The aim of this study was to comparison of surgical clipping and international coiling in the progressive anterior circulation of brain aneurysms.
Design
Randomized, community-based, and pragmatic clinical trial with parallel, double-blind, and randomized groups.
Settings and conduct
In this study, 120 patients who have been diagnosed with cerebral arterial aneurysm (GCS greater than or equal to 9) were investigated at Imam Reza Hospital and Shams Tabriz Hospital for the purpose of clipping surgery and coiling treatment interventions. Assignment of patients to intervention groups was done randomly using paired and randomized random numbers and patient records. At the end of the study, patients followed for post-operative mortality rate, post-surgical complications and re-bleeding and wall aneurysm improvement.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Glasgow coma scale (GCS) equal to and greater than 9, non-giant aneurysms of less than 10 mm in size, anterior cerebellar aneurysms.
Exclusion criteria include: GCS less than 8, Giant's aneurysms greater than 10 mm, desiccant aneurysms.
Intervention groups
Intervention group 1 (Clipping): that the clips used to attach the neck of the brain's aneurysms.
Intervention group 2 (Coiling): Using composite springs to fill the aneurysm and remove it from the main circulation system.
Main outcome variables
Post-operative mortality rate and complications, re-bleeding frequency and aneurysm wall improvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N4
Registration date:2018-11-03, 1397/08/12
Registration timing:registered_while_recruiting
Last update:2018-11-03, 1397/08/12
Update count:0
Registration date
2018-11-03, 1397/08/12
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-11, 1397/05/20
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of surgical clipping and interventional coiling in the progressive anterior circulation aneurysms of brain.
Public title
Comparison of surgical methods in the treatment of cerebral arteries aneurysms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Glasgow coma scale (GCS) equal or greater than 9
Non-giant aneurysms of less than 10 mm in size
Anterior circular aneurysms of the brain
Exclusion criteria:
Glasgow coma scale (GCS) less than 8
Giant's aneurysms larger than 10 mm
Desiccant aneurysms
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
First, patients will be listed by file number. Then, by using the rand command in Microsoft EXCEL 2007 software, for each patients, a code between 1 and 120 will be assigned. To divide the patients into the first and second intervention groups, using the code given to the patients, the patients with the odd code will be assigned to the first intervention group and the patients with the even code will be assigned into the second intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, clinical caregivers (operating room personnel), outcome elevators (operating room and neurosurgery ward nurses), and data analyzers will be blind to the profile of patients. Blindness will be done by removing the name and surname and other information that will allow access to patient profiles. Patients will be encoded, and this coding is obvious just to the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central Building No. 2, Tabriz University of Medical Sciences, Golghast St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2018-08-06, 1397/05/15
Ethics committee reference number
IR. TBZMED. REC. 1397. 389
Health conditions studied
1
Description of health condition studied
Cerebral anterior circular aneurysm
ICD-10 code
I67.1
ICD-10 code description
Cerebral aneurysm, nonruptured
Primary outcomes
1
Description
Post-operative mortality rate
Timepoint
Two weeks after intervention
Method of measurement
Questionnaire on postoperative complications
Secondary outcomes
1
Description
Post-surgical complications frequency
Timepoint
Intervention day, Four weeks after intervention
Method of measurement
Questionnaire on postoperative complications
2
Description
Re-bleeding frequency
Timepoint
Intervention day, Four weeks after intervention
Method of measurement
Questionnaire on postoperative complications
3
Description
Aneurysm wall improvement frequency
Timepoint
Intervention day, Four weeks after intervention
Method of measurement
Questionnaire on postoperative complications
Intervention groups
1
Description
Intervention group 1: In coiling intervention, composite springs are used to fill the aneurysm and remove it from the main circulation system. In this method, the neurosurgeon initially slices in the arterial arm or leg of the patient, and then sends the catheter to the brain and to the vascular aneurysm. The neurosurgeon then inserts a soft wire spring into the vascular aneurysm. This spring corrects blood flow and forms a blood clot that acts as a vascular aneurysm cushion and prevents it from bursting.
Category
Treatment - Surgery
2
Description
Intervention group 2: In this method, coiling is done with clipping. Composite springs are used to fill the aneurysm and remove it from the main circulation system. In this method, the neurosurgeon initially slices in the arterial arm or leg of the patient, and then sends the catheter to the brain and to the vascular aneurysm. The neurosurgeon then inserts a soft wire spring into the vascular aneurysm. This spring corrects blood flow and forms a blood clot that acts as a vascular aneurysm cushion and prevents it from bursting. Clips are then used to restrict the artery wall to perform Clipping.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Ward of Emem Reza hospital
Full name of responsible person
Ramin Tutakhaneh Bonab
Street address
Emam Reza Hospital, Daneshgah Ave, Pishghadam
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
info@imamreza.tbzmed.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ghaffar Shokuhi Tabrizi
Street address
Vice Chancellor for Research, Faculty of Medicine, Gholghasht Street, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 6923
Email
shokuhi.gh@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?