The effect of endoscopic third ventricleostomy in the treatment and prevention of obstructive hydrocephalus in patients with posterior fossa tumors of the brain in patients referred to the hospital
The effect of endoscopic third ventricleostomy in the treatment and prevention of obstructive hydrocephalus in patients with posterior fossa tumors of the brain in patients referred to the hospital
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. The sample size for each study group is 20.
Settings and conduct
In this research, all patients referred to the Hazrat Rasoul Akram Hospital, who have posterior fossa tumors of the brain will be enrolled. Patients will be randomly divided into two groups based on 4 blocks. A total of 40 patients will be examined. Data analyzers will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Rasoul Akram Hospital, who have posterior fossa tumors of the brain will be enrolled. All patients with tumorous lesions of the posterior fossa of the brain with obstructive hydrocephalus. Exclusion criteria: Patients who had a recurrence of the tumor.
Intervention groups
In the intervention group, For patients with posterior fossa tumors of the brain the endoscopic third ventricleostomy will be performed. In the control group: For patients with posterior fossa tumors of the brain, a brain shunt will be placed.
Main outcome variables
Intra brain pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171124037606N3
Registration date:2019-03-10, 1397/12/19
Registration timing:prospective
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Alireza Tabibkhooei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2228
Email address
tabibkhooei.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endoscopic third ventricleostomy in the treatment and prevention of obstructive hydrocephalus in patients with posterior fossa tumors of the brain in patients referred to the hospital
Public title
Endoscopic third ventricleostomy in the treatment and prevention of hydrocephalus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with tumorous lesions of the posterior fossa of the brain with obstructive hydrocephalus
Exclusion criteria:
Patients who had a recurrence of the tumor
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 4 person. In each block, 2 individuals will be in intervention group and 2 will be in control group. A total of 10 blocks will be considered for sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data will be analyzed by person who is blind to study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-11-13, 1396/08/22
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9411255004
Health conditions studied
1
Description of health condition studied
Obstructive hydrocephalus
ICD-10 code
G91.1
ICD-10 code description
Obstructive hydrocephalus
Primary outcomes
1
Description
Intra brain pressure
Timepoint
One week continuously (24 hour)
Method of measurement
Using ICP monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For patients with posterior fossa tumors of the brain, the endoscopic third ventricleostomy will be performed.
Category
Treatment - Surgery
2
Description
Control group: For patients with posterior fossa tumors of the brain, a brain shunt will be placed.