| CTRI Number |
CTRI/2026/03/106189 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Does Pre-Surgery Physical Weakness Affect Outcomes After Brain Tumor Surgery? |
|
Scientific Title of Study
|
Association of frailty with clinical outcomes in patients undergoing brain tumor surgery: a prospective observational 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 Chayanika Kutum |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Anaesthesiology, First floor IPD building, AIIMS Nagpur
Nagpur MAHARASHTRA 441108 India |
| Phone |
9004598302 |
| Fax |
|
| Email |
Chayanikakutum@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chayanika Kutum |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Anaesthesiology, First floor IPD building, AIIMS Nagpur
MAHARASHTRA 441108 India |
| Phone |
9004598302 |
| Fax |
|
| Email |
Chayanikakutum@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Chayanika Kutum |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Anaesthesiology, First floor IPD building, AIIMS Nagpur
MAHARASHTRA 441108 India |
| Phone |
9004598302 |
| Fax |
|
| Email |
Chayanikakutum@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Nagpur |
| Address |
Department of Anaesthesiology, First floor IPD building, AIIMS Nagpur, MIHAN, Nagpur-441108, Nagpur, Maharashtra |
| Type of Sponsor |
Government medical college |
|
|
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 Chayanika Kutum |
AIIMS Nagpur |
Department of Anaesthesiology, First floor IPD building, AIIMS Nagpur Nagpur MAHARASHTRA |
9004598302
Chayanikakutum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults more than or equal to 18 years of age
Diagnosed with a primary or metastatic brain tumor
Planned for craniotomy and resection
Able to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Emergency surgery where frailty assessment is not feasible
Severe cognitive impairment preventing frailty assessment
Refusal to participate
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Occurrence of anypostoperative complication (neurological or medical).
Neurological complications: infarct, hemorrhage, cranial nerve palsy, hydrocephalus, cerebral edema, meningitis, seizures, CSF leak.
Medical complications: pneumonia, DVT, PE, MI, sepsis, AKI, UTI.
Grading of the above complications as per the Clavien Dindo classification. |
At 30 days after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay & Discharge disposition (home vs. rehabilitation/nursing facility) |
Measured at discharge from hospital. |
| Postoperative functional status |
At discharge, 30 days & 90 days |
| All cause mortality |
At 90 days |
|
|
Target Sample Size
|
Total Sample Size="415" Sample Size from India="415"
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)
|
01/04/2026 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Brain tumors account for a significant disease burden, and surgical removal remains the primary treatment. However, postoperative complications are common and can affect recovery and survival. While tumor-related factors are traditionally used to predict outcomes, patient-related factors such as frailty — a condition reflecting reduced physiological reserve — may also play an important role. Frailty has been associated with increased postoperative complications, prolonged hospital stay, mortality, and poorer functional recovery in various surgical populations. In neurosurgical oncology, most available evidence is retrospective, and prospective data are limited. This prospective single-centre cohort study aims to evaluate the association between preoperative frailty (assessed using the Clinical Frailty Scale [CFS] and 5-item Modified Frailty Index [mFI-5]) and short-term outcomes in adults undergoing elective brain tumor surgery. The primary objective is to determine the relationship between frailty and 30-day postoperative neurological and medical complications. Secondary objectives include assessing hospital stay duration, functional recovery (Karnofsky Performance Status), 90-day mortality, and discharge disposition, as well as evaluating the predictive accuracy of frailty tools. A total of 415 adult patients undergoing elective craniotomy for primary or metastatic brain tumors will be enrolled. Frailty will be assessed preoperatively using standardized tools. Postoperative outcomes will be recorded by blinded investigators. Multivariable analysis will be performed to adjust for confounding factors. This study aims to validate frailty assessment as a practical tool for perioperative risk stratification and to support individualized care in brain tumor surgery. |