Olfactory outcomes of Cautery Vs Scalpel in Endoscopic Endonasal Skull BaseSurgery- A Prospective Randomised Controlled Study.
概览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Olfaction assessment using g I-smell tests, VAS scale
概览
简要总结
Olfaction is a prominent entity that determines a person’s quality of life. During human evolution, olfaction has played an essential role in determining safe food, assessing threats, and developing social relationships. Endoscopic endonasal surgeries are widely used today for the removal of brain tumors involving the pituitary and skull base. The minimal invasiveness, rapid recovery, better visualization, and lower occurrence of complication make endonasal endoscopic surgery an ideal approach for tumors involving the pituitary and midline skull base. However, the olfactory epithelium is at risk of injury during endoscopic skull base surgeries due to the orientation of the olfactory epithelium fibers.It has been found that the olfactory neuroepithelium extends from the cribriform plate superiorly to the septum for the superior-most 1 to 2 cm medially and onto the upper half of the superior turbinates laterally.It also extends from the face of the sphenoid posteriorly to the attachment of the middle turbinate anteriorly.This makes the olfactory fibers susceptible to injury during endonasal surgery that requires superior or upper limb septal incisions, such as the pedicled nasoseptal flap (the Hadad-Bassagasteguy flap) and modified nasoseptal rescue flap.It has been debated whether using a scalpel instead of cautery could have a differential effect on the olfaction of an individual, as some surgeons believe that the heat generated by a cautery injures the nearby olfactory mucosa.This study aims at determining the method which is better at preserving the olfactory capacity of an individual undergoing endoscopic endonasal skull base surgery.
研究设计
- 研究类型
- Pms
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients undergoing endoscopic endonasal skull base surgeries that require the raising of a nasoseptal flap.
排除标准
- •Patients with preoperative anosmia due to any cause.
- •Patients with a previous history of sino-nasal, pituitary, or skull base surgery.
- •Patients with a medical history of neurodegenerative diseases (for example, Alzheimer’s disease or Parkinson’s disease), chronic rhinosinusitis.
结局指标
主要结局
Olfaction assessment using g I-smell tests, VAS scale
时间窗: Preoperatively,Immediate Postoperatively,3-6 months following surgery
次要结局
- Other sinonasal outcome assessment using SNOT 22 questionnaire(Preoperatively,Immediate postoperatively,3-6 months following surgery)