to compare to method of surgery (one bur hole vs two bur hole) in chronic subdural hematoma treatment
Design
as frequent retrospective studies in this matter, no difference between these two methods has been told, so we decide to design a prospective interventional study. randomization will be done by the 4, 6, and 8 block methods. then concealment will be done so the person who does this randomization, does not become aware of group interventions.
Settings and conduct
patients who come to Shariati hospital and meet inclusion/exclusion criteria will be randomized in one of two methods of surgery after receiving informed consent. as it is not possible to blind the caregivers, people who collect and analyze data will be blind to intervention groups.
Participants/Inclusion and exclusion criteria
men and women patients more than 18 years old that cSDH diagnosed with a brain CT scan and has a 5 mm or more midline shift and/or obvious pressure effect on the underlying cortex and/or clinical symptoms justified by hematoma will be included.
patients with less than 18 years of age, pregnancy, breastfeeding, acute sepsis, history of brain shunt due to hydrocephaly, active psychological disease, patients who can not participate in follow-up, and uncorrectable coagulopathy before surgery will be excluded.
Intervention groups
patients will randomly be put in one or two bur hole intervention groups. finally, recurrence will be evaluated in these two groups.
Main outcome variables
recurrence is the main outcome will be evaluate after follow up period.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221016056192N1
Registration date:2022-10-27, 1401/08/05
Registration timing:prospective
Last update:2022-10-27, 1401/08/05
Update count:0
Registration date
2022-10-27, 1401/08/05
Registrant information
Name
faramarz roohollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 6684
Email address
faramarzroohollahi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of one burr hole vs two burr holes surgery in recurrence of chronic subdural hematoma
Public title
A comparison of one burr hole vs two burr holes surgery in recurrence of chronic subdural hematoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
male or female patients more than 18 years old
a minimum of 5 mm shift in brain CT scan
obvious pressure effect on cortex underlying hematoma
clinical symptoms justifiable to hematoma
Exclusion criteria:
pregnancy period
breastfeeding period
Sepsis
active psychological disorders
second surgery in first 48 hours because of technical issues
patients who will not attend for follow up
history of CSF diversion surgery
empyema
Age
From 18 years old
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
Random lists of patient allocation will be based on random blocks of 4, 6 and 8. The allocation would be concealed by the randomizer and the person in charge of randomization wouldn't be aware of the treatment they groups would receive. We will generate these random blocks using www.sealedenvelope.com. (Sealed Envelope Ltd. 2022. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, we want to investigate two different surgical procedures and since the patients and their relatives will receive a complete description of possible interventions in this study, blinding the patients wouldn't be possible. The patients will have the same number of scalp incisions and scars as the number of burr holes used and that's why they can't be blinded. This is also true for outcome assessors as they can also become aware of allocated groups.
Those who'll be performing the procedure would become aware of it and they can't be blinded too.
So, in this study only those who analyze and manage the data can be and will be blinded to the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shariati hospital ethics committe,tehran university of medical scince
Street address
kargar shomali sreet
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2022-07-04, 1401/04/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.279
Health conditions studied
1
Description of health condition studied
chronic subdural hematoma in brain
ICD-10 code
I62.03
ICD-10 code description
Nontraumatic chronic subdural hemorrhage
Primary outcomes
1
Description
recurrence outcome explained as incidence new deficits or exacerbation of clinical condition of patient any time after 48 hours to 6 months of surgery which will confirm with new brain CT scan revealing new hematoma.
Timepoint
1 month and 6 month since surgery
Method of measurement
patients must attend to clinic for check up after 1 month and 6 month of surgery.. if there was neurological deficit CT will be done and recurrence will be assesd.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients who will undergo one bur hole method surgery. patients will go under general anesthesia in both groups. in the supine position, superior to the superior temporal line, an incision will make. after preparing the skull bone, one bur hole will prepare by the perforator. after coagulation and opening of the dura and exiting of SDH fluid, we will irrigate into the hole with warm 37-degree sterile normal saline serum with a syringe until the exiting fluid is clear. a subperiosteal drain will be fixed. the small incision will be sutured by a 2-0 nylon thread. the drain will be equal to the level of the patient's head.
Category
Treatment - Surgery
2
Description
Control group: patients who will undergone two bur hole method surgery. all the steps will be the same as intervention group but instead of one incision, two incision will made superior to superior temporal line and one bur hole in each will be prepared. irrigation will be done from both holes. in the end, similar to other group, one drain will be fix in anterior incision.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Faramarz Roohollahi
Street address
Kargar Shomali Ave, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 6488
Email
faramarzroohollahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohi
Street address
Kargar Shomali Street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 6488
Email
faramarzroohollahi@yahoo.com
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
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
Tehran University of Medical Sciences
Full name of responsible person
Faramarz Roohollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Shariati hospital, Kargar Shomali
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 6684
Email
faramarzroohollahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Faramarz Roohollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Shariati hospital, Kargar Shomali
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
00892188006684
Email
faramarzroohollahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Faramarz Roohollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Kargar Shomali Ave, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 6684
Email
faramarzroohollahi@yahoo.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
Data will contain age, sex, surgery method, time of recurs, blood loss, primary symptoms and brain CT features.
whole data will be shared after identified process was done.
When the data will become available and for how long
data files will be available one month after publication.
To whom data/document is available
Data will be available for people working in academic institutes .
Under which criteria data/document could be used
data will be shared for whom doing studies about outcomes of cSDH surgery to improve or describe methods of surgery.
From where data/document is obtainable
all people working in academic institutes can contact E-mail address below : faramarzroohollahi@yahoo.com
What processes are involved for a request to access data/document
after receiving E-mail for accessing file of data, we will respond in less than 48 hours.