| CTRI Number |
CTRI/2025/12/099464 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Thyroid Surgery With Nerve Monitoring Versus Conventional Surgery for Prevention of Voice Nerve Injury |
|
Scientific Title of Study
|
Intraoperative Nerve Monitoring (IONM) with Visual Identification versus Visual Identification Alone in Thyroid Surgery
A Randomized Controlled Trial |
| 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 Tridib Kumar Amat |
| Designation |
Junior Resident |
| Affiliation |
AIIMS ,Nagpur |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur MAHARASHTRA 441108 India
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9938284951 |
| Fax |
|
| Email |
tridibkumaramat7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashwant Lamture |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences ,Nagpur |
| Address |
Room no 206, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur MAHARASHTRA 441108 India
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9960371205 |
| Fax |
|
| Email |
yash18671@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashwant Lamture |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences ,Nagpur |
| Address |
Room no 206, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur MAHARASHTRA 441108 India
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9960371205 |
| Fax |
|
| Email |
yash18671@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur. PINCODE:441108 |
|
|
Primary Sponsor
|
| Name |
Dr Tridib Kumar Amat |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur MAHARASHTRA ,Pin code -441108,India |
| Type of Sponsor |
Other [self] |
|
|
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 Tridib Kumar Amat |
All India Institute of Medical sciences , Nagpur |
Room no 202, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA |
9938284951
tridibkumaramat7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Department of Pharmacology, AIIMS Nagpur |
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 |
| Intervention |
Intraoperative Nerve Monitoring (IONM) with Visual Identification in thyroid surgery |
Intraoperative Nerve Monitoring (IONM) with Visual Identification in thyroid surgery to look for rate of recurrent laryngeal nerve (RLN) injury, postoperative nerve function, and overall surgical outcomes .The total duration of the intervetion will be from day of surgery till 3 month of post operative period . |
| Comparator Agent |
Visual Identification Alone in Thyroid Surgery |
Visual identification alone in Thyroid Surgery to look for rate of recurrent laryngeal nerve (RLN) injury, postoperative nerve function, and overall surgical outcomes.The total duration of the intervetion will be from day of surgery till 3 month of post operative period . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 18 years undergoing thyroid surgery.
Patients with benign or malignant thyroid disease.
Patients who provide written informed consent.
Preoperative normal vocal cord function as assessed by indirect laryngoscopy
|
|
| ExclusionCriteria |
| Details |
Previous thyroid or neck surgery (revision thyroidectomy).
Preoperative vocal cord palsy.
History of neck radiation.
Known allergy to anaesthetic agents used during nerve monitoring.
Severe comorbidities making general anaesthesia unsafe.
Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine and compare the incidence of recurrent laryngeal nerve (RLN) injury in thyroid surgery using intraoperative nerve monitoring (IONM) with visual identification versus visual identification alone. |
It will be acessed immediate postoperatively ,then at 1 and 3 rd month by doing indirect layngoscope . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time taken to identify the RLN in both groups.
To assess postoperative vocal cord function.
To estimate overall operative time & postoperative complication rates.
To evaluate the cost-effectiveness of intraoperative nerve monitoring (IONM) compared to visual identification in terms of surgical outcomes, complication rates, & healthcare resource utilization
|
Length of hospital stay
Post operative complication will be checked during hospital stay. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
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
|
This research is a prospective randomized controlled trial that evaluates two approaches to thyroid surgery: the use of intraoperative nerve monitoring (IONM) along with visual identification versus visual identification alone. The study aims primarily to determine whether incorporating IONM lowers the likelihood of recurrent laryngeal nerve (RLN) injury. It also assesses additional outcomes such as the duration required to locate the RLN, postoperative vocal cord function, total operative time, and the occurrence of postoperative complications. |