Protocol summary

Study aim
Comparison of neuroendoscopic and non-endoscopic surgical techniques in treatment of septated chronic subdural hematoma
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. A simple blocking method will be used for randomization.
Settings and conduct
This study is performed in Besat Hospital of Hamadan, Hamadan Province. Sixty patients are randomly divided into two groups of endoscopic surgery and Barhol. Then, the mean duration of the operation, the recurrence rate 6 months after the clearance of mortality and postoperative morbidity, as well as the duration of hospitalization in patients will be evaluated.
Participants/Inclusion and exclusion criteria
Our study population is patients referred to Besat Educational and Medical Center in Hamedan in 1401. Inclusion criteria include: 1- Patients with chronic subdural hematoma 2- Patients with mixed density CT and 3- Satisfaction of patients or companions to enter the study Exclusion criteria include: 1- Patients with low level of consciousness (Glasgow coma score less than 9) 2- Acute subdural hematoma 3- Patients with involvement of several organs 4- Patients with a history of liver cirrhosis and coagulation disorders 5- Patients with a history Shant
Intervention groups
Intervention group 1: Patients who undergo endoscopic surgery. Control group: Patients who undergo surgery to perform surgery in the Brahol method (single or double Brahol).
Main outcome variables
Duration of surgery Mortality Morbidity Recurrence after 6 months Duration of hospitalization

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043934N14
Registration date: 2022-02-19, 1400/11/30
Registration timing: prospective

Last update: 2022-02-19, 1400/11/30
Update count: 0
Registration date
2022-02-19, 1400/11/30
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-20, 1400/12/29
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of neuroendoscopic and non-endoscopic surgical techniques in treatment of septated chronic subdural hematoma
Public title
Comparison of neuroendoscopic and non-endoscopic surgical techniques in treatment of septated chronic subdural hematoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic subdural hematoma Patients with CT with Mixed Density Patient consent or patient companion to enter the study
Exclusion criteria:
Patients with low level of consciousness (GCS less than 9) Acute subdural hematoma Patients with multi organ damage Patients with a history of liver cirrhosis Patients with a history of shunt
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study were randomly divided into two groups using simple blocking method: 1) endoscopic surgery intervention (A) or 2) control, naked (single or double bare) surgery (B). They will be. In this way, various quadrilateral blocks are first created using a sealed envelope (AABB, BBAA, ABAB, BABA, ABBA and BABA). One of these blocks is selected randomly and according to the order mentioned in the selected block, patients will be divided into one of two groups A or B. Then randomization is performed for other patients in the same way.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome Assessor: The study facilitator (hands in the field of neurosurgery) will assess the outcome during surgery, hospitalization and 6 months after discharge without knowing the patients in the surgery group. Patients participating in the study are not aware of being in the surgical group due to anesthesia and unfamiliarity with surgical methods. Analyzer: The data analyst is also unaware of the inclusion of individuals in the study and analyzes the data using defined codes.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Central Organization of Hamadan University of Medical Sciences.Shahid Fahmideh Street. Research Square. Hamadan. Hamadan Province
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2021-12-10, 1400/09/19
Ethics committee reference number
IR.HMSHA.REC.1400.717

Health conditions studied

1

Description of health condition studied
Subdural hematoma
ICD-10 code
S06.5
ICD-10 code description
Traumatic subdural hemorrhage

Primary outcomes

1

Description
Duration of surgery
Timepoint
During surgery in the operating room
Method of measurement
Using field observation and survey

2

Description
Recurrence rate of surgery
Timepoint
6 months after discharge
Method of measurement
By examining and performing the relevant tests

3

Description
mortality rate
Timepoint
After surgery
Method of measurement
Check mortality statistics

4

Description
Morbidity
Timepoint
After surgery
Method of measurement
Question from the patient

5

Description
Duration of hospitalization
Timepoint
After surgery
Method of measurement
Check the patient file

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients who undergo endoscopic surgery.
Category
Treatment - Surgery

2

Description
Control group: Patients who undergo surgery to perform surgery in the Brahol method (single or double Brahol).
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital, Hamedan
Full name of responsible person
Fahimeh Esmaeeli
Street address
Besat Hospital. Shahid Beheshti Blvd. Hamedan,
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Fahimeh Esmaeeli
Street address
استان همدان، همدان، میدان پژوهش، خیابان شهید فهمیده، ستاد دانشگاه علوم پزشکی همدان
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
No.56, Jorjani Ave, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
oabstdent@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Fahimeh Esmaeeli
Position
Member of the Faculty
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Central Organization of Hamadan University of Medical Sciences.Shahid Fahmideh Street. Research Square. Hamadan. Hamadan Province
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
Fahimeh_ee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Central Organization of Hamadan University of Medical Sciences.Shahid Fahmideh Street. Research Square. Hamadan. Hamadan Province
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
oabstudent@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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