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CTRI Number  CTRI/2026/01/101570 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On: 16/01/2026
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   Comparison two methods of parathyroid auto transplantation during total thyroidectomy in reducing rate of permanent hypoparathyroidism post thyroidectomy 
Scientific Title of Study   The role of selective versus routine parathyroid auto transplantation during total thyroidectomy in reducing rate of permanent hypoparathyroidism 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swarna Azaria 
Designation  MCH senior post graduate registrar 
Affiliation  Christian medical college, Vellore 
Address  Endocrine surgery office, Paul Brand building, CMC Vellore
Directorate CMC Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9945941150  
Fax    
Email  swarna.azaria@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  anish jacob cherian 
Designation  professor 
Affiliation  Christian medical college, Vellore 
Address  Endocrine surgery office, Paul Brand building, Christian medical college, Vellore
Directorate Christian medical college, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9840427637  
Fax    
Email  anish@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  anish jacob cherian 
Designation  professor 
Affiliation  Christian medical college, Vellore 
Address  Endocrine surgery office, Paul Brand building, Christian medical college, Vellore
Directorate Christian medical college, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9840427637  
Fax    
Email  anish@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Christian medical college, Vellore 
 
Primary Sponsor  
Name  Christian medical college Vellore 
Address  Christian medical college, Vellore Tamil nadu 632004 India 
Type of Sponsor  Research institution and hospital 
 
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 Swarna Azaria  Christian medical college, Vellore  Department of Endocrine surgery,Christian medical college, Vellore 632004, Tamil Nadu
Vellore
TAMIL NADU 
9945941150

swarna.azaria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD(IRB) CHRISTIAN MEDICAL COLLEGE, VELLORE, INDIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: E368||Other intraoperative complicationsof endocrine system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Routine parathyroid auto transplantation  Routine re implantation of at least one parathyroid gland, even when the vascularity is unaltered. 
Comparator Agent  Selective parathyroid auto transplantation  When the parathyroid gland is inadvertently removed, found on the specimen, or found to have no anatomical capacity for preservation of the parathyroid in situ, or devascularized - only then it is auto transplanted 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients admitted for a total thyroidectomy with or without a neck dissection and patients undergoing completion thyroidectomy 
 
ExclusionCriteria 
Details  Patients undergoing hemi thyroidectomy 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of type of parathyroid auto transplantation in reducing the
rate of post-thyroidectomy permanent hypoparathyroidism at 6 months. 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
a) To analyze the incidence of permanent hypoparathyroidism at 6 months.
b) To compare the rates of post operative temporary
hypoparathyroidism between routine & selective parathyroid auto
transplantation groups at 6 months. 
6 months 
 
Target Sample Size   Total Sample Size="580"
Sample Size from India="580" 
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   Phase 4 
Date of First Enrollment (India)   27/01/2026 
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="2"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  
Thyroidectomy, though a common procedure performed world over, can result in life changing
complications such as post-operative hypoparathyroidism and recurrent laryngeal nerve palsy.
Post-operative hypoparathyroidism is the most commonly encountered complication and is
defined as a low (below the lower limit of the labs reference range) intact PTH (parathormone)
level, following bilateral thyroid surgery.
This may be either temporary when it resolves within six months of surgery or permanent when
PTH levels persist to be low six months after surgery. The reported incidence of temporary and
permanent hypoparathyroidism is 18-39% and 0-3% respectively. The reasons for the
development of post-thyroidectomy hypoparathyroidism are multifactorial, however, the most
important cause is related to the parathyroid glands and may result from either inadvertent
injury/resection to the parathyroid gland during thyroidectomy or due to devascularization of
parathyroid glands.
The management of temporary hypoparathyroidism include oral calcium and activated vitamin
D supplementation and intravenous calcium infusion in a subset of patients. This results in
increased hospital stay and cost. Further, there is a risk of re-admissions for the management of
severe hypoparathyroidism. Permanent hypoparathyroidism on the other hand, even though less
frequent, significantly impairs quality of life. In addition, long term effects include chronic renal impairment, reduced bone remodeling, increased psychiatric complaints and basal ganglia
calcification.
Various adjuncts to aid identification and the assessment of viability of the parathyroid glands
during thyroid surgery, in order to decrease the rates of post-surgery hypoparathyroidism, have
been developed. These include parathyroid angiography with indocyanine green, parathyroid
auto fluorescence, carbon nanoparticles and gamma probe. Though these methods have
reported some benefit in decreasing temporary hypoparathyroidism rates, its effects on
permanent hypoparathyroidism have not been promising. In addition, these methods are time
consuming and expensive. A simple, inexpensive, easy alternative to the above is parathyroid
gland auto-transplantation. This involves the reimplantation of at least one parathyroid gland
during thyroid surgery into the sternocleidomastoid muscle. Reimplanted parathyroid glands
have been shown to regain function in 6-8 weeks following transplant. There are two methods
of parathyroid auto-transplantation: routine and selective. We aim to compare these two
methods to determine if there is a significant 
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