A Prospective Longitudinal Quality of Life Study in Patients Undergoing Endoscopic Endonasal Skull Base Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries.
研究概览
简要总结
This is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base.
详细描述
This is a prospective single-institution longitudinal study to access quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base. Patients will be followed before surgery and up to twenty-four months post-surgery. The primary goal of the study is to assess the alterations to patient quality of life following endoscopic endonasal surgery using modern sinonasal reconstruction techniques. Secondary goals are to better understand the time course of normal healing and patient/procedural risk factors associated with poorer quality of life outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is scheduled to undergo endoscopic endonasal surgery. Multiple, staged surgeries are not exclusionary
- •18 years of age or older
- •The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
排除标准
- •Patient is a prisoner
- •Patient is not English speaking
- •Patient is not expected to survive until the 2-year follow-up
结局指标
主要结局
PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries.
时间窗: 24-months post-operatively
This study aims to better understand the long-term overall quality of life of patients undergoing endoscopic endonasal surgery using modern sinonasal reconstruction techniques. The PROMIS-29 metric, an overall quality of life metric, will be used to better understand quality of life for patients undergoing this procedure.
次要结局
- ASK Nasal-12 questionnaire used to measure normal time of healing for patients undergoing endoscopic endonasal surgery(24 months post-operatively)
- Number of patients with long-term quality of life risk factors using PROMIS-29(24 months post-operatively)
- Number of patients with long-term procedural comorbidities using ASK-Nasal 12.(24 months post-operatively)
研究者
Kyle Wu
Assistant Professor, Neurological Surgery
Ohio State University