| CTRI Number |
CTRI/2023/11/059854 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
13/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of a new machine to prevent nerve injury during thyroid surgery |
|
Scientific Title of Study
|
Role of intraoperative neuromonitoring in identification of external branch of superior laryngeal nerve during thyroidectomy operation |
| 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 Sanjib Barman |
| Designation |
Post graduate trainee |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of otorhinolaryngology,Silchar Medical College and Hospital, Ghungoor, Silchar
Cachar
ASSAM
788014
India |
| Phone |
8638094036 |
| Fax |
|
| Email |
sanjibbarman0786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinandan Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of otorhinolaryngology,Silchar Medical College and Hospital, Ghungoor, Silchar
Cachar
ASSAM
788014
India |
| Phone |
9435072159 |
| Fax |
|
| Email |
dr.abhinandan1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinandan Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
Silchar Medical College and Hospital |
| Address |
Department of otorhinolaryngology,Silchar Medical College and Hospital, Ghungoor, Silchar
Cachar
ASSAM
788014
India |
| Phone |
9435072159 |
| Fax |
|
| Email |
dr.abhinandan1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Silchar Medical College and Hospital,Ghungoor,Silchar,Cachar,Assam,788014 |
|
|
Primary Sponsor
|
| Name |
Dr Sanjib Barman |
| Address |
Department of otorhinolaryngology,Silchar Medical College and Hospital, Ghungoor, Silchar,Cachar,Assam,pin-788014 |
| 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 Sanjib Barman |
Silchar Medical College and Hospital |
Department of otorhinolaryngology
Cachar
ASSAM |
8638094036
sanjibbarman0786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Silchar Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D34||Benign neoplasm of thyroid gland, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraoperative Neuromonitoring |
IONM is performed using the nerve integrity monitor (NIM-Response 3.0 System; Medtronic Xomed, Jacksonville, FL, USA) . The device is configured with an amplitude threshold of 100 µV and a stimulation intensity of 1mA. Surface electrodes integrated with an endotracheal tube with a 7.0 or 8.0mm I.D. (NIM®EMG standard reinforced endotracheal tube; Medtronic Xomed, Jacksonville, FL, USA) are attached to the nerve integrity monitor. During intubation, the tube is placed between VCs under direct vision. A monopolar electrode with an interrupted stimulation approach is used to activate the nerve at a frequency of 4 Hz, a period of 100 ms, and a current of 1 mA. A distinct EMG-evoked action potential waveform 100 uV is acquired. A positive signal is identified by detecting contraction of the cricothyroid muscle ( "cricothyroid twitch") and/or a formal glottic response acoustic alert. The amplitudes of responses are recorded. |
| Comparator Agent |
Standard visual identification |
Nerve is identified by direct visual observation during operation without the help of intraoperative neuromonitoring. Approximate duration of surgery is 2 hours though it depends upon the surgeon |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All patients within the age group between 20 and 50 years with thyroid swellings, nodular or cystic, benign or malignant, subjected to thyroidectomy will be included in the study |
|
| ExclusionCriteria |
| Details |
1.Previous thyroid surgery or other surgery involving neck
2.Previous history of radiation to neck
3.Anaplastic carcinoma of thyroid
4.Patients with any preoperative vocal cord mobility disorder
5.Pregnancy and lactation
6.Bleeding diathesis, anemia, poor anesthetic risk or uncontrolled medical illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of intraoperative neuromonitoring in identification of external branch of superior laryngeal nerve during thyroidectomy operation in comparison to the standard visual identification |
During operation, post operative day 1,5 and 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess pitfalls in the use of nerve monitor during external branch of superior laryngeal nerve identification in thyroidectomy operation. |
During operation |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/11/2023 |
| 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="0"
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
|
Thyroidectomy is a common operation performed in otorhinolaryngology. The presence of nodules or tumours on the thyroid gland is the most common reason for thyroid surgery. Nodules can either be benign or malignant. The recurrent laryngeal nerve (RLN) and external branch of superior laryngeal nerve (EBSLN) are the main structures that must be preserved in thyroid surgery to prevent postoperative voice deterioration. One of the most difficult aspects of thyroid surgery is preventing Injury to the external branch of superior laryngeal nerve. EBSLN damage rates have been reported to range from 0 to 58%, depending on different postoperative assessment methods. The EBSLN innervates the cricothyroid muscle (CTM), whose primary function is to raise the tension of the adducted ipsilateral vocal folds during elevation of pitch. Clinical symptoms primarily include: vocal fatigue, reduced vocal frequency range, particularly with regard to raising pitch which may lead to decreased quality of life, especially for those voice professionals. Even in those who are not singers, the injury could result in objective voice quality changes. However EBSLN has received minimal attention, for which Delbridge declared it as the "Neglected nerve in thyroid surgery". Careful anatomic identification during dissection can help prevent injury to the EBSLN during thyroid surgery. Intraoperative neuromonitoring (IONM) has been suggested as an addition to the standard visual identification of both the recurrent laryngeal nerve (RLN) and EBSLN during thyroid surgery, in an effort to aid in the visualisation of and hence reduce the incidence of EBSLN injury during thyroidectomy operation. This study is the first study from our institute whereby we will evaluate the contribution of intraoperative neuromonitoring in identification and preservation of external branch of superior laryngeal nerve during thyroidectomy operation and assess any difficulties and pitfalls during the use of the nerve monitor in such cases. |