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

Chang Gung Medical Foundation

Status: Completed

Conditions: Mandibulectomy; Osteoradionecrosis; Fibula Flap; Head and Neck Cancer

Treatments: Radiation: Radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06428994

No. 201800172B0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 580 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

580 participants in 2 patient groups

ORN

Description:

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.

Treatment:

Radiation: Radiotherapy

non-ORN

Description:

Patients without ORN.