OlfactionNCT07385911
A Clinical Trial to Study the Effects on the Olfaction Capacity of an Individual Undergoing Skull Base Surgeries Using Cautery vs Scalpel .
A study testing Scalpel and Cautery in people with Olfaction, run by All India Institute of Medical Sciences, Jodhpur at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olfaction
- What is being tested?
- Scalpel and Cautery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 18 May 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients undergoing endoscopic endonasal skull base surgeries that require the raising of a nasoseptal flap
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
All India Institute Of Medical Sciences
Jodhpur, Rajasthan, 342005
Jaskaran Singh Gosal, +91 6283-475891, jhsgosal_87@hotmail.com
About this study
Official title: Olfactory Outcomes of Cautery Vs Scalpel in Endoscopic Endonasal Skull Base Surgery- A Prospective Randomised Controlled Study.
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.
- Conditions
- Olfaction
- Being tested
- Scalpel, Cautery
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScalpelProcedure or surgery
During endoscopic endonasal skull base surgery,scalpel will be used to elevate the nasoseptal flap.
CauteryProcedure or surgery
During endoscopic endonasal skull base surgery,cautery will be used to elevate the nasoseptal flap.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | During endoscopic endonasal skull base surgery,scalpel will be used to elevate the nasoseptal flap. Receives: Procedure: Scalpel |
| Group B | Active comparator | During endoscopic endonasal skull base surgery,cautery will be used to elevate the nasoseptal flap. Receives: Procedure: Cautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Olfactory Score (I-smell test)
Threshold odour identification score and specific odour identification score will be added to form a Combined Olfactory Score.
Measured: Preoperatively,Immediate postoperatively,3-6 months postoperatively
Visual Analogue Scale (VAS)
Visual analogue scale scoring from 0-10 to measure olfaction. (with higher score indicating better olfaction capacity)
Measured: 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
Measured: Preoperatively,Immediate postoperatively,3-6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start18 May 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OlfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Jodhpur
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385911
- Sponsor's protocol ID
- AIIMS/IEC/2025/5462
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 23798331Puccinelli 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 30657649Hong 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Outcomes of Cautery Vs Scalpel in Endoscopic Endonasal Skull Base Surgery- A Prospective Randomised Controlled Study.
- ClinicalTrials.gov ID
- NCT07385911
- Acronym / sponsor ID
- AIIMS/IEC/2025/5462
- Conditions
- Olfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, JodhpurOther government
- Study start
- 18 May 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: ScalpelDuring endoscopic endonasal skull base surgery,scalpel will be used to elevate the nasoseptal flap. |
| Group B | Active comparator | Procedure: CauteryDuring endoscopic endonasal skull base surgery,cautery will be used to elevate the nasoseptal flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients undergoing endoscopic endonasal skull base surgeries that require the raising of a nasoseptal flap
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScalpelDuring endoscopic endonasal skull base surgery,scalpel will be used to elevate the nasoseptal flap. | Procedure or surgery | Group A |
| CauteryDuring endoscopic endonasal skull base surgery,cautery will be used to elevate the nasoseptal flap. | Procedure or surgery | Group B |
Primary outcome
Combined Olfactory Score (I-smell test)
Time frame: Preoperatively,Immediate postoperatively,3-6 months postoperatively
Threshold odour identification score and specific odour identification score will be added to form a Combined Olfactory Score.
Visual Analogue Scale (VAS)
Time frame: Preoperatively,Immediately postoperatively,3-6 months postoperatively
Visual analogue scale scoring from 0-10 to measure olfaction. (with higher score indicating better olfaction capacity)
1 secondary outcome
22-item Sino Nasal Outcome Test (SNOT-22) questionnaire
Time frame: Preoperatively,Immediate postoperatively,3-6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Results publication: PubMed 23798331Kim 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.
- Results publication: PubMed 30657649Puccinelli 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.
- Results publication: PubMed 25514489Hong 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.
Related trials for Olfaction
Active, not recruiting
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingObservational study
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Hearing Loss, Deafness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalpel and Cautery in people with Olfaction, run by All India Institute of Medical Sciences, Jodhpur at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ananya Srivastava, MBBS (+919672423734, ananyasrivastava1008@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Olfactory Score (I-smell test) (time frame: Preoperatively,Immediate postoperatively,3-6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07385911, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.