A Clinical Trial to Study the Effects on the Olfaction Capacity of an Individual Undergoing Skull Base Surgeries Using Cautery vs Scalpel .
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Scalpel, Cautery.
- Who it may be relevant to
- Registry conditions: Olfaction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Olfactory Outcomes of Cautery Vs Scalpel in Endoscopic Endonasal Skull Base Surgery- A Prospective Randomised Controlled Study.
Overview
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
- Procedure Scalpel
During endoscopic endonasal skull base surgery,scalpel will be used to elevate the nasoseptal flap. - Procedure Cautery
During endoscopic endonasal skull base surgery,cautery will be used to elevate the nasoseptal flap.
Primary outcome measures
- Combined Olfactory Score (I-smell test) [Time frame: Preoperatively,Immediate postoperatively,3-6 months postoperatively]
- Visual Analogue Scale (VAS) [Time frame: Preoperatively,Immediately postoperatively,3-6 months postoperatively]
Secondary outcome measures (1)
- 22-item Sino Nasal Outcome Test (SNOT-22) questionnaire [Time frame: Preoperatively,Immediate postoperatively,3-6 months postoperatively]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- All India Institute Of Medical Sciences — Jodhpur
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT07385911 · AIIMS/IEC/2025/5462