| CTRI Number |
CTRI/2024/10/075839 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Life After Surgery for Lateral Skull Base Tumors: Patient Outcomes and Quality of Life |
|
Scientific Title of Study
|
Outcomes of patients surgically treated for lateral skull base tumours with special reference to quality of life |
| 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 Simran Chaudhary |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Delhi |
| Address |
A626, 6th floor, Department of ENT, NEW RAK Building, AIIMS Delhi, Ansari Nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8076097261 |
| Fax |
|
| Email |
simmychaudhary02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Sikka |
| Designation |
Professor |
| Affiliation |
AIIMS Delhi |
| Address |
A613, 6th floor, Department of ENT, NEW RAK Building, AIIMS Delhi, Ansari Nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9810423088 |
| Fax |
|
| Email |
kapil_sikka@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kapil Sikka |
| Designation |
Professor |
| Affiliation |
AIIMS Delhi |
| Address |
A613, 6th floor, Department of ENT, NEW RAK Building, AIIMS Delhi, Ansari Nagar, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9810423088 |
| Fax |
|
| Email |
kapil_sikka@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, India 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS Delhi |
| Address |
AIIMS Delhi, Ansari Nagar, New Delhi 110029 |
| 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 Simran Chaudhary |
AIIMS DELHI |
A626, 6th floor, Department of ENT, NEW RAK OPD, AIIMS Delhi, Ansari Nagar, New Delhi 110029
New Delhi
DELHI |
8076097261
simmychaudhary02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for Post Graduate Research |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with lateral skull base tumors who have been surgically treated over the past 10 years (Retrospective cohort)
2. Patients with lateral skull base tumors who will be surgically operated till June 2025 (prospective cohort)
3. Patients and attendants consenting for inclusion in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with neurological deficits unrelated to lateral skull base tumors.
2. Patients and attendants not giving consent for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcomes in terms of residual disease
Quality of life
Speech and swallowing outcomes
Cranial nerve function
|
Prospective - at the time of surgery, 1 week and every 6 months.
Retrospective - at the time of recruitment and every 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Retrospective - To compare preoperative & postoperative quality of life in patients |
At the time of recruitment & every 6 months. |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/11/2024 |
| 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="2"
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
|
• After approval from ethics committee, the study will proceed. • Patients fitting into the inclusion criteria and exclusion criteria will be recruited after I/W consent. • A pre surgery evaluation of cranial nerve palsies, facial nerve status, quality of life, speech and swallowing will be done. • Patient will be followed up 1 week immediately after surgery and then every 6 months. They will be assessed in the same manner as preoperatively. • Patients retrospectively recruited will be contacted telephonically and followed up subsequently every 6 months. |