| CTRI Number |
CTRI/2021/09/036735 [Registered on: 22/09/2021] Trial Registered Prospectively |
| Last Modified On: |
17/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A COMPARATIVE STUDY ON THE EFFECTS ON SERUM CALCIUM AND SERUM TSH (thyroid hormone) IN PATIENTS UNDERGOING HEMITHYROIDECTOMY |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON THE EFFECTS ON SERUM CALCIUM AND SERUM TSH IN PATIENTS UNDERGOING HEMITHYROIDECTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Haridas |
| Designation |
Junior resident postgraduate |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of ENT and head and neck surgery
Kasturba hospital,
Manipal, Udupi
MAHE
Madhav nagar
Manipal, Udupi
Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9920447467 |
| Fax |
|
| Email |
aishwaryaharidas9493@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailash Pujary |
| Designation |
Professor, head of unit and head of department |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of ENT and head and neck surgery
Kasturba hospital,
Manipal, Udupi
MAHE
Madhav nagar
Manipal, Udupi
Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845144015 |
| Fax |
|
| Email |
kailesh.pujary@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kailash Pujary |
| Designation |
Professor, head of unit and head of department |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of ENT and head and neck surgery
Kasturba hospital,
Manipal, Udupi
MAHE
Madhav nagar
Manipal, Udupi
Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845144015 |
| Fax |
|
| Email |
kailesh.pujary@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Institutional thesis research grant |
| Self funded |
|
|
Primary Sponsor
|
| Name |
Institutional thesis research grant |
| Address |
Kasturba medical college, MAHE
Tiger circle road, Madhav Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self funded |
Dr Aishwarya Haridas
Department of ENT and head and neck surgery
Kasturba hospital, Manipal
Karnataka 576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aishwarya Haridas |
Kasturba hospital |
Department of ENT and department of General Surgery
Kasturba hospital, MAHE
Tiger circle road, Manipal
Udupi 576104
Udupi
KARNATAKA |
9920447467
aishwaryaharidas9493@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E038||Other specified hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Solitary thyroid nodule
Unilateral goitre
Thyroid cyst
Follicular nodule
Nodules with indeterminate characteristics on fine needle aspiration cytology |
|
| ExclusionCriteria |
| Details |
Past history of thyroid or neck surgery
History of thyroid malignancy, radiotherapy, immunotherapy, chemotherapy, Grave’s disease, thyroid Otis, radioactive iodine
Preoperative elevation in serum TSH (subclinical or clinical hypothyroidism)
Patients who do not consent for surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe changes in serum calcium and serum TSH, preoperatively and postoperatively after 3 weeks |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sub-analysis will be done taking into consideration factors such as patient’s age, sex etc to identify who is at a higher risk of developing subclinical or clinical postoperative hypothyroidism. |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
To be done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, by having patients undergo testing of serum calcium and serum TSH and studying the values pre-operatively and on 3-week follow up postoperatively, the intention is to study the time of onset of postoperative hypothyroidism and hypocalcemia early enough so that treatment can be initiated, to avoid morbidities associated with the two. |