| CTRI Number |
CTRI/2025/10/096306 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective analytical study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect Of optimisation of preoperative hypocalcemia on incidence and effects of post operative hypocalcemia in patients undergoing total thyroidectomy |
|
Scientific Title of Study
|
Effect of prehabilitation on post-operative hypocalcemia in patients undergoing total thyroidectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
E Madhuri |
| Designation |
Junior Resident |
| Affiliation |
Jawaharal Nehru Medical College |
| Address |
Dept. of General Surgery,
4th floor, SMSC building, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9491687751 |
| Fax |
|
| Email |
emadhuyadav504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Ghanshyam Deshpande |
| Designation |
Associate Professor General Surgery |
| Affiliation |
Jawaharal Nehru Medical College |
| Address |
Dept. of General Surgery,
4th floor, SMSC building, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9969274572 |
| Fax |
|
| Email |
dswat86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Ghanshyam Deshpande |
| Designation |
Associate Professor General Surgery |
| Affiliation |
Jawaharal Nehru Medical College |
| Address |
Dept. of General Surgery,
4th floor, SMSC building, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9969274572 |
| Fax |
|
| Email |
dswat86@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Rsearch |
| Address |
Sawangi Meghe, Wardha, maharashtra -442001 |
| Type of Sponsor |
Private medical college |
|
|
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 E Madhuri |
ACHARYA VINOBA BHAVE RURAL HOSPITAL |
ACHARYA VINOBA BHAVE RURAL HOSPITAL , JAWAHARALAL NEHRU MEDICAL COLLEGE . DEPARTEMENT OF GENERAL SURGERY , DMIHER, SAWANGI MEGHE, WARDHGA. MAHARASTRA , WARDHA .
Wardha
MAHARASHTRA |
9491687751
emadhuyadav504@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: E898||Other postprocedural endocrine andmetabolic complications and disorders, |
|
|
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 |
Ages between 18 to 65 years who will be planned for total thyroidectomy.
All genders
Patients with ASA grade1 and 2
All individuals who are consenting for study |
|
| ExclusionCriteria |
| Details |
Patients who will be lost for follow up .
Patients with hypoparathyroidism, renal failure, drugs, ( bicarbonate, rifampicin), hypomagnesemia, acute pancreatitis.
Patients who are not consenting. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help to evaluate the role of pre operative correction ( pre habilitation) of hypocalcemia and hypovitaminosis D in preventing post op hypocalcemia in pts undergoing total thyroidectomy. It will also help us to evaluate the role of early operative levels of serum parathormone levels to predict post operative hypocalcemia/hypoparathyroidism and risk of protracted hypocalcemia. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate hypocalcemia in pts undergoing total thyroidectomy |
2 years |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
02/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is a prospective observational study which aims to assess the demographic profile and indications for total thyroidectomy. To estimate the incidence of preoperative hypocalcaemia and hypovitaminosis D3 in patients posted for total thyroidectomy and to correct them preoperatively. To evaluate the intra operative findings in terms of whether parathyroid glands are identified at surgery, superior or inferior or both glands are identified, site of ligation of inferior thryoid artery , whether auto transplatation of parathyroid glands is done during surgery.To estimate te incidence of post operative hypothyroidism 24 hours after surgery by Serum iPTH levels. To estimate the incidence of clinical and biochemical hypocalcemia on Day 1 and Day 3 post surgery. Hypocalcemia is life threatening situation , many patients preoperatively have hypocalcemia and hypo -vitaminosis D , so we try to evaluate pre operative calcium levels with early post operative parathormone level and serum calcium to reduce the risk of post operative hypocalcemia which might lead to permanent hypothyroidism.
This study will help to evaluate the role of pre-operative correction ( prehabiliatation) of hypcalcemia and hypovitaminosis d in preventing post op hypocalcemia in patients undergoing total thyroidectomy.It will also help us evaluate the role of early operative levels of serum parathormone levels to predict post operative hypocalcemia / hypoparathyroidism and risk of protracted hypocalcemia.
|