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Clinical Trials/NCT06428994
NCT06428994
Completed
Not Applicable

Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study

Chang Gung Memorial Hospital1 site in 1 country580 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Chang Gung Memorial Hospital
Enrollment
580
Locations
1
Primary Endpoint
The incidence on development osteoradionecrosis(ORN) in free fibula flaps
Status
Completed
Last Updated
last year

Overview

Brief Summary

A retrospective analysis of 329 patients at one single institution between January 2014 and December 2019 who underwent free fibula flap reconstruction was conducted. A variety of clinicopathological postoperative parameters were identified and assessed.

Detailed Description

The study was conducted as a monocentric, retrospective study. Patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through January 2014 to December 2019 at one single institution in Taiwan were identified. All charts including surgical records, progress notes, nursing records, clinic notes, imaging study after surgery were reviewed. Data extraction was performed for the following variables: Patient demographics, primary diagnosis, cancer location and staging, treatment prior to index surgery, postoperative hemoglobin and albumin, operating time, flap type, mandibular defect length, type of the defect according to Jewer's classification, ischemia time, number of fibula segments, plate type, re-exploration, time of hospitalization, postoperative radiotherapy and/or chemotherapy, ORN cases, identification time of ORN and management for ORN. The patients were then organized into two groups: ORN and non-ORN. This research was approved by the Institutional Review Board of our hospital (No. 201800172B0), which was available until 2022/02/28. The investigators completed data analysis before 2022/02/28 and then initiated manuscript preparing.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
February 28, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through January 2014 to December 2019.

Exclusion Criteria

  • Cases with incomplete medical records.
  • Patients who did not attend at least 6 months of follow ups.

Outcomes

Primary Outcomes

The incidence on development osteoradionecrosis(ORN) in free fibula flaps

Time Frame: Up to 7 years postoperatively

The incidence of osteoradionecrosis in patients who received free fibula flap reconstruction

Study Sites (1)

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