To find the post-thyroidectomy hypocalcemia and effects of pre-op calcium supplements on its incidence.
Design
Two arms parallel-group; randomized trial; single-blinded study with placebo with postoperative assessment.
Settings and conduct
Single blind study where participants were blinded not knowing in which group they fall.
The study was conducted at CMH Bahawalpur, Bahawalpur, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: thyroid swelling whether multinodular or solitary swelling; patients of all ages and genders; patients with normal pre-op calcium levels and with no disease related to calcium levels were included.
Exclusion criteria: patients with deranged calcium levels; patients not undergoing total thyroidectomy; patients with diseases like bone diseases, parathyroid abnormalities, and kidney diseases causing deranged calcium levels; Patients who did not take proper calcium supplements.
Intervention groups
Interventioal Group 1:Giving Pre operative calcium supplements to the patients undergoing total thyroidectomy. In interventional group i made the intervention that gave the patients undergoing surgery pre operatively oral calcium supplements.
Interventional group 2: control group. No intervention done.
Main outcome variables
Recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231016059739N1
Registration date:2023-12-07, 1402/09/16
Registration timing:retrospective
Last update:2023-12-07, 1402/09/16
Update count:0
Registration date
2023-12-07, 1402/09/16
Registrant information
Name
Erisha Komal
Name of organization / entity
Combined Military Hospital, Bahawalpur, Pakistan
Country
Pakistan
Phone
+92 62 2501741
Email address
herwithaniphone@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-01, 1401/06/10
Expected recruitment end date
2023-09-30, 1402/07/08
Actual recruitment start date
2022-09-01, 1401/06/10
Actual recruitment end date
2023-09-30, 1402/07/08
Trial completion date
2023-10-10, 1402/07/18
Scientific title
Post thyroidectomy hypocalcemia and effects of pre-op calcium supplements on its incidence
Public title
"Pre-Op Calcium Supplements and Post-Thyroidectomy Hypocalcemia: An Investigative Study”
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All the pts with thyroid swelling whether multinodular or solitary visiting the hospital
Patients of all ages
Both genders
Patients with normal pre-op calcium levels
No disease related to calcium levels
Exclusion criteria:
All the patients with deranged calcium levels
Patients not undergoing total thyroidectomy
Patients with diseases like bone diseases, parathyroid abnormalities, and kidney diseases causing deranged calcium levels
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
105
Actual sample size reached:
105
Randomization (investigator's opinion)
Randomized
Randomization description
I used compluter generated software SPSS for randomization.
( I first calculated sample size and then using SPSS randomization was done into 2 groups. Then, each subject was allocated the group accordingly.)
Blinding (investigator's opinion)
Single blinded
Blinding description
We had 2 groups. Both groups were told about the calcium supplements and placebo. one group of patients we gave them tablet cotaining calcium supplements and in the other group we gave them placebo made on order by a phamaceutical company similar to original tablet in shape which did not contained any calcium supplements. Patients were not told which medicines they were given. In this way patiets were blinded and thus my study is single blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Combined Military Hospital Bahwalpur.
Street address
Bahawalpur cantt
City
Bahawalpur
Postal code
63100
Approval date
2023-01-19, 1401/10/29
Ethics committee reference number
ERC Ltr No. 1516/EC/04/2023
Health conditions studied
1
Description of health condition studied
Multinodular goiter and other thyroid diseases
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post-thyroidectomy hypocalcemia
Timepoint
02 weeks after intervention
Method of measurement
I used lab kit to measure serum calcium levels post operatively.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: contains the patients who receiveed calcium supplements pre operatively.
Category
Treatment - Drugs
2
Description
Interventional group 2: control group who received nothing.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital
Full name of responsible person
Dr. Erisha Komal
Street address
Bahawalput cantt
City
Bahawalpur
Postal code
63100
Phone
+92 62 2501742
Email
herwithaniphone@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military hospital, Bahawalpur
Full name of responsible person
Dr. Erisha Komal
Street address
Bahawalpur cantt
City
Bahawalpur
Postal code
63100
Phone
+92 345 8704114
Email
herwithaniphone@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military hospital, Bahawalpur
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Combined Military Hospital, Bahawalpur
Full name of responsible person
Erisha Komal
Position
Trainee
Latest degree
Bachelor
Other areas of specialty/work
General Surgery
Street address
Bahawalpur cantt
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 62 2501742
Email
herwithaniphone@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital, Bahawalpur, Pakistan
Full name of responsible person
Erisha Komal
Position
Trainee
Latest degree
Bachelor
Other areas of specialty/work
General Surgery
Street address
Combined military Hospital, Bahawalpur cantt
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 62 2501741
Fax
Email
herwithaniphone@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital, Bahawalpur, Pakistan
Full name of responsible person
Erisha Komal
Position
Trainee
Latest degree
Bachelor
Other areas of specialty/work
General Surgery
Street address
Combined military Hospital, Bahawalpur cantt
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 62 2501741
Fax
Email
herwithaniphone@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
POST THYROIDECTOMY HYPOCALCEMIA AND EFFECTS OF PRE-OP CALCIUM SUPPLEMENTS ON ITS INCIDENCE
When the data will become available and for how long
In january 2024
To whom data/document is available
For people working in institution
Under which criteria data/document could be used
herwithaniphone@gmail.com
From where data/document is obtainable
herwithaniphone@gmail.com
What processes are involved for a request to access data/document