Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique
试验速览
- 阶段
- 不适用
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Functional Assessment of Cancer Therapy: General (FACT-G)
研究概览
简要总结
Prospective monocentric quality of life study. Including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone.
The sponsor will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires.
详细描述
It is now obvious to all surgeons involved in the follow-up of these patients that not all orbital reconstruction techniques are equal.
Thus, through this study, The investigators wish to objectively highlight the gain in quality of life and prosthetic equipment in exentered patients, depending on the reconstruction method used.
This prospective study, including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposes to compare the reported quality of life of patients according to the reconstruction technique patients have undergone.
The investigators will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires. The investigators will submit them, after express telephone agreement, by post to all the patients included in our study.
The aim of such a study will therefore be to provide assistance to both surgeons and patients in the choice of an orbital reconstruction technique, by objectively demonstrating the superiority of one technique over the others in terms of quality of life and prosthetic equipment rate.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients, living or lost, exentered at the Institut Curie Paris between January 2014 and December 2019,
排除标准
- •Persons under court protection.
- •Persons not in a condition to give their consent.
结局指标
主要结局
Functional Assessment of Cancer Therapy: General (FACT-G)
时间窗: Baseline
The FACT-G questionnaire consists of 27 general items, with the patient scoring each item on a scale of 0 to 4. The final score is the sum of all the items.
FACT/McGill Body Image Concern Scale - Head and Neck Cancer Version (FACT-MBIS)
时间窗: Baseline
The FACT-MBIS questionnaire consists of 21 items related to self-esteem and social comfort, each item is also scored on a scale of 0 to 4. The final score is the sum of all items.
次要结局
未报告次要终点