Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-05 @ 1:51 PM
Study NCT ID:
NCT06428994
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
Official Title:
Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: