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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   
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  
 
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  
 
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 
 
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 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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee- Human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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 
 
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 
 
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 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
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. 

 
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