Protocol summary

Study aim
Investigating the effect of topical dexamethasone in the thyroid surgery site (on the parathyroids) on blood calcium levels after surgery, compared to the control group in patients who underwent total thyroidectomy.
Design
Clinical trial with control group, with parallel groups, randomized, phase 3 on 60 patients. A table of random numbers was used for randomization.
Settings and conduct
The current study is a randomized clinical trial with a before and after design. The statistical population under investigation is all total thyroidectomy candidate patients referred to Imam Khomeini Hospital in 1401, who will be divided into two groups of 30 people using a random number table after determining the inclusion and exclusion criteria. In the case group, after thyroidectomy in the same operating room, an ampoule of dexamethasone (8 mg-2 ml) will be sprayed at the thyroidectomy site, and no special action will be taken in the control group. The investigated times will be before thyroidectomy, 6 hours, 24 hours and 48 hours after thyroidectomy. The data collection tool is a questionnaire, and the data will be entered into SPSS version 22 software after collection.
Participants/Inclusion and exclusion criteria
Inclusion: patients with confirmed thyroid cancer, do not take calcium containing drugs and any corticosteroid drugs, have no history of thyroid or parathyroid surgery. Exclusion: Patients who needed re-operation before 48 hours due to surgical complications such as hematoma at the operation site.
Intervention groups
In the case group, after thyroidectomy in the same operating room, an ampoule of dexamethasone (8 mg-2 ml) will be sprayed at the thyroidectomy site, and no special action will be taken in the control group. The times examined in our study will be before thyroidectomy, 6 hours, 24 hours and 48 hours after thyroidectomy.
Main outcome variables
Blood calcium level.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230323057764N1
Registration date: 2023-05-10, 1402/02/20
Registration timing: prospective

Last update: 2023-05-10, 1402/02/20
Update count: 0
Registration date
2023-05-10, 1402/02/20
Registrant information
Name
Seyyed Mohammad Hossein Mousavi Beyuki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5724 8098
Email address
txhosseinmoosavi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of topical dexamethasone at the site of thyroid surgery (on the parathyroids) on blood calcium levels after surgery, compared to the control group in patients who underwent total thyroidectomy.
Public title
The effect of local spraying of dexamethasone in the thyroid site after thyroidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with confirmed thyroid cancer who need total thyroidectomy Patients who do not take calcium-containing drugs Patients who do not use any corticosteroid medication Patients who had no history of thyroid or parathyroid surgery
Exclusion criteria:
Patients who require re-operation before 48 hours due to surgical complications such as hematoma at the operation site
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the sample size is 60 people, which is less than 100. If people are divided between 2 groups by simple random method. According to the rule of randomization of taps and lines, the number of taps and lines may not be equal in two groups. Therefore, the Block-Randomization method is used. The sample size calculated in this study is 30 people in each group. Therefore, 10 blocks of 4 people are formed and 5 blocks are randomly assigned to each group. As a result, the balance between the two groups is allocated in the form of 30 people to one group and another 30 people to the second group. A simple random method is used to assign people to each block. It means that people are placed in one of these blocks based on a table of random numbers
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences Headquarters, Qods Corner, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.452

Health conditions studied

1

Description of health condition studied
Investigating the effect of topical dexamethasone at the site of thyroid surgery (on the parathyroids)
ICD-10 code
E21.4
ICD-10 code description
Other specified disorders of parathyroid gland

Primary outcomes

1

Description
Blood calcium level
Timepoint
Before thyroidectomy
Method of measurement
Based on the patient's file

Secondary outcomes

1

Description
Blood calcium level
Timepoint
Before thyroidectomy, 6 hours, 24 hours and 48 hours after thyroidectomy
Method of measurement
Based on the patient's file

Intervention groups

1

Description
Intervention group: after performing thyroidectomy in the same operating room, an ampoule of dexamethasone (8 mg-2 ml) will be sprayed at the thyroidectomy site.
Category
Treatment - Drugs

2

Description
Control group: no special action will be taken after thyroidectomy.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Seyyed Mohammad Hossein Mousavi Beyuki
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Street, at the end of Keshavarz Boulevard, Tehran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6405 3334
Email
Imamhospital@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Imam Khomeini Hospital Complex, at the end of Keshavarz Boulevard, Dr. Gharib Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8899 2970
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Hossein Mousavi Beyuki
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Hospital Complex, at the end of Keshavarz Boulevard, Dr. Gharib Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 5724 8098
Fax
Email
txhosseinmoosavi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Hossein Mousavi Beyuki
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Hospital Complex, at the end of Keshavarz Boulevard, Dr. Gharib Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 5724 8098
Fax
Email
txhosseinmoosavi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Hossein Mousavi Beyuki
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Hospital Complex, at the end of Keshavarz Boulevard, Dr. Gharib Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 5724 8098
Fax
Email
txhosseinmoosavi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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