A Clinical Trial to Study the Effects on the Olfaction Capacity of an Individual Undergoing Skull Base Surgeries Using Cautery vs Scalpel .

January 27, 2026 updated by: All India Institute of Medical Sciences, Jodhpur

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Rajasthan
      • Jodhpur, Rajasthan, India, 342005
        • Recruiting
        • All India Institute of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
During endoscopic endonasal skull base surgery,scalpel will be used to elevate the nasoseptal flap.
Procedure: Scalpel
During endoscopic endonasal skull base surgery,scalpel will be used to elevate the nasoseptal flap.
Active Comparator: Group B
During endoscopic endonasal skull base surgery,cautery will be used to elevate the nasoseptal flap.
Procedure: Cautery
During endoscopic endonasal skull base surgery,cautery will be used to elevate the nasoseptal flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperatively,Immediate postoperatively,3-6 months postoperatively
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)
Preoperatively,Immediately postoperatively,3-6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
22-item Sino Nasal Outcome Test (SNOT-22) questionnaire
Time Frame: Preoperatively,Immediate postoperatively,3-6 months postoperatively
It covers a range of sinonasal symptoms and their impact on social and emotional well-being
Preoperatively,Immediate postoperatively,3-6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Jodhpur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIIMS/IEC/2025/5462

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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