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

All India Institute of Medical Sciences, Jodhpur

Status: Enrolling

Conditions: Olfaction

Treatments: Procedure: Cautery; Procedure: Scalpel

Study type: Interventional

Funder types: Other

Identifiers

NCT07385911

AIIMS/IEC/2025/5462

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Procedure: Scalpel

Group B

Active Comparator group

Description:

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

Treatment:

Procedure: Cautery