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

NCT07385911 | Recruiting

• 1 other identifier: AIIMS/IEC/2025/5462
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Olfaction

Outcome Measures

Primary Outcomes (2)

• Combined Olfactory Score (I-smell test)

  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)

  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 Outcomes (1)

• 22-item Sino Nasal Outcome Test (SNOT-22) questionnaire

  Preoperatively,Immediate postoperatively,3-6 months postoperatively

Study Arms (2)

Group A

EXPERIMENTAL

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

Procedure: Scalpel

Group B

ACTIVE COMPARATOR

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

Procedure: Cautery

Interventions

Scalpel PROCEDURE

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

Group A

Cautery PROCEDURE

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

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Jodhpur: lead

Study Sites (1)

All India Institute Of Medical Sciences

Jodhpur, Rajasthan, 342005, India

RECRUITING

Related Publications (3)

• Kim SW, Park KB, Khalmuratova R, Lee HK, Jeon SY, Kim DW. Clinical and histologic studies of olfactory outcomes after nasoseptal flap harvesting. Laryngoscope. 2013 Jul;123(7):1602-6. doi: 10.1002/lary.24107. Epub 2013 Mar 21.

  PMID: 23798331 RESULT

• Puccinelli CL, Yin LX, O'Brien EK, Van Gompel JJ, Choby GW, Van Abel KM, Janus JR, Stokken JK. Long-term olfaction outcomes in transnasal endoscopic skull-base surgery: a prospective cohort study comparing electrocautery and cold knife upper septal limb incision techniques. Int Forum Allergy Rhinol. 2019 May;9(5):493-500. doi: 10.1002/alr.22291. Epub 2019 Jan 18.

  PMID: 30657649 RESULT

• Hong SD, Nam DH, Park J, Kim HY, Chung SK, Dhong HJ. Olfactory outcomes after endoscopic pituitary surgery with nasoseptal "rescue" flaps: electrocautery versus cold knife. Am J Rhinol Allergy. 2014 Nov-Dec;28(6):517-9. doi: 10.2500/ajra.2014.28.4109.

  PMID: 25514489 RESULT

MeSH Terms

Conditions

Anosmia

Interventions

Laser Therapy; Cautery

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Ananya Srivastava, MBBS

CONTACT

+919672423734; ananyasrivastava1008@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: February 4, 2026
• Study Start: May 18, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

IN (1)