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CTRI Number  CTRI/2025/08/092273 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Parathyroid identification during Total thyroidectomy  
Scientific Title of Study   Intraoperative parathyroid gland identification during indocyanine (ICG)guided total thyroidectomy versus conventional total thyroidectomy:A Randomised controlled study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chetna Kumari Meena 
Designation  Post Graduate 
Affiliation  Maulana Azad Medical College  
Address  Department of General Surgery Maulana Azad Medical College and associated hospital, New Delhi

Central
DELHI
110002
India 
Phone  8826050987  
Fax    
Email  drckm8826@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandar Bhushan Singh 
Designation  Director professor  
Affiliation  Maulana Azad Medical College  
Address  Department of General Surgery Maulana Azad Medical College,New Delhi

Central
DELHI
110002
India 
Phone  9717212602  
Fax    
Email  drchandrabhushansingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandar Bhushan Singh 
Designation  Director professor  
Affiliation  Maulana Azad Medical College  
Address  Department of General Surgery Maulana Azad Medical College,New Delhi

Central
DELHI
110002
India 
Phone  9717212602  
Fax    
Email  drchandrabhushansingh@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College New Delhi 110002 India 
 
Primary Sponsor  
Name  Maulana Azad Medical College  
Address  Maulana Azad Medical College and associated hospital bahadur shah Zafar Marg New Delhi 110002 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chetna Kumari Meena  Lok Nayak Hospital  Maulana Azad Medical College And Associated Hospital,General surgery
Central
DELHI 		 8826050987

drckm8826@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAULANA AZAD MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient between age of 18-65years of any gender presenting to Lok Nayak Hospital and planned for total thyroidectomies. 
 
ExclusionCriteria 
Details  Previous neck surgery.
Any known allergies.
Pregnanacy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Identification of parathyroid gland during total thyroidectomy  post operative day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Change in serum parathormone & calcium level at day 1 postoperatively.  24 hours 
Duration of surgery from incision till closure in min   
Duration of hospital stay in days.   
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   20/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drckm8826@gmail.com].

  6. For how long will this data be available start date provided 15-05-2025 and end date provided 15-05-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   I am conducting study on Parathyroid identification intraoperatively during total thyroidectomy. The motive of this study is to reduce the hypoparathyroidism and its complication after total thyroidectomy. It includes the patient presented to surgery opd between 18-65 yrs.In this study I will randomly categorize patients in two groups using computer generated random numbers, in one group patients will be undergoing Indocyanine green (ICG)  guided Thyroidectomy and in other group patients will be undergoing conventional thyroidectomy. In both groups after thyroid removal number of parathyroid glands will be identified using ICG. Postoperatively after 24hrs patient’s parathyroid and calcium level will be assessed. 
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