Adverse Events for Free Flap Surgery in Head and Neck Cancer | NCT06371365

Studies
Adverse Events for Free Flap Surgery in Head and Neck Cancer

NCT06371365

Sponsor

Kaohsiung Medical University

Status

Completed

Last Update Posted

Apr 18, 2024Actual

Enrollment

540Actual

Phase

Not provided

Conditions

Surgical Flaps
Flap Failure Risk Factors
Hematoma Risk Factors
Thrombosis Risk Factors

Interventions

Free Flap surgery

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 19, 2022Actual

Primary Completion Date

Sep 24, 2023Actual

Completion Date

Sep 24, 2023Actual

First Submitted Date

Apr 9, 2024

First Submission Date that Met QC Criteria

Apr 12, 2024

First Posted Date

Apr 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ying-Chi Lin, Director, Master Degree Program in Toxicology, Kaohsiung Medical UniversityPrincipal Investigator

Lead Sponsor

Kaohsiung Medical UniversityOTHER

Collaborators

Name	Class
Kaohsiung Medical University Chung-Ho Memorial Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

540Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients underwent free flap surgery			Procedure: Free Flap surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Free Flap surgery	Procedure	No intervention, this is an observational study	Patients underwent free flap surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with flap failure	Flap necrosis with a need for a new flap or other surgical procedures.	30 days post-operation

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with hematoma	Surgical indication for reoperation. Reoperation is performed when patients experienced major complications refractory to bedside management.	30 days post-operation
Number of participants with thrombosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater and equal to 20 years old
Underwent free flap surgery
Had head and neck cancer

Exclusion Criteria:

HIV positive
Pregnant, breast feeing women
Missing surgical charts

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ying-Chi Lin, Ph.D.	Kaohsiung Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Medical University Chung-Ho Memorial Hospital		Kaohsiung City			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39236088	Derived	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.