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NCT Number: NCT07385911

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute Of Medical Sciences

Jodhpur, Rajasthan, 342005, India

Location status: Recruiting

Location contact

Jaskaran Singh Gosal

CONTACT

[email protected]

+91 6283-475891

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scalpel

Procedure

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

Cautery

Procedure

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

Primary outcomes

  1. 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.

  2. 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

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ananya Srivastava, MBBS

CONTACT

[email protected]

+919672423734

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Jodhpur

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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