Surgical FlapsNCT06371365
Adverse Events for Free Flap Surgery in Head and Neck Cancer
An observational study of Surgical Flaps and Flap Failure Risk Factors, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Surgical Flaps, Flap Failure Risk Factors, Hematoma Risk Factors
- What is being tested?
- Free Flap surgery
- Type of treatment
- Surgery or procedure
- How many people
- 540 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Oct 2022to 24 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient greater than or equal to 20 years old who had free flap surgery following cancer ablation for head and neck cancer.
Who may be able to join
- Age greater and equal to 20 years old
- Underwent free flap surgery
- Had head and neck cancer
Who cannot join
- HIV positive
- Pregnant, breast feeing women
- Missing surgical charts
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this study
Official title: Prescription Pattern and Adverse Events of Postoperative Antithrombotic Regimes for Free Flap Surgery in Head and Neck Cancer
This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022.
Read the detailed description
Patient information are collected from the electronic medical records retrospectively:
Head and Neck cancer diagnosis: The International Classification of Diseases, Tenth Revision (ICD-10), which included C00-C14, C31, C32, C73, C75.0, C75.4 and C41.1.
The cancer stage, alcohol use, betel nut, and smoking, and baseline comorbidities.
Surgical characteristics including flap history, ablation time, reconstruction time, donor sites, recipient sites, neck dissection, flap size, anastomosis, artery types, vein types, intraoperative sealants used, and intravenous calcium channel blocker nicardipine to control hypertension after surgery.
- Being tested
- Free Flap surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Flap surgeryProcedure or surgery
No intervention, this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent free flap surgery | Not described Receives: Procedure: Free Flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with flap failure
Flap necrosis with a need for a new flap or other surgical procedures.
Measured: 30 days post-operation
Secondary outcomes (2)
Number of participants with hematoma
Surgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.
Measured: 30 days post-operation
Number of participants with thrombosis
Surgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.
Measured: 30 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start19 Oct 2022
- Primary completion24 Sep 2023
- Study completion24 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical FlapsStudies of the same condition, open and under way.
- 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
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying-Chi Lin, Kaohsiung Medical University
- Investigators
- Ying-Chi Lin, Ph.D., Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371365
- Sponsor's protocol ID
- KMUHIRB-E(II)-20220204
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsiung PH, Huang HY, Chen WY, Kuo YR, Lin YC. Cumulative risk factors for flap failure, thrombosis, and hematoma in free flap reconstruction for head and neck cancer: a retrospective nested case-control study. Int J Surg. 2024 Dec 1;110(12):7616-7623. doi: 10.1097/JS9.0000000000002069.
PubMed 39236088
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription Pattern and Adverse Events of Postoperative Antithrombotic Regimes for Free Flap Surgery in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06371365
- Acronym / sponsor ID
- KMUHIRB-E(II)-20220204
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Collaborators
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 17 Apr 2024 (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 is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022.
Detailed description
Patient information are collected from the electronic medical records retrospectively:
Head and Neck cancer diagnosis: The International Classification of Diseases, Tenth Revision (ICD-10), which included C00-C14, C31, C32, C73, C75.0, C75.4 and C41.1.
The cancer stage, alcohol use, betel nut, and smoking, and baseline comorbidities.
Surgical characteristics including flap history, ablation time, reconstruction time, donor sites, recipient sites, neck dissection, flap size, anastomosis, artery types, vein types, intraoperative sealants used, and intravenous calcium channel blocker nicardipine to control hypertension after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent free flap surgery | – | Procedure: Free Flap surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient greater than or equal to 20 years old who had free flap surgery following cancer ablation for head and neck cancer.
Key inclusion criteria (3 listed)
- Age greater and equal to 20 years old
- Underwent free flap surgery
- Had head and neck cancer
Key exclusion criteria (3 listed)
- HIV positive
- Pregnant, breast feeing women
- Missing surgical charts
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 |
|---|---|---|
| Free Flap surgeryNo intervention, this is an observational study | Procedure or surgery | Patients underwent free flap surgery |
Primary outcome
Number of participants with flap failure
Time frame: 30 days post-operation
Flap necrosis with a need for a new flap or other surgical procedures.
2 secondary outcomes
Number of participants with hematoma
Time frame: 30 days post-operation
Number of participants with thrombosis
Time frame: 30 days post-operation
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 18 Apr 2024.
- Derived from this study: PubMed 39236088Hsiung PH, Huang HY, Chen WY, Kuo YR, Lin YC. Cumulative risk factors for flap failure, thrombosis, and hematoma in free flap reconstruction for head and neck cancer: a retrospective nested case-control study. Int J Surg. 2024 Dec 1;110(12):7616-7623. doi: 10.1097/JS9.0000000000002069.
- 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.
Ying-Chi Lin, Ph.D. principal investigator
Kaohsiung Medical University
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 Surgical Flaps and Flap Failure Risk Factors, run by Kaohsiung Medical University 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 3 inclusion and 3 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 18 Apr 2024. 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?
Number of participants with flap failure (time frame: 30 days post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06371365, which also lists 1 linked publication.
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 18 Apr 2024.