| CTRI Number |
CTRI/2021/05/033322 [Registered on: 03/05/2021] Trial Registered Prospectively |
| Last Modified On: |
01/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To identify predictors of post operative decrease in calcium in patients undergoing thyroid surgery |
|
Scientific Title of Study
|
Predictors of post operative hypocalcemia in patients undergoing thyroidectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JIBIN C J |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of medical Science, Jodhpur |
| Address |
OPD Block 4th floor Department Of Otorhinolaryngology AIIMS Jodhpur Jodhpur
India
OPD Block 4th floor Department Of Otorhinolaryngology AIIMS Jodhpur Jodhpur
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9562115689 |
| Fax |
|
| Email |
jibincj20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KAPIL SONI |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of medical Science, Jodhpur |
| Address |
OPD Block 4th floor Department Of Otorhinolaryngology AIIMS Jodhpur Jodhpur
India
OPD Block 4th floor Department Of Otorhinolaryngology AIIMS Jodhpur Jodhpur
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003898485 |
| Fax |
|
| Email |
ksoni805@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KAPIL SONI |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of medical Science, Jodhpur |
| Address |
OPD Block 4th floor Department Of Otorhinolaryngology AIIMS Jodhpur Jodhpur
India
OPD Block 4th floor Department Of Otorhinolaryngology AIIMS Jodhpur Jodhpur
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003898485 |
| Fax |
|
| Email |
ksoni805@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Jodhpur |
| Address |
All India Institute Of Medical Sciences Jodhpur Basni Industrial area MIA 2nd phase Basni Jodhpur Rajasthan 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr JIBIN C J |
All India Institute Of Medical Sciences Jodhpur |
Department of Otorhinolaryngology Room no 405 block A 4th floor Basni Industrial Area MIA 2nd phase Basni Jodhpur Rajasthan 342005
Jodhpur
RAJASTHAN |
9562115689
jibincj20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E049||Nontoxic goiter, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Any patient undergoing thyroid surgery in Department Of Otorhinolaryngology AIIMS Jodhpur |
|
| ExclusionCriteria |
| Details |
Patients with concomitant primary hyperparathyroidism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the predictors of post operative hypocalcemia in thyroidectomy patients |
one and half years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify seasonal variation in post operative hypocalcemia |
one and half years |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
10/05/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It
will be a Prospective Observational Cohort study on patients
undergoing thyroidectomy in the Department of Otorhinolaryngology, AIIMS ,
Jodhpur . After
taking an informed consent , all patients will be analyzed
clinically. Preoperative
testing for serum calcium, PTH and Vit D will be done on the day of surgery. These
patients will be subjected to surgery as per preop clinic discussion. Post
operative test for serum calcium will be done on day 0 & day 1. PTH
will be measured at 24 hr post operatively. All
patients will be assessed clinically for signs & symptoms of hypocalcemia
till 48 hours post operatively and they will be correlated with the biochemical
parameters , season in which surgery was done, duration of surgery and amount
of blood loss |