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IRCT20220530055031N5 IRCT 2024-06-10 Tehran University of Medical Sciences Investigation of different calcium treatment regimens on patients after thyroidectomy Comparative Evaluation of the Impact of Routine Calcium intake versus Recommended Calcium Intake in Patients Undergoing Total Thyroidectomy 2024-05-30 anticipated 140 Complete https://irct.ir/trial/76946 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to one of 2 treatment groups by block randomization method. Block randomization with different block sizes is used for random allocation. Block sizes are multiples of 2. Initially, block sizes are randomly selected. Finally, one of the different permutations is determined for the equal group size. Random numbers are done using Excel. The study will be done blindly. In such a way that the patients do not know the type of supplement received and the drugs are given to the patients in the same packaging without specifying the specifications, and only the researcher knows the type of drug prescribed and the doctor and the person in charge of evaluating the patients who talk to the patient, They do not know the prescribed medicine, Blinding description: With the help of getting random numbers using Excel for each patient. The study will be done blindly. In such a way that the patients do not know the type of supplement received and the drugs are given to the patients in the same packaging without any specifications, and only the researcher knows the type of drug prescribed and the doctor and the person in charge of evaluating the patients who talk to the patient about the type of drug Prescribed do not know. N/A Hypocalcemia after total thyroidectomy surgery. Intervention 1: intervention group: In this group, they will be treated with a high-dose calcium regimen (500 mg calcium carbonate every 8 hours, 0.5 microgram calcitriol 1 tablet every 12 hours, and 500 mg calcifort every 6 hours) after surgery. The calcium level of patients will be checked 12 hours before surgery and 8 hours after surgery, and every 8 hours after surgery, patients will be checked for signs and symptoms of hypocalcemia and serum calcium level. The presence and absence of symptoms are collected in the checklist. Patients are discharged if there are no hypocalcemic symptoms and normocalcemic serum. Patients will return to the clinic for clinical examinations 5 days after the operation, and the serum calcium level of the patients will be checked again. Intervention 2: Control group: A group of patients received only routine treatment (500 mg of calcium every 8 hours and 1000 units of calcitriol daily) after surgery. The calcium level of patients will be checked 12 hours before surgery and 8 hours after surgery, and every 8 hours after surgery, patients will be checked for signs and symptoms of hypocalcemia and serum calcium level. The presence and absence of symptoms are collected in the checklist. Patients are discharged if there are no hypocalcemic symptoms and normocalcemic serum. Patients will return to the clinic for clinical examinations 5 days after the operation, and the serum calcium level of the patients will be checked again. 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 Seyed Amir Miratashi Yazdi
Imam khomeini ave. sina hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 amiratahi@tums.ac.ir Tehran University of Medical Sciences scientific Seyed Amir Miratashi Yazdi
Imam khomeini ave,. sina hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 amiratahi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Potential early diagnosis of thyroid cancer total thyroidectomy With or without the spread of cancer to the lateral parts of the neck Absence of hypercalcemia before surgery or any kind of kidney disorder that causes calcium metabolism disorder Absence of abnormal preoperative parathyroid hormone levels or concomitant parathyroid diseases No history of any type of thyroid or neck surgery Age over 18 years 18 years no limit Both Pathological diagnosis after surgery except papillary thyroid cancer Patients who have a history of taking calcium supplements before surgery History of kidney or urinary tract disease History of radiation therapy or other tumors E83.51 Hypocalcemia Treatment - Drugs Treatment - Drugs intervention group: In this group, they will be treated with a high-dose calcium regimen (500 mg calcium carbonate every 8 hours, 0.5 microgram calcitriol 1 tablet every 12 hours, and 500 mg calcifort every 6 hours) after surgery. The calcium level of patients will be checked 12 hours before surgery and 8 hours after surgery, and every 8 hours after surgery, patients will be checked for signs and symptoms of hypocalcemia and serum calcium level. The presence and absence of symptoms are collected in the checklist. Patients are discharged if there are no hypocalcemic symptoms and normocalcemic serum. Patients will return to the clinic for clinical examinations 5 days after the operation, and the serum calcium level of the patients will be checked again. Control group: A group of patients received only routine treatment (500 mg of calcium every 8 hours and 1000 units of calcitriol daily) after surgery. The calcium level of patients will be checked 12 hours before surgery and 8 hours after surgery, and every 8 hours after surgery, patients will be checked for signs and symptoms of hypocalcemia and serum calcium level. The presence and absence of symptoms are collected in the checklist. Patients are discharged if there are no hypocalcemic symptoms and normocalcemic serum. Patients will return to the clinic for clinical examinations 5 days after the operation, and the serum calcium level of the patients will be checked again. Serum calcium level before surgery. Timepoint: The calcium level of patients will be checked 12 hours before surgery and will be collected in the checklist. Method of measurement: The patient's serum calcium level, measured in the laboratory. Serum calcium level after surgery. Timepoint: The calcium level of the patients will be checked every 8 hours after the operation and will be collected in the checklist. Method of measurement: The patient's serum calcium level, measured in the laboratory. Symptoms caused by hypocalcemia. Timepoint: Every 8 hours after the operation, the patients will be checked for signs and symptoms of hypocalcemia and the presence and absence of symptoms will be collected in the checklist. Method of measurement: Expert opinion. Tehran University of Medical Sciences Approved 2024-05-15 Ethics committee of medical faculty of Tehran University of Medical Sciences Room 604, 6th floor, Tehran University of Medical Sciences Central Building, Keshavarz Blvd., Qods St. intersection Tehran Tehran Iran (Islamic Republic of)