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IRCT20221108056446N3 IRCT 2023-07-27 Esfahan University of Medical Sciences lumbar drain in patients with spinal cord injury Investigating the effect of using lumbar drain in patients with spinal cord injury 2023-08-23 anticipated 30 Complete https://irct.ir/trial/71588 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: People are placed in 2 groups by random block method. In this way, the first 2 eligible people are selected and after obtaining consent, they enter to participate in the study. These 2 people are considered as a block of 2 and are sorted according to the last digit of the national code. The treatment methods are specified as A, B, and all combinations of 2 are specified, and after the last surgery, decoding is done for the last block. N/A spinal cord injury. Intervention 1: Intervention group: For this group, a drain is inserted within the first 12 hours after referral and before lumbar surgery. Intervention 2: Control group: Lumbar drain is not inserted in this group before surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Esfahan University of Medical Sciences
kashani street
Esfahan Iran (Islamic Republic of) 83434-81839 +98 31 3233 0091 mahmoodkhani@mui.ac.ir Esfahan University of Medical Sciences scientific Mehdi Mahmoodkhani
Kashani street
Isafahan Iran (Islamic Republic of) 83434-81839 +98 31 3233 0091 mahmoodkhani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who suffer severe spinal cord injury following trauma (according to Asian classification in groups A, B, and C) Consent to participate in the study. 18 years no limit Both Age less than 18 years Lack of patient consent to enter the study No infection Penetrating trauma to the spine Having infiltrative diseases such as metastasis to the spine Presence of factors preventing MRI such as cardiac pacemaker Congenital disorders of the spine Previous history of spine surgery G95.8 Other specified diseases of spinal cord Treatment - Devices Treatment - Devices Intervention group: For this group, a drain is inserted within the first 12 hours after referral and before lumbar surgery. Control group: Lumbar drain is not inserted in this group before surgery. Sensory, motor disorder. Timepoint: Patients are examined one month, three months, six months and twelve months after lumbar drain placement. Method of measurement: Clinical examination of the patient and force measurement of limbs. Esfahan University of Medical Sciences Approved 2023-07-18 Isfahan University of Medical Sciences Hazar Jarib Street, Azadi Square Isfahan Isfehan Iran (Islamic Republic of)