A randomized controlled trial to compare the effect of endoscopic third ventriculostomy versus ventriculoperitoneal shunt insertion in infants less than one year of age with obstructive hydrocephalus
Objective:
comparison of the efficacy of ETV versus VP shunt in infants less than one year of age with obstructive hydrocephalus
Study design:
Randomized,two armed, unblind, parallel active control, single center, phase 2-3
Study population:
infants less than 1 year of age with obstructive hydrocephalus without any previous intervention or active infection
Sample size:
50 patients (25 in each arm)
Primary outcome:
Absence of abnormal increase in head circumference and absence of rICP signs
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020416483N1
Registration date:2016-04-18, 1395/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-18, 1395/01/30
Registrant information
Name
Amir Amininavai
Name of organization / entity
Tehran University of Medical Sciences, Shariati Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2384
Email address
amininavai.a@shariatihospital.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences Thesis Grant
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial to compare the effect of endoscopic third ventriculostomy versus ventriculoperitoneal shunt insertion in infants less than one year of age with obstructive hydrocephalus
Public title
Comparison of the results of ventriculoperitoneal shunt insertion and Endoscopic Third Ventriculostomy in obstractive hydrocephalus in infants less one year in children medical center hospital between 2013-2016
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All infants less than 1 year of age with obstructive hydrocephalus without any previous intervention for treatment of hydrocephalus
Exclusion criteria:
1. Presence of active infection
2. Parent of legal guardian discontent to sing the informed consent form
Age
To 1 year old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tehran University of Medical Sciences
Street address
Ghods Street, Central office of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-05-05, 1394/02/15
Ethics committee reference number
9011255002-140438
Health conditions studied
1
Description of health condition studied
Obstructive hydrocephalus
ICD-10 code
G91.1
ICD-10 code description
Primary outcomes
1
Description
Absence of َabnormal increase in head circumference
Timepoint
6 months
Method of measurement
Clinical examination and Imaging
2
Description
َbsence of raiseed intracranial pressure (rICP) signs
Timepoint
6 months
Method of measurement
Clinical examination and Imaging
Secondary outcomes
1
Description
CSF leakage
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination and Imaging
2
Description
Wound dehiscence
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination
3
Description
Bleeding
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination and Imaging
4
Description
Temporary ICP Rising
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination and Imaging
5
Description
Requiring ETV reoperation
Timepoint
Monthly
Method of measurement
Clinical examination and Imaging
6
Description
Requiring VP shunt
Timepoint
Monthly
Method of measurement
Clinical examination and Imaging
7
Description
Permanent ICP Rising
Timepoint
Monthly
Method of measurement
Clinical examination and Imaging
8
Description
EVD
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination and Imaging
9
Description
Shunt exposure
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination
10
Description
Obstruction of shunt proximal end
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination and Imaging
11
Description
Abdominal pseudocyst
Timepoint
Monthly
Method of measurement
Clinical examination and Imaging
12
Description
Infection
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination
13
Description
Meningitis
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination
14
Description
Subdural hematoma
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination and Imaging
15
Description
CSF collection
Timepoint
Daily for 7 days and then monthly
Method of measurement
Clinical examination
16
Description
Shunt dehiscence
Timepoint
Daily for 7 days and then monthly
Method of measurement
Imaging
Intervention groups
1
Description
Endoscopic third ventriculostomy
Category
Treatment - Surgery
2
Description
Ventriculoperitoneal Shunt
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center Hospital
Full name of responsible person
Dr Amir Amini Navai
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of medical sciences
Full name of responsible person
Dr Farideh Nejat
Street address
Ghods Street, Central office of Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of neurosurgery, Shariati Hospital, Tehran university of medical sciences, Tehran, Iran
Full name of responsible person
Dr Amir Amini Navai
Position
Resident of neurosurgery
Other areas of specialty/work
Street address
Kargar st., shariati hospital
City
Tehran
Postal code
Phone
+98 912 646 6585
Fax
Email
Dr.amini62@gmail
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of neurosurgery, Children Medical Center Hospital, Tehran University of Medical Sciences,
Full name of responsible person
Dr Farideh Nejat
Position
Professor of Neurosurgery
Other areas of specialty/work
Street address
Keshavarz Blvd, Gharib St.,Children Medical Center Hospital
City
Tehran
Postal code
Phone
+98 21 61470
Fax
Email
nejat@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of neurosurgery, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Dr Amir Amini Navai
Position
Resident of neurosurgery
Other areas of specialty/work
Street address
Kargar street, Shariati hospital
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)