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IRCT20151123025202N27 IRCT 2023-01-02 Hamedan University of Medical Sciences Cervical disc surgery by macroscopic and microscopic methods دیسکتومی Comparison of macroscopic and microscopic surgical methods in patients undergoing anterior cervical discectomy 2023-01-05 anticipated 60 Complete https://irct.ir/trial/67280 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We made 60 cards and write letters MA on 30 for macroscopy and on the other 30 letters MI for the microscopy group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, randomly select one of the envelopes and open it, based on selected letter ( MA or MI) patients assign it to the macroscopy or microscopy discectomy , Blinding description: The person who will assess the pain score and other outcomes of the surgery will be blinded of the surgical procedure. 3 cervical disc. Intervention 1: Intervention group: They will undergo macroscopic surgery.In the macroscopic method, the cervical spine is accessed through the front. The skin and platysma muscle will be opened and the vertebral column is accessed from the space between the sternocleidomastoid on the side and the mid-cervical structures (trachea and esophagus) in the middle. In this method, the entire injured disc and the osteophytes will be removed, and a bone graft is placed in the space of the removed disc. Intervention 2: Control group: They will undergo microscopic surgery. In this procedure, first, a small incision is made at the back of the neck (midline). By removing the muscle, access to the desired vertebra will be provided. In order to ensure the exact location of the surgery, an X-ray is performed before removing the disc. Then, in order to determine the root of the nerve, a part of the facet joint is removed, finally, using a microscope, the disc under the root is identified and the herniated disc is removed. The nerve root will be returned. The muscles will move back and the incision will be sutured. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Abbas Moradi
Shahid fahmideh street Medical school
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0097 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences scientific Mahdi Arjipour
Hamedan shahid fahmideh street medicine school
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0572 m.arjipour@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Non-traumatic cervical discopathy Discopathy less than three levels no limit 70 years Both Presence of posterior ligament calcification Age > 70 years M50 Cervical disc disorders Treatment - Surgery Treatment - Surgery Intervention group: They will undergo macroscopic surgery.In the macroscopic method, the cervical spine is accessed through the front. The skin and platysma muscle will be opened and the vertebral column is accessed from the space between the sternocleidomastoid on the side and the mid-cervical structures (trachea and esophagus) in the middle. In this method, the entire injured disc and the osteophytes will be removed, and a bone graft is placed in the space of the removed disc. Control group: They will undergo microscopic surgery. In this procedure, first, a small incision is made at the back of the neck (midline). By removing the muscle, access to the desired vertebra will be provided. In order to ensure the exact location of the surgery, an X-ray is performed before removing the disc. Then, in order to determine the root of the nerve, a part of the facet joint is removed, finally, using a microscope, the disc under the root is identified and the herniated disc is removed. The nerve root will be returned. The muscles will move back and the incision will be sutured. Pain severity change. Timepoint: 24 4 hours after surgery. Method of measurement: Neck pain Visual Analog Scale (NP-VAS). Analgesic consumption. Timepoint: during 24 hours postoperative. Method of measurement: Extract from the patient's medical record. Complications of bleeding, septicemia, dysphagia. Timepoint: During the operation and up to 24 hours after the operation. Method of measurement: Surgeon's report, clinical examination and review of patients' medical records. Hospitalization period. Timepoint: at discharge time. Method of measurement: Interval time between hospitalization and discharge. Hamedan University of Medical Sciences Approved 2022-12-03 Ethics committee of Hamadan Univercity of Medical Science shahid fahmideh avenue Hamadan Hamadan Iran (Islamic Republic of)