跳至主要内容
临床试验/CTRI/2025/05/086957
CTRI/2025/05/086957
尚未招募
Post Marketing Surveillance

Olfactory outcomes of Cautery Vs Scalpel in Endoscopic Endonasal Skull BaseSurgery- A Prospective Randomised Controlled Study.

AIIMS 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25日最近更新:

概览

阶段
Post Marketing Surveillance
状态
尚未招募
发起方
AIIMS Jodhpur
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)

研究者

发起方
AIIMS Jodhpur
申办方类型
Research institution and hospital

研究点 (1)

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