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临床试验/NCT06428994
NCT06428994已完成不适用

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

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 580 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
580
试验地点
1
主要终点
The incidence on development osteoradionecrosis(ORN) in free fibula flaps

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

The incidence on development osteoradionecrosis(ORN) in free fibula flaps

时间窗: Up to 7 years postoperatively

The incidence of osteoradionecrosis in patients who received free fibula flap reconstruction

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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