| 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
|
|
|
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
|
|
|
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. |