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NCT06428994 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06428994
Other study ID # No. 201800172B0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date February 28, 2022

Study information
Verified date February 2018
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 580
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Radiation:
• Radiotherapy
Post-operative radiotherapy for head and neck cancer

Locations
Country Name City State
Taiwan Angela Chien-Yu Chen Taoyuan

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence on development osteoradionecrosis(ORN) in free fibula flaps The incidence of osteoradionecrosis in patients who received free fibula flap reconstruction Up to 7 years postoperatively
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