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临床试验/NCT07385911
NCT07385911招募中不适用

Olfactory Outcomes of Cautery Vs Scalpel in Endoscopic Endonasal Skull Base Surgery- A Prospective Randomised Controlled Study.

All India Institute of Medical Sciences, Jodhpur1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年5月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Combined Olfactory Score (I-smell test)

研究概览

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
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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

研究组 & 干预措施

Group A

Experimental

During endoscopic endonasal skull base surgery,scalpel will be used to elevate the nasoseptal flap.

干预措施: Scalpel (Procedure)

Group B

Active Comparator

During endoscopic endonasal skull base surgery,cautery will be used to elevate the nasoseptal flap.

干预措施: Cautery (Procedure)

结局指标

主要结局

Combined Olfactory Score (I-smell test)

时间窗: Preoperatively,Immediate postoperatively,3-6 months postoperatively

Threshold odour identification score and specific odour identification score will be added to form a Combined Olfactory Score.

Visual Analogue Scale (VAS)

时间窗: Preoperatively,Immediately postoperatively,3-6 months postoperatively

Visual analogue scale scoring from 0-10 to measure olfaction. (with higher score indicating better olfaction capacity)

次要结局

  • 22-item Sino Nasal Outcome Test (SNOT-22) questionnaire(Preoperatively,Immediate postoperatively,3-6 months postoperatively)

研究者

发起方
All India Institute of Medical Sciences, Jodhpur
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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