Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 4
- 主要终点
- ASK Nasal symptom severity scores and SF-8 scores
研究概览
简要总结
This is a prospective, multi-center observational study designed to address patient-reported nasal outcomes in adults undergoing endoscopic and microscopic surgical removal of pituitary tumors. The primary objective of this study is to determine the difference in nasal outcomes by using the Anterior Skull Base (ASK) Nasal survey between patients treated with endoscopic surgical technique and those treated with microscopic surgical technique. Patients will be given the ASK Nasal survey to assess their nasal functioning and overall health before their surgery, and at post-operative visits 1-2 weeks, 3 months, and 6 months.
详细描述
The technical and patient factors that influence rhinological (nasal) outcomes following endonasal anterior skull base surgery and pituitary surgery are not well understood. Several timely and controversial topics, such as the influence of endoscopic techniques and the impact of underlying disease on nasal outcomes are in need of further study.
The Anterior Skull Base (ASK) Nasal survey is a 24-item questionnaire designed to assess for common postoperative nasal complaints, such as crusting, nasal congestion, pain, sinusitis, sense of smell, and overall functioning. The survey is a brief and simple assessment that asks patients to score symptom severity on a five-point scale.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pituitary tumor patients treated by transsphenoidal route
- •Adults (age 18-80 years)
- •Direct endonasal or endoscopic approach
- •Non-functioning adenoma, Cushing's disease, acromegaly
排除标准
- •Patients treated by expanded endonasal approaches (transtubercular approach)
- •Sublabial approach
结局指标
主要结局
ASK Nasal symptom severity scores and SF-8 scores
时间窗: 3 months
Compare symptom severity scores and quality of life scores in first-time surgery patients with nonfunctioning adenomas on the ASK Nasal and SF-8.
Validation of ASK Nasal survey tool
时间窗: 3 months
Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery.
次要结局
- ASK Nasal symptom severity scores(2 weeks, 3 months, 6 months postoperative)
- Impact of surgical techniques and complications on ASK Nasal scores(6 months)