| CTRI Number |
CTRI/2022/09/045817 [Registered on: 23/09/2022] Trial Registered Prospectively |
| Last Modified On: |
04/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using SKALE and other preoperative scores to know the post operative outcome in intracranial tumor surgery |
|
Scientific Title of Study
|
Utility of preoperative risk stratification using SKALE and Charlson co-morbidity scores to predict postoperative outcome in patients with intracranial tumours |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meghana S |
| Designation |
Junior Resident |
| Affiliation |
Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai |
| Address |
Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra 400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
8073291992 |
| Fax |
|
| Email |
megshegde@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hemangi Karnik |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai |
| Address |
Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra 400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9324501900 |
| Fax |
|
| Email |
dr_hemangi@hotmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Hemangi Karnik |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai |
| Address |
Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra 400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9324501900 |
| Fax |
|
| Email |
dr_hemangi@hotmail.com |
|
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Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra 400022 |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal Medical College |
| Address |
Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra 400022 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meghana S |
Lokmanya Tilak Municipal Medical College and General Hospital |
Neurosurgery operation theatre, fourth floor, OPD building, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, Maharashtra 400022 Mumbai MAHARASHTRA |
8073291992
megshegde@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee- Human research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D331||Benign neoplasm of brain, infratentorial, (2) ICD-10 Condition: D330||Benign neoplasm of brain, supratentorial, (3) ICD-10 Condition: D332||Benign neoplasm of brain, unspecified, (4) ICD-10 Condition: D320||Benign neoplasm of cerebral meninges, (5) ICD-10 Condition: D333||Benign neoplasm of cranial nerves, (6) ICD-10 Condition: C724||Malignant neoplasm of acoustic nerve, (7) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (8) ICD-10 Condition: C716||Malignant neoplasm of cerebellum, (9) ICD-10 Condition: C700||Malignant neoplasm of cerebral meninges, (10) ICD-10 Condition: C715||Malignant neoplasm of cerebral ventricle, (11) ICD-10 Condition: C710||Malignant neoplasm of cerebrum, except lobes and ventricles, (12) ICD-10 Condition: C711||Malignant neoplasm of frontal lobe, (13) ICD-10 Condition: C714||Malignant neoplasm of occipital lobe, (14) ICD-10 Condition: C713||Malignant neoplasm of parietal lobe, (15) ICD-10 Condition: C712||Malignant neoplasm of temporal lobe, |
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients posted for elective surgeries for intracranial tumour excision |
|
| ExclusionCriteria |
| Details |
patients/next of kin not willing to give consent for study
patients planned for stereotactic biopsy
patients planned for transnasal excision without craniotomy |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1. To note feasibility of application of preoperative risk stratification scores- SKALE (sex, Karnofsky performance status (KPS), ASA physical status (ASA), location of tumour, edema), and Charlson co-morbidity index in patients with intracranial tumours.
2. To correlate each of these scores with postoperative complications and adverse outcome in patients with intracranial tumours.
|
before surgery, post operative day one of surgery and at discharge |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To correlate ASA, GCS and KPS score individually with postoperative outcome in patients with intracranial tumours.
|
pre operative and post operative period |
|
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Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
30/09/2022 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
not yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
After IEC-HR permission, all patients admitted in
neurosurgical wards for neurosurgical procedure, satisfying all inclusion and
exclusion criteria will be considered for inclusion into the study. All patients or their near relations will
be explained about the study and a written valid informed consent for their
willingness to participate in the study will be taken. All demographic data of
the patients will be noted from the patient’s history and case sheets. Later, a
detailed preoperative assessment will be done on the patient and following
scores will be applied.
·
American society of
anaesthesiologists physical status( ASA-PS)
·
Glasgow coma scale (GCS)
·
Karnofsky performance
score (KPS)
·
SKALE- Sex, Karnofsky
performance score, American society of anaesthesiologist class, location of
tumour and peritumoural edema grading system
· Charlson
Comorbidity Index
Each
individual feature of a particular scoring system is understood and thus marked
whichever describes the patient’s condition the best. Total score will be
calculated for each scoring system.
Following
intraoperative variables will be noted.
· Duration of surgery
· Position of surgery
· Intraoperative blood loss
· Intraoperative adverse events if any.
o
Hypotension
> 25% baseline
o
Arrhythmias
o
Hypoxia
(spO2 <90%)
o
Air
embolism
o
Any
other event affecting outcome
Need for
ventilator support with duration will be noted. Post surgery, the patient will
be reassessed on post operative day 1(POD1). All patients will be followed up
till discharge for noting their postoperative course in ward, any complications
that may develop and if any resurgery is needed. Karnofsky performance score
will be assessed again prior to discharge and will be compared with the
preoperative status.
Different
scoring systems will be evaluated for their preoperative scores and their
predictability of post operative outcome.
|