]>
IRCT20221108056446N12 IRCT 2025-01-15 Esfahan University of Medical Sciences Topical steroid during anterior cervical discectomy with fusion in preventing dysphagia Investigating the effectiveness of intraoperative topical steroids in preventing dysphagia and swallowing disorders in patients undergoing anterior cervical discectomy surgery with fusion 2025-01-20 anticipated 120 Complete https://irct.ir/trial/80960 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: With the convenience sampling method, the referring individuals who are eligible for the study are randomly divided into two groups: case and control. In this study, the division of individuals is done using the four-way permutation block method. In this method, A represents the individual who receives the intervention and B represents the individual who is in the control group. Considering the four-way block, we give the AABB permutation code 0, the ABAB permutation code 1, ABBA code 2, BAAB code 3, BBAA code 4, and BABA codes 5 to 9. Then, using the random number table, we randomly select a starting point and then consider the numbers in rows or columns. Considering the order of the numbers in the table, we assign the corresponding permutation to each number we encounter. Finally, 120 people will be divided into two groups. 2 Cervical disc. Intervention 1: Intervention group: For patients in the intervention group (60 patients), depomedrol is administered. 5 cc of depomedrol is required for each gelfoam. In fact, a gelfoam measuring 4 x 2 cm is completely soaked. Intervention 2: Control group: For patients in the control group (60 patients), normal saline is administered. 5 cc of normal saline is required for each gelfoam. In fact, a gelfoam measuring 4 x 2 cm is completely soaked. 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 No more information available.
public Mehdi Shafiei
Sofeh Street
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 mui@mui.ac.ir Esfahan University of Medical Sciences scientific Mehdi Shafiei
Sofeh Street
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 mui@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) The patient must consent to participate in the study. The patient has undergone anterior discectomy with fusion. no limit no limit Both Patients who have undergone surgery with traumatic, neoplastic, or infectious symptoms Patients who had previously received corticosteroids (6 months ago). M43.22 Fusion of spine, cervical region Prevention Prevention Intervention group: For patients in the intervention group (60 patients), depomedrol is administered. 5 cc of depomedrol is required for each gelfoam. In fact, a gelfoam measuring 4 x 2 cm is completely soaked. Control group: For patients in the control group (60 patients), normal saline is administered. 5 cc of normal saline is required for each gelfoam. In fact, a gelfoam measuring 4 x 2 cm is completely soaked. Dysphagia. Timepoint: Data is collected before surgery and at 1 day, 2 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery. Method of measurement: Patient examination. Esfahan University of Medical Sciences Approved 2024-12-24 Esfahan University of Medical Sciences Hazar Jarib Street, Azadi Square Esfahan Isfehan Iran (Islamic Republic of)