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CTRI Number  CTRI/2025/05/086957 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On: 14/05/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects on the olfaction capacity of an individual undergoing skull base Surgeries using cautery vs scalpel . 
Scientific Title of Study   Olfactory outcomes of Cautery Vs Scalpel in Endoscopic Endonasal Skull Base Surgery- A Prospective Randomised Controlled Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ananya Srivastava 
Designation  PG student  
Affiliation  All India Institute of Medical Sciences 
Address  All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur-342005 Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9672423734  
Fax    
Email  ananyasrivastava1008@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaskaran Singh Gosal 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur-342005 Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  6283475891  
Fax    
Email  jhsgosal_87@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ananya Srivastava 
Designation  PG student 
Affiliation  All India Institute of Medical Sciences 
Address  All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur-342005 Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9672423734  
Fax    
Email  ananyasrivastava1008@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur-342005 Rajasthan,India 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  Basni Phase 2, MIA, Jodhpur 342005, Rajasthan 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ananya Srivastava  All India Institute of Medical Sciences, Jodhpur  Department of Neurosurgery,AIIMS, Basni Industrial Area Phase-2 Jodhpur-342005 Rajasthan
Jodhpur
RAJASTHAN 
9672423734

ananyasrivastava1008@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D3A8||Other benign neuroendocrine tumors,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cautery  During endoscopic endonasal skull base surgery,cautery will be used to elevate the nasoseptal flap. 
Intervention  Scalpel  During endoscopic endonasal skull base surgery,scalpel will be used to elevate the nasoseptal flap. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients undergoing endoscopic endonasal skull base surgeries that require the raising of a nasoseptal flap. 
 
ExclusionCriteria 
Details  1)Patients with preoperative anosmia due to any cause.
2) Patients with a previous history of sino-nasal, pituitary, or skull base surgery.
3) Patients with a medical history of neurodegenerative diseases (for example, Alzheimer’s disease or Parkinson’s disease), chronic rhinosinusitis 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Olfaction assessment using g I-smell tests, VAS scale  Preoperatively,Immediate Postoperatively,3-6 months following surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Other sinonasal outcome assessment using SNOT 22 questionnaire  Preoperatively,Immediate postoperatively,3-6 months following surgery  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   25/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief 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.

 
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