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IRCT20210825052290N1 IRCT 2021-12-06 Iran University of Medical Sciences The effectiveness of aspirin in preventing DVT after lumbar canal stenosis Surgeries Evaluation of the effectiveness of aspirin in preventing DVT after lumbar spinal stenosisSurgeries 2022-01-21 anticipated 102 Complete https://irct.ir/trial/60210 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random chain construction of two groups of 51 A (intervention group) and B (control group) using Excel software will be used. In a column of 51 letters A and 51 letters B and in the adjacent column with the Rand command, make 102 random numbers. Arrange both columns in random order from large to small. The sequence of letters A and B will be the random sequence used, Blinding description: Patients are randomly assigned to intervention and control groups. In such a way that patients, the prescribing physician, and the analyzer will be blind to the groups that have received the drug or placebo. 3 Deep Vein Thrombosis. Intervention 1: Intervention group: Candidates for decompression stenosis surgery who will receive 325 mg oral aspirin twice daily for 3 weeks after surgery. Intervention 2: Control group: Yamaran is a candidate for canal stenosis decompression surgery who will receive oral placebo twice a day for 3 weeks after surgery. Yes - There is a plan to make this available What will be shared: Unidentifiable personal data of participants will be shared upon request upon completion of the study. The protocol of surgery and study will be provided to the researchers in the form of a report after the end of the study. Statistical analysis of the data of this study will be shared in the form of a report after the end of the study. Informed design consent form, study clinical reports and codes used in the analysis will be shared in the form of a report at the end of the study. Part of the data, such as information about the main outcome or the like, will be published collectively without identifying individuals in the form of an article When: 6 months after printing the results To whom: University researchers Conditions: Use to promote knowledge and researchers without permission to manipulate documents Where to obtain: corresponding How to obtain: Send a written request and then review and if the request is approved, the documents will be delivered. (Maximum one month) Comments:
public Ali Habibollahzadeh
Tehran, Baharestan Square, Mojahedin-e-Islam St., Shafayehiaian Educational and Medical Center
Tehran Iran (Islamic Republic of) 3713111576 +98 21 3354 2001 alihabibollahzadeh.ortho@gmail.com Iran University of Medical Sciences scientific Mohamadrez shakeri
Tehran, Baharestan Square, Mojahedin-e-Islam St., Shafayehiaian Educational and Medical Center
Tehran Iran (Islamic Republic of) 3713111576 +98 21 3354 2001 mshakeri3116@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) All patients over 40 years of age who have undergone decompression of spinal canal stenosis Patients' informed consent 40 years no limit Both Prohibition of aspirin use Concomitant musculoskeletal diseases including severe osteoarthritis, rheumatoid arthritis, fibromyalgia I82.4 Acute embolism and thrombosis of deep veins of lower extremity Prevention Placebo Intervention group: Candidates for decompression stenosis surgery who will receive 325 mg oral aspirin twice daily for 3 weeks after surgery. Control group: Yamaran is a candidate for canal stenosis decompression surgery who will receive oral placebo twice a day for 3 weeks after surgery. Frequency of DVT after lumbar spinal stenosis. Timepoint: After the intervention and 3 months after taking aspirin. Method of measurement: Intravenous color Doppler ultrasound. Iran University of Medical Sciences Approved 2021-11-21 Ethics committee of Iran University of Medical Sciences Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)