Background: Acute traumatic subdural hematoma represents a cause of permanent disability and mortality rate in the adult population. The aim of this study is to comparative outcomes of craniotomy and duraplasty versus craniotomy, duraplasty and lobectomy operations in patients with acute traumatic subdural hematoma.
Methods: patients with traumatic subdural hematoma are divided randomly who underwent surgical treatment, Craniotomy & Duraplasty (Group I), and Craniotomy, Duraplasty and Lobectomy (Group II). For all patients, Glasgow coma scale (GCS) before surgery and Glasgow Outcome Scale (GOS) after three months of surgery will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051313307N1
Registration date:2013-05-26, 1392/03/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-26, 1392/03/05
Registrant information
Name
Fariba Hushmandi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1846 5779
Email address
houshmandif881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2012-01-18, 1390/10/28
Expected recruitment end date
2013-08-11, 1392/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of Craniotomy and Duraplasty versus Craniotomy, lobectomy and duraplasty Operations in acute traumatic subdural hematoma
Public title
Craniotomy and Duraplasty versus Craniotomy, lobectomy and duraplasty Operations in sever head trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients higher than 18 years old, with traumatic subdural hematoma; patients with intracranial hypertension evidence, and patients with Glasgow outcome score (GCS) lower or equal to 8 before surgery.
Exclusion criteria: patients with peripheral or central neuropathy before surgery; patients with metabolic syndrome.
Age
From 18 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
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 Committee of Mashad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2011-02-11, 1389/11/22
Ethics committee reference number
631827
Health conditions studied
1
Description of health condition studied
traumatic subdural hematoma
ICD-10 code
S06.5
ICD-10 code description
Traumatic subdural haemorrhage
Primary outcomes
1
Description
Glasgow coma scale
Timepoint
pre and post operative evaluation
Method of measurement
Assessment of awareness by Glasgow coma scale questionnaire
Secondary outcomes
1
Description
Mortality rate and Glasgow Outcome Scale
Timepoint
3 months after surgery
Method of measurement
Assay the mortality and disability after operation by Glasgow Outcome Scale questionnaire
Intervention groups
1
Description
Group II: Craniotomy, Duraplasty and Lobectomy operations
Category
Treatment - Surgery
2
Description
Group I: Craniotomy and Duraplasty operations
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Kamyab Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Fariba Housmandi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Neurology Department, Ghaem Hospital, Ahmad Abad Ave.
City
Mashhad
Postal code
Phone
+98 51 1846 5779
Fax
Email
HoushmandiF881@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hosein Mashadinejad
Position
Associate professor of Neurosurgery
Other areas of specialty/work
Street address
Neurology Department, Ghaem Hospital, Ahmad Abad Ave.
City
Mashhad
Postal code
Phone
+98 51 1846 5779
Fax
Email
MashadinejadH@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Fariba Houshmandi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Neurology Department, Ghaem Hospital, Ahmad Abad Ave.
City
Mashhad
Postal code
Phone
+98 51 1846 5779
Fax
Email
HoushmandiF881@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)