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IRCT20230815059152N1 IRCT 2023-09-11 Shahid Beheshti University of Medical Sciences Investigating the effect of intravenous iron injection in spine surgery Investigating the relationship between intravenous iron injection before spinesurgery in patients and improving perioperative outcomes, a randomized clinical trila. 2023-05-24 anticipated 60 Complete https://irct.ir/trial/72269 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Blinding description: The aforementioned study is a double-blind clinical trial, as follows: 1) The statistical analyst is outside the treatment team, and it is not clear to them whether group A, B or C has been subjected to intervention and the information of each of the three groups without being told in which of the groups the intervention took place. has been accepted and will be available to them. 2) The neurosurgery assistant present during the operation, (who is present as a clinical supervisor)so that all three groups of patients will undergo posterior instrumentation surgery, as well as the same surgical technique and the possibility of deviation by the surgeon during the operation, they are informed that this The patients are in the study, but they are not told which of the patients have undergone intravenous iron injection and intervention. 3 After posterior fusion surgery of lumbar vertebrae. The patients in the mentioned clinical trial study are in three groups (A), (B) and (C). All the patients who entered the Madaleh have signed a written consent form to perform the intervention and have received full explanations. Group (a) are those patients who have anemia in laboratory results before surgery, i.e. hemoglobin less than 13 gm/dL for men and less than 12 mg/dL for women. and they are supposed to undergo the intervention of intravenous iron injection. Group (b) are those patients who do not have anemia in laboratory tests before surgery and are supposed to undergo the intervention of intravenous iron injection,Group (c) is the control group that does not undergo the intervention of intravenous iron injection.Venofer intravenous iron comes in the form of vials containing 500 mg of iron, which is injected into the patient in 1000 cc of normal saline over a period of 15 minutes to 1 hour. Intravenous iron injection is done 24 hours before surgery in these patients. Before the injection, the patients' hemoglobin and ferritin levels are checked and recorded in laboratory tests. After surgery, laboratory tests are repeated at intervals of 1 day, 14 days, and then 28 days, and their levels are also recorded. Also, during hospitalization, patients are checked for the occurrence of infection at the operation site and also the duration of hospitalization. On the 28th day, the patients undergo a routine follow-up CT scan or a simple photo of the abdomen, and with the help of the Lenke criteria, we can classify the degree of swelling of the patients.All information and data are presented to a statistical expert for analysis. It should be noted that the statistical analyst is outside the treatment team and is blinded to the intervention. Also, neurosurgery assistants who are present during the surgery to prevent bias. The precision and technique during the operation is blind to the intervention.. Yes - There is a plan to make this available What will be shared: Duration of hospitalization from before operation to after Number of operated tubes Is there an infection at the surgical site or not? What was the initial and final hemoglobin level? Has it dropped or not? Are the changes meaningful? When: From 1403 To whom: Researchers working in academic institutions Conditions: Natural and legal persons with university faculty status Where to obtain: Farzan Fahim, mobile number 09120943182, email address farzn.fahim@gmail.com How to obtain: First, send an email with your complete introduction, then the answer will be sent within 24 hours. Comments:
public farzan fahim
Nirvana Building, No. 1, corner of 16th St., in front of the fire station, Volenjak St.
Tehran Iran (Islamic Republic of) 1985743855 +98 21 2680 0765 farzn.fahim@gmail.com Shahid Beheshti University of Medical Sciences scientific farzan fahim
Nirvana Building, No. 1, corner of 16th St., in front of the fire station, Volenjak St.
Tehran Iran (Islamic Republic of) 1985743855 +98 21 2680 0765 farzn.fahim@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age range from 18 to 70years Patients undergoing posterior vertebral fusion surgery at least 3 levels 18 years 70 years Both History of iron sensitivity Under 18 years and over 70 years known Cirrhosis of the liver known Thalassemia major Ferritin more than 300 ng/dl known Thalassemia Intermedia known Hemosiderosis known Active phase of nutritional deficiency Treatment - Drugs The patients in the mentioned clinical trial study are in three groups (A), (B) and (C). All the patients who entered the Madaleh have signed a written consent form to perform the intervention and have received full explanations. Group (a) are those patients who have anemia in laboratory results before surgery, i.e. hemoglobin less than 13 gm/dL for men and less than 12 mg/dL for women. and they are supposed to undergo the intervention of intravenous iron injection. Group (b) are those patients who do not have anemia in laboratory tests before surgery and are supposed to undergo the intervention of intravenous iron injection,Group (c) is the control group that does not undergo the intervention of intravenous iron injection.Venofer intravenous iron comes in the form of vials containing 500 mg of iron, which is injected into the patient in 1000 cc of normal saline over a period of 15 minutes to 1 hour. Intravenous iron injection is done 24 hours before surgery in these patients. Before the injection, the patients' hemoglobin and ferritin levels are checked and recorded in laboratory tests. After surgery, laboratory tests are repeated at intervals of 1 day, 14 days, and then 28 days, and their levels are also recorded. Also, during hospitalization, patients are checked for the occurrence of infection at the operation site and also the duration of hospitalization. On the 28th day, the patients undergo a routine follow-up CT scan or a simple photo of the abdomen, and with the help of the Lenke criteria, we can classify the degree of swelling of the patients.All information and data are presented to a statistical expert for analysis. It should be noted that the statistical analyst is outside the treatment team and is blinded to the intervention. Also, neurosurgery assistants who are present during the surgery to prevent bias. The precision and technique during the operation is blind to the intervention. Duration of hospitalization after surgery. Timepoint: The beginning of the study and the end of the study. Method of measurement: Counting down the days. Incidence of infection. Timepoint: Day 0 until the end of hospitalization. Method of measurement: Qualitative. The degree of fusion of the vertebrae with an interval of one month after the operation. Timepoint: one month after the operation. Method of measurement: lenke scale. Hemoglobin drop after surgery. Timepoint: Immediately after surgery, 14 days and then 28 days after surgery. Method of measurement: laboratory. Shahid Beheshti University of Medical Sciences Approved 2023-08-27 Ethics Committee of Shahid Beheshti University of Medical Sciences Volenjek St., in front of the fire station, corner of 16th St., Nirvana Building, No. 1 Tehran Tehran Iran (Islamic Republic of)