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

NCT06428994 | Completed

• 1 other identifier: No. 201800172B0
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Fibula Flap; Osteoradionecrosis; Mandibulectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ORN

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.

Radiation: Radiotherapy

non-ORN

Patients without ORN.

Interventions

Radiotherapy RADIATION

Post-operative radiotherapy for head and neck cancer

ORN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between January 2014 and December 2019, 580 patients received free fibula flap mandibular reconstruction, with 374 of them attributed to head and neck cancer reconstruction. Cases with incomplete medical records were excluded (n = 9). Additionally, patients who did not attend at least 6 months of follow-up were also excluded (n = 36). Finally, 329 patients including 309 males and 20 females met the inclusion criteria of this study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Angela Chien-Yu Chen

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Osteoradionecrosis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 24, 2024
• Study Start: March 1, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 24, 2024

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)