ClinicalTrials.gg
RecruitingNCT07385911Updated Oct 30, 2026

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

An interventional study of Scalpel and Cautery in Olfaction, sponsored by All India Institute of Medical Sciences, Jodhpur. Recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by All India Institute of Medical Sciences, Jodhpur · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled May 2025, registered Dec 2025).
  • Started May 2025; still recruiting 1 year 5 months later.
Updated Oct 30, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Olfaction

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03

In context

Anosmia

180 studies on the registry are indexed under Anosmia; 45 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 114 interventional studies indexed under Anosmia.

Browse Anosmia studies →

Lead sponsor

All India Institute of Medical Sciences, Jodhpur is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-Patients undergoing endoscopic endonasal skull base surgeries that require the raising of a nasoseptal flap

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Group A

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

    Procedure: Scalpel

  • Active comparator
    Group B

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

    Procedure: Cautery

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.

06

What researchers measure

Primary outcomes

  1. Combined Olfactory Score (I-smell test)

    Threshold odour identification score and specific odour identification score will be added to form a Combined Olfactory Score.

    Time frame: Preoperatively,Immediate postoperatively,3-6 months postoperatively

  2. Visual Analogue Scale (VAS)

    Visual analogue scale scoring from 0-10 to measure olfaction. (with higher score indicating better olfaction capacity)

    Time frame: Preoperatively,Immediately postoperatively,3-6 months postoperatively

Secondary outcomes

  1. 22-item Sino Nasal Outcome Test (SNOT-22) questionnaire

    It covers a range of sinonasal symptoms and their impact on social and emotional well-being

    Time frame: Preoperatively,Immediate postoperatively,3-6 months postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 25514489 ↗
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Jan 2027, 20 months after the start.

Of 50 non-industry interventional studies with no phase under Anosmia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's planned 20 months is below that.

Counting every sponsor, half of 50 studies reached it within 28 months; a quarter within 14 and three quarters within 37.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Aug 2026 → Jan 2027 and completion Aug 2026 → Jan 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2025
First posted
Feb 4, 2026
StartActual
May 18, 2025
Primary completionEst.
Jan 31, 2027was Aug 2026
CompletionEst.
Jan 31, 2027was Aug 2026
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 31, 2026→Jan 31, 2027
Oct 30, 2026
Study completion
Aug 31, 2026→Jan 31, 2027
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Primary completion Aug 31, 2026→Jan 31, 2027
    Study completion Aug 31, 2026→Jan 31, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07385911
Lead sponsor
All India Institute of Medical Sciences, Jodhpur
Responsible party
Sponsor
First posted
Feb 4, 2026
Start date
May 18, 2025
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Ananya Srivastava, MBBS
Contact
ananyasrivastava1008@gmail.com
+919672423734

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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