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

Completed

• Conditions: Head and Neck Cancer; Fibula Flap; Osteoradionecrosis; Mandibulectomy
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT06428994
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2018-02
• Study Start: 2019-03-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Study First Submitted: 2024-05-12
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ORN	Radiotherapy	ORN in this study is defined as exposed irradiated bone tissue that fails to heal over a period of three months without residual or recurrent tumors.

Primary Outcome Measures

Name	Time	Method
The incidence on development osteoradionecrosis(ORN) in free fibula flaps	Up to 7 years postoperatively	The incidence of osteoradionecrosis in patients who received free fibula flap reconstruction

Trial Locations

Locations (1)

Angela Chien-Yu Chen; 🇨🇳 Taoyuan, Taiwan