FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/089352 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 23/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   ERAS Protocol on outcomes in elective Glioma surgery; A Randomized control Trial 
Scientific Title of Study   Assessing the impact of Enhanced Recovery After Surgery Protocol (ERAS) on outcomes in elective Glioma surgery; A Randomized control Trial 
Trial Acronym  ERAS in Glioma Surgery 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Praneeth prem kumar 
Designation  Neurosurgery 
Affiliation  SVIMS 
Address  26-1-398 society colony jammalamadugu YSR kadapa 516434

Chittoor
ANDHRA PRADESH
517501
India 
Phone  08801117754  
Fax    
Email  drpraneethpremkumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V V Ramesh chandra 
Designation  Neurosurgery 
Affiliation  SVIMS 
Address  Department of neurosurgery SVIMS Tirupati

Chittoor
ANDHRA PRADESH
517501
India 
Phone  08801117754  
Fax    
Email  drpraneethpremkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G Praneeth prem kumar 
Designation  Neurosurgery 
Affiliation  SVIMS 
Address  26-1-398 society colony jammalamadugu YSR kadapa 516434


ANDHRA PRADESH
517501
India 
Phone  08801117754  
Fax    
Email  drpraneethpremkumar@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sri venkateswara institute of medical sciences 
Address  Department of neurosurgery SVIMS Alipiri Tirupati. Andhra Pradesh India 517507 
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 Praneeth prem kumar  Sri Venkateswara Institute of medical sciences  Department of neurosurgery 2nd floor Padmavathi block SVIMS Tirupati Andhra Pradesh 517507
Chittoor
ANDHRA PRADESH 		 8801117754

drpraneethpremkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Venkateswara institute of medical sciences institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Craniotomy & Excision  Less time of nbm 2 hours of clear fluids and and glucose drink early mobilisation of patient in post op early drain removal  
Intervention  Craniotomy and excsion  overnight NBM of the patient normal time for mobilisation and drain removal after 3 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 18 years and above.
Patients must be adults capable of giving informed consent.
Radiologically suspected supratentorial glioma.
Diagnosis should be based on MRI brain with contrast suggestive of glioma (low-grade or high-grade, as per study protocol).
Karnofsky Performance Status (KPS) 70.
Patients should be functionally independent and fit for surgery.
Operable tumor as determined by neurosurgical evaluation.
Tumor must be deemed safely accessible for resection based on preoperative imaging.
No prior cranial surgery or radiotherapy for the same lesion.
To ensure treatment-naive status and reduce confounding variables.
Informed written consent obtained.
Patients must be willing to participate and comply with the protocol including randomization and follow-up.
No evidence of multifocal disease or diffuse leptomeningeal spread.
For focused surgical intervention.
Ability to undergo MRI with or without contrast.
Required for surgical planning and postoperative assessment. 
 
ExclusionCriteria 
Details  Age below 18 years.
Pediatric patients are excluded due to differing tumor biology and management protocols.
Karnofsky Performance Status (KPS) less than 70.
Patients with poor functional status may not tolerate surgery or postoperative rehabilitation well.
Evidence of multifocal glioma or diffuse leptomeningeal spread.
These cases are typically not suitable for focal surgical resection.
Previous surgery or radiotherapy for the current brain lesion.
Prior treatment may alter tumor characteristics and surgical planes, affecting study outcomes.
Deep seated tumors involving eloquent cortex or midline structures that preclude safe resection.
To avoid undue surgical risk and standardize resectability.
Contraindications to MRI
MRI is essential for both preoperative planning and postoperative follow-up.
Significant comorbidities or systemic illness
Which may increase perioperative risk or interfere with followup.
Pregnancy or breastfeeding.
Due to potential risks from anesthesia imaging and surgical intervention.
Known allergy or contraindication to contrast agents or surgical adjuncts used in the study
Inability or unwillingness to provide informed consent or comply with follow-up.
Including cognitive impairment or language barriers that impede understanding of the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Length of stay after operation with in 5 days
2. 30 days re admission rate with in 4 weeks
 		 with in 6 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   25/06/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drpraneethpremkumar@gmail.com].

  6. For how long will this data be available start date provided 15-02-2025 and end date provided 03-09-2040?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   We are inviting eligible patients diagnosed with supratentorial gliomas to participate in a randomized controlled trial evaluating the outcomes of advanced surgical techniques in glioma resection. Participants will be randomly assigned to one of the treatment arms involving either standard microsurgical resection or surgery guided by advanced adjuncts such as intraoperative navigation, neurophysiological monitoring, or fluorescence imaging. All procedures will be performed by experienced neurosurgeons adhering to current best practices. Participation is voluntary, and comprehensive information about the study, including potential risks and benefits, will be provided before obtaining informed consent. The aim of the trial is to improve surgical outcomes, reduce neurological deficits, and optimize overall survival and quality of life in glioma patients 
Close