Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428994
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-12
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:
Chang Gung Memorial Hospital
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 Jewers classification ischemia time number of fibula segments plate type re-exploration time of hospitalization postoperative radiotherapy andor 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 20220228 The investigators completed data analysis before 20220228 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?:
None