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IRCT20120527009878N4 IRCT 2018-11-03 Tabriz University of Medical Sciences Comparison of surgical methods in the treatment of cerebral arteries aneurysms Comparison of surgical clipping and interventional coiling in the progressive anterior circulation aneurysms of brain. 2018-08-11 anticipated 120 Complete https://irct.ir/trial/33277 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Cerebral anterior circular aneurysm. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: Available after publication. To whom: All Physicians and residents of the neurosurgery department Conditions: After obtaining permission from the neurosurgery department Where to obtain: Person who responsible for scientific accountability of study. How to obtain: After approval of the research vice-president. Comments:
public Dr. Firoz Salehpoor
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1334 0830 salehpourf@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Firoz Salehpoor
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 salehpourf@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both Glasgow coma scale (GCS) less than 8 Giant's aneurysms larger than 10 mm Desiccant aneurysms I67.1 Cerebral aneurysm, nonruptured Treatment - Surgery Treatment - Surgery 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. 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. Post-operative mortality rate. Timepoint: Two weeks after intervention. Method of measurement: Questionnaire on postoperative complications. Post-surgical complications frequency. Timepoint: Intervention day, Four weeks after intervention. Method of measurement: Questionnaire on postoperative complications. Re-bleeding frequency. Timepoint: Intervention day, Four weeks after intervention. Method of measurement: Questionnaire on postoperative complications. Aneurysm wall improvement frequency. Timepoint: Intervention day, Four weeks after intervention. Method of measurement: Questionnaire on postoperative complications. Tabriz University of Medical Sciences Approved 2018-08-06 Ethics committee of Tabriz University of Medical Sciences Central Building No. 2, Tabriz University of Medical Sciences, Golghast St Tabriz East Azarbaijan Iran (Islamic Republic of)