstructionOther
Patients who underwent AMT free flap reconstruction after head and neck cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: ALT flap reconstruction; Other: AMT flap reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival or failure
The primary free flap outcome was determined as its survival or failure.
Measured: up to 6 months
Secondary outcomes (1)
Complications
The second outcome was the associated complications (fistula, hematoma, partial necrosis, and wound infection).
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start20 Mar 2019
- Primary completion2 May 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive SurgeryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002713
- Sponsor's protocol ID
- 201900308B0
- Status last verified
- Jun 2019
- First submitted
- 27 Jun 2019
- Last updated
- 1 Jul 2019
- 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 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04002713
- Acronym / sponsor ID
- 201900308B0
- Conditions
- Reconstructive Surgery, Head and Neck Cancer
- Keywords
- Anterolateral thigh (ALT), anteromedial thigh (AMT), free flap reconstruction, microsurgery, head and neck cancer, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,590 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 1 Jul 2019 (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.
This study was designed to compare the outcome of the anteromedial thigh (AMT) and anterolateral thigh (ALT) flaps in head and neck cancer 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALT&AMT free flap reconstruction | – | Other: ALT flap reconstruction, Other: AMT flap reconstructionPatients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017 |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017.
Key exclusion criteria (1 listed)
- Patients whose data were missing will be excluded.
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 |
|---|---|---|
| ALT flap reconstructionPatients who underwent ALT free flap reconstruction after head and neck cancer surgery. | Other | ALT&AMT free flap reconstruction |
| AMT flap reconstructionPatients who underwent AMT free flap reconstruction after head and neck cancer surgery. | Other | ALT&AMT free flap reconstruction |
Primary outcome
survival or failure
Time frame: up to 6 months
The primary free flap outcome was determined as its survival or failure.
1 secondary outcome
Complications
Time frame: up to 6 months
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 1 Jul 2019.
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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 Reconstructive Surgery and Head and Neck Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 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 1 Jul 2019. 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 Taiwan. 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?
survival or failure (time frame: up to 6 months). 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 1 Jul 2019.