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IRCT20211130053232N1 IRCT 2022-01-09 Kerman University of Medical Sciences Evaluation of treatment of chronic cerebral hemorrhage by siphon method in patients referred to Bahonar Hospital in Kerman Evaluation of treatment of chronic subdural hemorrhage by siphon method in patients referred to Bahonar Hospital in Kerman 2022-01-21 anticipated 60 Complete https://irct.ir/trial/60342 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, sampling is first available and then eligible patients will be randomly assigned to two groups. For this purpose, first a random sequence will be created from the table of random numbers. Then the extracted even numbers will be assigned to the siphon group and the odd numbers will be assigned to the burr hole group. This process will continue to reach the sample size, Blinding description: Blinding is two-way blind so that the participant and the physician evaluating the outcome and the data analyzer are unaware of the type of surgical procedure And only the surgeon will know the type of operation. 3 Subdural hemorrhage. Intervention 1: Intervention group: Siphon craniostomy, first the burr hole is placed and then after opening the Dura by placing the catheter in the part of the hematoma that is the largest and lower volume, continuously by pouring saline into the burr hole from the catheter. The distal head is located below the patient's head. The chronic hematoma is continuously drained until clear fluid comes out. Finally, after ventilating and fixing the catheter, the skin is closed and a drain is placed at the level of the head. burr hole method: In each patient a 16 mm diameter burr hole is created in the convexity of the skull under general anesthesia. The dura and outer membrane are incised and the hematoma cavity is flushed with warm physiological saline until clear fluid is removed and the space is filled with isotonic saline, then the drain is placed in the empty space. Intervention 2: Control group: burr hole craniostomy, In each patient a burr hole is created in the skull. The dura and outer membrane are incised and the hematoma cavity is washed with physiological saline until clear fluid is removed, and the space is filled with isotonic saline, then the drain is placed in the empty space. Yes - There is a plan to make this available What will be shared: At the end of the study, some of the information, including side effects, the consequences of the surgical procedure after unrecognizing individuals, will be shared with health care professionals. When: 2 months after data analysis To whom: Health researchers Conditions: In order to use the results and during the written request Where to obtain: Mohammad Agha Mohammadi- Email How to obtain: The purpose of accessing data - requesting e-mail- Information will be sent a week after the request Comments:
public Mohammad Agha Mohammadi
Gharani
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 drmohammadi24@gmail.com Kerman University of Medical Sciences scientific Hamed Reyhani
Gharani
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 reyhani@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Chronic subdural hemorrhage for more than 72 hours Decrease GCS Neurological deficits Gait disorder no limit no limit Both Patient dissatisfaction in participating in the study Taking anticoagulants History of craniocerebral surgery Rebleeding after burr hole craniostomy I62.03 Nontraumatic chronic subdural hemorrhage Treatment - Surgery Treatment - Surgery Intervention group: Siphon craniostomy, first the burr hole is placed and then after opening the Dura by placing the catheter in the part of the hematoma that is the largest and lower volume, continuously by pouring saline into the burr hole from the catheter. The distal head is located below the patient's head. The chronic hematoma is continuously drained until clear fluid comes out. Finally, after ventilating and fixing the catheter, the skin is closed and a drain is placed at the level of the head. burr hole method: In each patient a 16 mm diameter burr hole is created in the convexity of the skull under general anesthesia. The dura and outer membrane are incised and the hematoma cavity is flushed with warm physiological saline until clear fluid is removed and the space is filled with isotonic saline, then the drain is placed in the empty space. Control group: burr hole craniostomy, In each patient a burr hole is created in the skull. The dura and outer membrane are incised and the hematoma cavity is washed with physiological saline until clear fluid is removed, and the space is filled with isotonic saline, then the drain is placed in the empty space. Treatment of chronic subdural hemorrhage by siphon method. Timepoint: 12 months. Method of measurement: Checklist and examination. Kerman University of Medical Sciences Approved 2021-11-23 Ethics committee of Kerman University of Medical Sciences Kerman,The beginning of Haft Bagh Alavi Road, Kerman University of Medical Sciences Campus Kerman Kerman Iran (Islamic Republic of)