Cautery versus scalpel: effects on sense of smell after skull base surgery
Olfactory Outcomes of Cautery Vs Scalpel in Endoscopic Endonasal Skull Base Surgery- A Prospective Randomised Controlled Study.
This trial will test whether using cautery or a scalpel during endoscopic skull-base surgery changes patients' sense of smell.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences, Jodhpur Government |
| Locations | 1 site (Jodhpur, Rajasthan) |
| Trial ID | NCT07385911 on ClinicalTrials.gov |
What this trial studies
This interventional study compares olfactory outcomes after nasoseptal flap elevation performed with cautery versus a scalpel in patients undergoing endoscopic endonasal skull base surgery. Participants will have formal smell testing before surgery and again after surgery to measure any change in olfactory function. Patients with preexisting anosmia, prior sinonasal or skull base operations, neurodegenerative disease, or chronic rhinosinusitis are excluded to isolate the effect of the surgical technique. The goal is to determine whether one technique better preserves the olfactory neuroepithelium and patients' smell function.
Who should consider this trial
Good fit: Adults scheduled for endoscopic endonasal skull base surgery that requires raising a nasoseptal flap and who do not have preoperative anosmia, prior sinonasal/pituitary/skull base surgery, neurodegenerative disease, or chronic rhinosinusitis are ideal candidates.
Not a fit: Patients with preoperative anosmia, previous sinonasal or skull base surgery, neurodegenerative disease, or chronic rhinosinusitis are excluded and would not be expected to benefit from this comparison.
Why it matters
Potential benefit: If successful, the results could guide surgeons to use the technique that better preserves smell, reducing postoperative loss of olfaction.
How similar studies have performed: Prior research indicates that surgical technique can affect smell after endonasal approaches, but direct comparisons of cautery versus scalpel for olfaction are limited, making this a relatively novel direct comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jodhpur, Rajasthan
- All India Institute Of Medical Sciences — Jodhpur, Rajasthan, India (Recruiting)
Study contacts
- Study coordinator: Ananya Srivastava, MBBS
- Email: ananyasrivastava1008@gmail.com
- Phone: +919672423734
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.