A Clinical Trial to Study the Effects on the Olfaction Capacity of an Individual Undergoing Skull Base Surgeries Using Cautery vs Scalpel .
Recruiting now · Not applicable
Conditions studied: Olfaction
In brief
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.
Key facts
- Study ID
- NCT07385911
- Run by
- All India Institute of Medical Sciences, Jodhpur
- People needed
- 80
- Starts
- 2025-05-18
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2026-02-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- All India Institute Of Medical Sciences — Jodhpur, Rajasthan, India (enrolling)
Full record on ClinicalTrials.gov
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