The aim of this study is to compare the possible advantages and disadvantages of siphon washing method with traditional method in chronic subdural hemorrhage(CSDH) .
Design
Clinical trial with 2 groups, with parallel groups (, double-blind, randomized, phase 0 on 60 patients. Using random numbers
Settings and conduct
The operating room of Bahonar Hospital in Kerman will have two surgical procedures. Due to the patient being unconscious, one side will be blind . The type of surgery is performed by a neurosurgeon, and therefore the physician evaluating the consequences of the surgery and analyzing the data will be unaware of the treatment protocol.
Participants/Inclusion and exclusion criteria
Patients with CSDH confirmed by CT scan for more than 72hr with GCS decline, neurological deficit and gait disorder should be referred to Bahonar Hospital
Intervention groups
Siphon group : first the burr hole is placed and then after opening the Dura by placing the catheter in the part of the hematoma that is the largest and lower volume, continuously by pouring saline into the burr hole from the catheter. The distal head is located below the patient's head. The chronic hematoma is continuously drained until clear fluid comes out. Finally, after ventilating and fixing the catheter, the skin is closed and a drain is placed at the level of the head.
burr hole method: In each patient a 16 mm diameter burr hole is created in the convexity of the skull under general anesthesia. The dura and outer membrane are incised and the hematoma cavity is flushed with warm physiological saline until clear fluid is removed and the space is filled with isotonic saline, then the drain is placed in the empty space.
Main outcome variables
Recurrence CSDH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211130053232N1
Registration date:2022-01-09, 1400/10/19
Registration timing:prospective
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Mohammad Agha Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 5011
Email address
drmohammadi24@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of treatment of chronic subdural hemorrhage by siphon method in patients referred to Bahonar Hospital in Kerman
Public title
Evaluation of treatment of chronic cerebral hemorrhage by siphon method in patients referred to Bahonar Hospital in Kerman
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic subdural hemorrhage for more than 72 hours
Decrease GCS
Neurological deficits
Gait disorder
Exclusion criteria:
Patient dissatisfaction in participating in the study
Taking anticoagulants
History of craniocerebral surgery
Rebleeding after burr hole craniostomy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, sampling is first available and then eligible patients will be randomly assigned to two groups. For this purpose, first a random sequence will be created from the table of random numbers. Then the extracted even numbers will be assigned to the siphon group and the odd numbers will be assigned to the burr hole group. This process will continue to reach the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is two-way blind so that the participant and the physician evaluating the outcome and the data analyzer are unaware of the type of surgical procedure And only the surgeon will know the type of operation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman,The beginning of Haft Bagh Alavi Road, Kerman University of Medical Sciences Campus
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-11-23, 1400/09/02
Ethics committee reference number
IR.KMU.REC.1400.496
Health conditions studied
1
Description of health condition studied
Subdural hemorrhage
ICD-10 code
I62.03
ICD-10 code description
Nontraumatic chronic subdural hemorrhage
Primary outcomes
1
Description
Treatment of chronic subdural hemorrhage by siphon method
Timepoint
12 months
Method of measurement
Checklist and examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Siphon craniostomy, first the burr hole is placed and then after opening the Dura by placing the catheter in the part of the hematoma that is the largest and lower volume, continuously by pouring saline into the burr hole from the catheter. The distal head is located below the patient's head. The chronic hematoma is continuously drained until clear fluid comes out. Finally, after ventilating and fixing the catheter, the skin is closed and a drain is placed at the level of the head. burr hole method: In each patient a 16 mm diameter burr hole is created in the convexity of the skull under general anesthesia. The dura and outer membrane are incised and the hematoma cavity is flushed with warm physiological saline until clear fluid is removed and the space is filled with isotonic saline, then the drain is placed in the empty space.
Category
Treatment - Surgery
2
Description
Control group: burr hole craniostomy, In each patient a burr hole is created in the skull. The dura and outer membrane are incised and the hematoma cavity is washed with physiological saline until clear fluid is removed, and the space is filled with isotonic saline, then the drain is placed in the empty space.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital in Kerman
Full name of responsible person
Mohammad Agha Mohammadi
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
drmohammadi24@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Somayeh crossroad
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
kmu_research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Agha Mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
drmohammadi24@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamed Reyhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
reyhani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Agha Mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
drmohammadi24@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, some of the information, including side effects, the consequences of the surgical procedure after unrecognizing individuals, will be shared with health care professionals.
When the data will become available and for how long
2 months after data analysis
To whom data/document is available
Health researchers
Under which criteria data/document could be used
In order to use the results and during the written request
From where data/document is obtainable
Mohammad Agha Mohammadi- Email
What processes are involved for a request to access data/document
The purpose of accessing data - requesting e-mail- Information will be sent a week after the request