Comparative evaluation of surgical result of sonographic assisted minimally invasive parathyroidectomy And conventional parathyroidectomy in primary hyparathyroidisem patients
Determining the size and approximate location of the parathyroid to reduce surgery time and complications of minimally invasive parathyroidectomy with the help of ultrasound (MIP sono assisted) compared to conventional parathyroidectomy.
Design
Patients with primary hyperparathyroidism due to parathyroid adenoma who underwent minimally invasive parathyroidectomy will form the study population. The group that underwent surgery with the conventional method forms the control group.
Settings and conduct
The study of a randomized clinical trial on patients with primary hyperparathyroidism due to parathyroid adenoma who underwent minimally invasive parathyroidectomy surgery at Shariati Hospital will form the study group, and the group that underwent conventional surgery form the control group.
Participants/Inclusion and exclusion criteria
Inclusion: Patients with primary hyperthyroidism
exclusion : 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
Intervention groups
In the intervention group, parathyroidectomy was performed minimally invasively with the help of ultrasound.
In the control group, parathyroidectomy was performed conventionally.
Main outcome variables
PTH drop more than 50% before and after excision
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220822055773N1
Registration date:2022-08-31, 1401/06/09
Registration timing:retrospective
Last update:2022-08-31, 1401/06/09
Update count:0
Registration date
2022-08-31, 1401/06/09
Registrant information
Name
shirzad nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2450
Email address
dr.sh.nasiri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
2016-09-10, 1395/06/20
Actual recruitment end date
2016-12-10, 1395/09/20
Trial completion date
2017-03-18, 1395/12/28
Scientific title
Comparative evaluation of surgical result of sonographic assisted minimally invasive parathyroidectomy And conventional parathyroidectomy in primary hyparathyroidisem patients
Public title
Comparative evaluation of surgical result of sonographic assisted minimally invasive parathyroidectomy And conventional parathyroidectomy in primary hyparathyroidisem patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with primary hyperthyroidism
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences ethics committee
Street address
Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.TUMS.REC.1395.2661
Health conditions studied
1
Description of health condition studied
surgical result of sonographic assisted minimally invasive parathyroidectomy And conventional parathyroidectomy in primary hyparathyroidisem patients
ICD-10 code
E21.0
ICD-10 code description
Primary hyperparathyroidism
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Surgery
2
Description
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.