| CTRI Number |
CTRI/2025/06/089405 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| 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
|
Protocol for Randomized Controlled Trial Comparing Long-Term Health-Related Quality of Life (HRQoL) Between Endoscopic Thyroidectomy (ETx) and Open Thyroidectomy (OTx) Using ThyPRO-39 Questionnaire |
|
Scientific Title of Study
|
Comparison of Long-Term Health-Related Quality of Life Between Endoscopic and Open Thyroidectomy for benign thyroid nodules: A Randomized Controlled Trial Using ThyPRO-39 Questionnaire (ELEVATE Trial: Endoscopic vs. Open Thyroidectomy Long-Term HEalth-Related QuALity of Life Using ThyPRO-39) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Kumar Yadav |
| Designation |
Assistant Professor |
| Affiliation |
NSCB Medical College Jabalpur MP |
| Address |
Department of General Surgery
NSCB Medical College Jabalpur MP
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8127095090 |
| Fax |
|
| Email |
sky1508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan Agarwal |
| Designation |
Professor |
| Affiliation |
NSCB Medical College Jabalpur MP |
| Address |
Department of General Surgery
NSCB Medical College Jabalpur MP
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
|
| Fax |
|
| Email |
drpawanagarwal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kumar Yadav |
| Designation |
Assistant Professor |
| Affiliation |
NSCB Medical College Jabalpur MP |
| Address |
Department of General Surgery
NSCB Medical College Jabalpur MP
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
8127095090 |
| Fax |
|
| Email |
sky1508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multi Disciplinary Research Unit NSCB Medical College Jabalpur MP, India-482003 |
|
|
Primary Sponsor
|
| Name |
Netaji Subhash Chandra Bose Medical College Jabalpur |
| Address |
NSCB Medical College Jabalpur MP
Tilwara Road Jabalpur MP 482003 |
| Type of Sponsor |
Government 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 Sanjay K Yadav |
NSCBMC |
Department of Surgery, Third Floor
Jabalpur
MADHYA PRADESH |
8127095090
sky1508@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Netaji Subhash Chandra Bose Medical College Jabalpur MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E079||Disorder of thyroid, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open thyroid surgery |
Patients in this group will undergo open thyroid surgery without using endoscope |
| Intervention |
Transoral endoscopic thyroidectomy |
Patient in this group will undergo endoscopic thyroid surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Indication for thyroidectomy: benign nodules
No prior thyroid or neck surgery.
|
|
| ExclusionCriteria |
| Details |
- Contraindications for general anesthesia.
- Thyroid malignancy
- Incomplete follow-up at 12 months post-surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The trial is expected to clarify the long-term HRQoL differences between ETx and OTx, providing evidence for selecting surgical techniques based on patient-centered outcomes
HRQoL at 12 months post-surgery assessed by ThyPRO-39.
Rates of hypoparathyroidism, RLN palsy |
Baseline, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rates of hypoparathyroidism, RLN palsy |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
05/07/2025 |
| 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 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
|
This randomized controlled trial compares the long term health related quality of life HRQoL between endoscopic thyroidectomy ETx and open thyroidectomy OTx for benign thyroid nodules using the ThyPRO 39 questionnaire The primary outcome is HRQoL at 12 months post surgery with secondary outcomes including long term surgical outcomes and complication rates The study aims to provide high quality evidence to inform the choice of surgical technique based on patient centered outcomes A total of 106 participants will be enrolled and randomized to either ETx or OTx group The study’s findings are expected to clarify the long term HRQoL differences between ETx and OTx providing evidence for selecting surgical techniques based on patient centered outcomes. |