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IRCT20220822055773N1 IRCT 2022-08-31 Tehran University of Medical Sciences Comparative evaluation of surgical result of sonographic assisted minimally invasive parathyroidectomy And conventional parathyroidectomy in primary hyparathyroidisem patients Comparative evaluation of surgical result of sonographic assisted minimally invasive parathyroidectomy And conventional parathyroidectomy in primary hyparathyroidisem patients 2016-08-22 anticipated 96 Complete https://irct.ir/trial/65477 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: It is simple, a number was assigned to each patient, then they were placed in the online platform www.randomization.com to randomize the number, and two groups A and B were randomized as intervention and control groups. Randomization Unit: Individual Output of the random instrument: patients with primary hyperthyroidism who have been definitively diagnosed clinically and laboratory, both male and female, without age limit. 3 surgical result of sonographic assisted minimally invasive parathyroidectomy And conventional parathyroidectomy in primary hyparathyroidisem patients. Intervention 1: Intervention group: In this study, the patients entered the study after being selected based on the entry and exit criteria, then pre-operative tests and examinations for MIP (minimally invasive parathyroidectomy) candidates, including ultrasound examination to localize the overactive parathyroid and serum measurement of the PTH hormone level. During the operation and scanning of the parathyroid will be performed and finally the surgery will be performed in a minimally invasive way to remove the overactive parathyroid. Then necessary tests such as PTH measurement before surgical incision, PTH measurement before excision, PTH measurement 5 minutes after excision and finally PTH measurement 10 minutes after excision will be measured. Intervention 2: Control group: In this study, the patients entered the study after being selected based on the entry and exit criteria, then pre-operative tests and examinations for conventional parathyroidectomy candidates, including the serum measurement of the PTH hormone level during the operation and the parathyroid scan, will be performed. Finally, conventional surgery will be performed to remove the overactive parathyroid. Then necessary tests such as PTH measurement before surgical incision, PTH measurement before excision, PTH measurement 5 minutes after excision and finally PTH measurement 10 minutes after excision will be measured. In patients who are candidates for parathyroidectomy by conventional method, parathyroid scan and ultrasound will be used to localize the overactive parathyroid before the operation. Yes - There is a plan to make this available What will be shared: Data will be shared after blinding of datasheet. When: Data will be shared within 6 months after publication. To whom: Data will be accessible for researchers affiliated to universities Conditions: Data can be used for further meta-analysis after permission of the person responsible for this project Where to obtain: Data request should be sent through email for the person responsible for this project. Dr. Shirzad Nasiri Zivaki Dr.sh.nasiri@gmail.com How to obtain: Following the primary request, all the researchers will be informed by the responsible person and after permission the data will be shared. Comments:
public Shirzad Nasiri Zaviki
Jalal Al Ahmad Three Roads, North Kargar St.,
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8863 3039 Dr.sh.nasiri@gmail.com Tehran University of Medical Sciences scientific Shirzad Nasiri Zaviki
Jalal Al Ahmad Three Roads, North Kargar St.,
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8863 3039 Dr.sh.nasiri@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with primary hyperthyroidism no limit no limit Both Patients whose parathyroid tumor is more than 4 cm The presence of any chronic disease or malignancy in the thyroid or parathyroid region or suffering from any systemic and malignant disease Patients with secondary or tertiary hyperthyroidism E21.0 Primary hyperparathyroidism Treatment - Surgery Treatment - Surgery Intervention group: In this study, the patients entered the study after being selected based on the entry and exit criteria, then pre-operative tests and examinations for MIP (minimally invasive parathyroidectomy) candidates, including ultrasound examination to localize the overactive parathyroid and serum measurement of the PTH hormone level. During the operation and scanning of the parathyroid will be performed and finally the surgery will be performed in a minimally invasive way to remove the overactive parathyroid. Then necessary tests such as PTH measurement before surgical incision, PTH measurement before excision, PTH measurement 5 minutes after excision and finally PTH measurement 10 minutes after excision will be measured. Control group: In this study, the patients entered the study after being selected based on the entry and exit criteria, then pre-operative tests and examinations for conventional parathyroidectomy candidates, including the serum measurement of the PTH hormone level during the operation and the parathyroid scan, will be performed. Finally, conventional surgery will be performed to remove the overactive parathyroid. Then necessary tests such as PTH measurement before surgical incision, PTH measurement before excision, PTH measurement 5 minutes after excision and finally PTH measurement 10 minutes after excision will be measured. In patients who are candidates for parathyroidectomy by conventional method, parathyroid scan and ultrasound will be used to localize the overactive parathyroid before the operation. Success of MIP surgery in patients with primary hyperparathyroidism based on changes in serum PTH levels. Timepoint: PTH measurement before surgical incision, PTH measurement before excision, PTH measurement 5 minutes after excision and finally PTH measurement 10 minutes after excision. Method of measurement: Sonographic investigation to localize overactive parathyroid and serum level of PTH during surgery and parathyroid scan. Tehran University of Medical Sciences Approved 2016-08-22 Tehran university of medical sciences ethics committee Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)