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Clinical Trials/NCT07385911
NCT07385911
Recruiting
Not Applicable

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

All India Institute of Medical Sciences, Jodhpur1 site in 1 country80 target enrollmentStarted: May 18, 2025Last updated:
InterventionsScalpelCautery

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
All India Institute of Medical Sciences, Jodhpur
Enrollment
80
Locations
1
Primary Endpoint
Combined Olfactory Score (I-smell test)

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing endoscopic endonasal skull base surgeries that require the raising of a nasoseptal flap

Exclusion Criteria

  • 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

Arms & Interventions

Group A

Experimental

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

Intervention: Scalpel (Procedure)

Group B

Active Comparator

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

Intervention: Cautery (Procedure)

Outcomes

Primary Outcomes

Combined Olfactory Score (I-smell test)

Time Frame: 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)

Time Frame: Preoperatively,Immediately postoperatively,3-6 months postoperatively

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

Secondary Outcomes

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

Investigators

Sponsor
All India Institute of Medical Sciences, Jodhpur
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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