Numerical Simulation Analysis of Nasal Physiology After Endoscopic Pituitary Surgery.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Airflow patterns.
研究概览
简要总结
The aim of this study is to determine the impact of endoscopic transsphenoidal pituitary surgery on nasal function using a numerical simulation and to compare the difference between two kinds of transsphenoidal approachese(single nostril approach and bilateral nostril approach)．
详细描述
Neuroendoscopic surgery is the first treatment for most pituitary adenoma patients. Because transsphenoidal surgery exploits the nasal corridor and paranasal sinuses to reach the skull base, sinonasal trauma is a primary source of postoperative morbidity in many of these patients. The aim of this study is to determine the impact of endoscopic transsphenoidal pituitary surgery on nasal function using a numerical simulation and to compare the difference between two kinds of transsphenoidal approachese(single nostril approach and bilateral nostril approach)．
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enhanced MRI shows a pituitary tumor
- •Endoscopic surgery is required according to the pituitary tumor treatment guidelines.
- •Karnofsky performance status ≥
- •The patient has signed the informed consent.
排除标准
- •Patients who have undergone previous transsphenoidal surgery or other nasal surgery.
- •Patients who had a history of nasal tumors.
- •Patients who had a history of severe head or face trauma.
- •Patients with congenital sinus malformation.
- •Pregnant or lactating women.
- •Patients with serious systemic diseases without control.
- •Patients with poor compliance, who cannot implement the program strictly.
结局指标
主要结局
Airflow patterns.
时间窗: Up to 3 months
A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal airflow patterns 3 months after surgery.
Nasal airway patency.
时间窗: Up to 3 months
A bilateral model of the human nose on a CT-scan will be reconstructed to display geometric parameters of nasal cavity 3 months after surgery.
Temperature parameter.
时间窗: Up to 3 months
A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal temperature parameter 3 months after surgery.
Humidity parameter.
时间窗: Up to 3 months
A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal humidity parameter 3 months after surgery.
CT Lund-Mackay Score
时间窗: Up to 3 months
Record the CT Lund-Mackay Score 3 months after surgery.The CT Lund-Mackay Score has a maximum score of 24 and a minimum score of 0. Higher values represent a worse outcome.
SNOT-20
时间窗: Up to 3 months
Record the Sino-Nasal Outcome Record the Test-20(SNOT-20) 3 months after surgery. The SNOT-20 has a maximum score of 60 and a minimum score of 0. Higher values represent a worse outcome.
VAS
时间窗: Up to 3 months
Record the Visual Analogue Scale(VAS) 3 months after surgery. The VAS scale includes six sub-scales: rhinorrhea VAS, rhinobyon VAS，rhinocnesmus VAS, cough VAS, sneezing VAS and olfaction VAS. Each scale has a maximum score of 10 and a minimum score of 0. The total VAS was the average of all sub-scales. Higher values represent a better outcome.
SF-36
时间窗: Up to 3 months
Record the Medical Outcome Study Short Form 36-items Health survey(SF-36) 3 months after surgery. The SF-36 includes six sub-scales: General Health, Reported Health Transition，Physical Functioning, Role-Physical, Role-Emotional, Social Functioning, Bodily Pain, Vitality and Mental Health. Each scale has a maximum score of 100 and a minimum score of 0. The total score was the average of all sub-scales. Higher values represent a better outcome.
次要结局
- Temperature parameter.(1 week after surgery)
- Nasal airway patency.(1 week after surgery)
- Change on Tumor(Up to 3 months)
- Airflow patterns.(1 week after surgery)
- Humidity parameter.(1 week after surgery)
- SF-36(1 week after surgery)
- VAS(1 week after surgery)
- SNOT-20(1 week after surgery)
- CT Lund-Mackay Score(1 week after surgery)
研究者
Zhebao Wu
Professor
Ruijin Hospital