CTRI Number	CTRI/2010/091/000525 [Registered on: 25/11/2010]
Last Modified On:	16/02/2022
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study Modification(s)	Surgical/Anesthesia
Study Design	Randomized, Parallel Group Trial
Public Title of Study Modification(s)	Effectiveness of early surgery over usual waiting list surgery (medical therapy) in Childhood Drug Refractory Epilepsy-(CDRE)
Scientific Title of Study Modification(s)	A Randomized controlled trial of early versus usual waitng list surgery in childhood intractable epilepsy
Secondary IDs if Any Modification(s)	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Manjari Tripathi  Address  Room No-705, 7th Floor,C.N.C. AIIMS New Delhi DELHI 110029 India  Phone  011-26594494   Fax     Email  manjari.tripathi@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Manjari Tripathi   Address  Room No-705,7th Floor, CNC,AIIMS New Delhi DELHI 110029 India  Phone  011-26594494   Fax     Email  manjari.tripathi@gmail.com
Details Contact Person Public Query Modification(s)	Name  Rekha Dwivedi  Address  Room No-705,Dept of Neurology 7th Floor,CNC,AIIMS New Delhi DELHI 110029 India  Phone  011-26594494   Fax     Email  rekha.dwivedi2006@gmail.com
Source of Monetary or Material Support Modification(s)	All India Institute of Medical Sciences (AIIMS)
Primary Sponsor Modification(s)	Name  All India Institute of Medical Sciences AIIMS  Address  Ansari Nagar New Delhi INDIA PIN CODE 110029  Type of Sponsor  Research institution and hospital
Details of Secondary Sponsor Modification(s)	Name  Address  NIL
Countries of Recruitment Modification(s)	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  DrManjari Tripathi  AIIMS  Ansari Nagar,AIIMS-110029 New Delhi   011-26594494 manjari.tripathi@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 4   Name of Committee  Approval Status  AIIMS  Approved  All India Institute of Medical Sciences   Approved  Data Safety Management Board  Approved  DSMB  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Childhood Intractable Epilepsy  Patients  Epilepsy, unspecified
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  Early Epilepsy surgery  After randomization subject will be enrolled within one month  Comparator Agent  usual waiting list epilepsy surgery or Medical therapy  Subject will be enrolled as per the usual waiting list of surgery (medical therapy till dated surgery) that may be one year or so.
Inclusion Criteria Modification(s)	Age From  1.00 Month(s) Age To  18.00 Year(s) Gender  Both  Details  1) All children with DRE patients: age ≤18 years. 2) Patients having DRE, defined as failure of adequate trials of two tolerated and appropriately chosen and used anti-epileptic drug schedules for years to achieve sustained seizure freedom. 3)All patients should have been cleared by the Unit III-epilepsy surgery-case conferences team. 4)All parents of patients or Legally Acceptable Representative (LAR)should be able to give Consent for participation.
ExclusionCriteria	Details  1) All patients who have underlying metabolic abnormality, cardiac abnormality, renal failure and respiratory disease. 2) Those patients having Status Epilepticus requiring early or immediate surgery(as these are not put in wait list).
Method of Generating Random Sequence Modification(s)	Computer generated randomization
Method of Concealment Modification(s)	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking Modification(s)	Outcome Assessor Blinded
Primary Outcome Modification(s)	Outcome  TimePoints  The primary outcome will be to assess the seizure freedom between the two groups by International League Against Epilepsy (ILAE) Scale or Engels Scale at 12 months  Baseline, Six months and one year follow-up.
Secondary Outcome Modification(s)	Outcome  TimePoints  To assess the differences in the occurrence of seizures over a period of 12 months, and seizure-severity, cognition, behavior and quality of life by the following measures: the Hague seizure Severity (HASS) scale, Binet Kamat Test (BKT ) and Vineland Social Maturity Scale (VSMS), Child Behavior Check List (CBCL) ,Pediatrics Quality of Life (PedsQL), respectively.  Baseline,Six months and One year follow-up
Target Sample Size Modification(s)	Total Sample Size="116" Sample Size from India="116"
Phase of Trial Modification(s)	Phase 3
Date of First Enrollment (India) Modification(s)	01/11/2010
Date of First Enrollment (Global)	01/11/2010
Estimated Duration of Trial Modification(s)	Years="5" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	under revision
Brief Summary Modification(s)	This study is a randomized controlled trial to assess the efficacy of the early epilepsy surgery over usual-dated  epilepsy surgery (with continued medical therapy) in surgically remediable childhood drug refractory epilepsy. It is being conducted in All India Institute of medical Sciences (AIIMS), New Delhi. The primary objective of this study is to assess the outcome of seizures in the epilepsy surgery (Intervention group) versus the usual waiting list surgery with medical therapy (non-intervention group) at 12 months.The secondary objective of the study is  to evaluate seizure severity, cognition, behavior and quality of life through clinical and neuro-psychological assessment  by  the Hague Seizure Severity (HASS) scale, Binet Kamat Test (BKT),Vineland Social Maturity Scale (VSMS), Child Behavior Check List (CBCL) and Pediatrics Quality of Life (PedsQL), respectively between the two groups .