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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07385911
Enrollment
80
Registered
2026-02-04
Start date
2025-05-18
Completion date
2026-08-31
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Olfaction

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.

Interventions

PROCEDUREScalpel

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

PROCEDURECautery

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

Sponsors

All India Institute of Medical Sciences, Jodhpur
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Combined Olfactory Score (I-smell test)Preoperatively,Immediate postoperatively,3-6 months postoperativelyThreshold odour identification score and specific odour identification score will be added to form a Combined Olfactory Score.
Visual Analogue Scale (VAS)Preoperatively,Immediately postoperatively,3-6 months postoperativelyVisual analogue scale scoring from 0-10 to measure olfaction. (with higher score indicating better olfaction capacity)

Secondary

MeasureTime frameDescription
22-item Sino Nasal Outcome Test (SNOT-22) questionnairePreoperatively,Immediate postoperatively,3-6 months postoperativelyIt covers a range of sinonasal symptoms and their impact on social and emotional well-being

Countries

India

Contacts

CONTACTAnanya Srivastava, MBBS
ananyasrivastava1008@gmail.com+919672423734

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026