Head and Neck CancerNCT04326088
Postoperative Complication After Free Flap Reconstruction for Head and Neck Cancer
An observational study of Head and Neck Cancer and Recurrent Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Head and Neck Cancer, Recurrent Cancer, Surgery--Complications
- What is being tested?
- Reconstruction group and Recurrent group
- How many people
- 2,004 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2018to 31 Mar 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: 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.
Who may be able to join
- 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
Who cannot join
- patients with missing or unvalidated data
- patients less than 20 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Reconstruction group, Recurrent group
- Medical subject headings
- Head and Neck Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction groupOther
Patients with primary tumor which underwent free flap reconstruction group.
Recurrent groupOther
Patients with recurrent tumor which underwent free flap reconstruction group.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Reconstruction group; Other: Recurrent group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure or success flap
The condition of the reconstruction flap is failure or success.
Measured: 2 months after surgery
Secondary outcomes (1)
Complications
such as wound infection rate, fistula, hematoma, and partial necrosis of the flap
Measured: 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Apr 2018
- Primary completion15 Dec 2018
- Study completion31 Mar 2019
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 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
- 2,004 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
- NCT04326088
- Sponsor's protocol ID
- 201800440B0
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Operation Time and Operators on Postoperative Complication After Free Flap Reconstruction for Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04326088
- Acronym / sponsor ID
- 201800440B0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,004 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 30 Mar 2020 (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 investigate the outcome of free-flap reconstruction surgery following head and neck cancer resection between primary and recurrent head and neck cancer patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| head and neck cancer with free flap reconstruction | – | Other: Reconstruction group, Other: Recurrent grouppatients 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 |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- patients with missing or unvalidated data
- patients less than 20 years old
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 |
|---|---|---|
| Reconstruction groupPatients with primary tumor which underwent free flap reconstruction group. | Other | head and neck cancer with free flap reconstruction |
| Recurrent groupPatients with recurrent tumor which underwent free flap reconstruction group. | Other | head and neck cancer with free flap reconstruction |
Primary outcome
Failure or success flap
Time frame: 2 months after surgery
The condition of the reconstruction flap is failure or success.
1 secondary outcome
Complications
Time frame: 2 months after surgery
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 30 Mar 2020.
- Individual participant dataSharing planned: No
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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 and Recurrent 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 2 inclusion and 2 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 30 Mar 2020. 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?
Failure or success flap (time frame: 2 months after 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 30 Mar 2020.