| CTRI Number |
CTRI/2025/05/086172 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Comparing Voice Improvement After Throat Surgery Using Coblation or Conventional Methods in Patients with Non-Cancerous Vocal Cord Growths" |
|
Scientific Title of Study
|
ASSESSMENT OF VOICE QUALITY IN PATIENTS UNDERGOING MICROLARYNGEAL SURGERY FOR BENIGN VOCAL CORD LESIONS USING COBLATION VERSUS CONVENTIONAL METHOD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BALAJI D |
| Designation |
Post Graduate |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
ENT Department, Victoria Hospital
City Market, New Tharagupet, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
7795889831 |
| Fax |
|
| Email |
dbalajidoc98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KARTHIK S |
| Designation |
MBBS MS ENT MRCS |
| Affiliation |
City Market, New Tharagupet, Bengaluru |
| Address |
ENT Department, Victoria Hospital
City Market, New Tharagupet, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9845132428 |
| Fax |
|
| Email |
dr_karthik_s@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KARTHIK S |
| Designation |
MBBS MS ENT MRCS |
| Affiliation |
City Market, New Tharagupet, Bengaluru |
| Address |
ENT Department, Victoria Hospital
City Market, New Tharagupet, Bengaluru
KARNATAKA
560002
India |
| Phone |
9845132428 |
| Fax |
|
| Email |
dr_karthik_s@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college |
|
|
Primary Sponsor
|
| Name |
BALAJI D |
| Address |
ENT Department, Victoria Hospital
City Market, New Tharagupet, Bengaluru, |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| BALAJI D |
Victoria Hospital, BMCRI |
ENT department, Major OT,Room no 113
Bangalore
KARNATAKA |
7795889831
dbalajidoc98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ENT Department, Victoria Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J381||Polyp of vocal cord and larynx, (2) ICD-10 Condition: J382||Nodules of vocal cords, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MICRLARYNGEAL SURGERY
COBLATION TECHNIQUE |
A newer technique that uses low-temperature radiofrequency energy (Coblation) to remove lesions with minimal tissue damage. It is thought to potentially result in better voice outcomes and faster healing |
| Intervention |
MICROLARYMGEAL SURGERY
CONVENTIONAL TECHNIQUE USING SCISSORS |
Standard microlaryngeal surgery for benign vocal cord lesions using traditional instruments (such as cold steel tools or lasers). This method has been widely used but may involve more thermal or mechanical trauma. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
ENT outpatient department with complaints of hoarseness of voice and on videolaryngoscopy were found to have benign appearing vocal cord lesions. |
|
| ExclusionCriteria |
| Details |
1. Malignant lesions
2. Vocal cord paralysis
3. Patients with severe cervical spondylosis.
4. Patients not willing to give informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. GRBAS SCORE - Grade, Roughness, Breathiness, Asthenia, Strain and Voice
handicap index 10
2. Jitter and shimmer in prat software.
3. Visual analogue score |
one week and 4 weeks after sugery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Jitter and shimmer in prat software.
3. Visual analogue score |
one week and 4 weeks after sugery |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/05/2025 |
| 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 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
|
After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent. (Annexure – 1A / 1B/ 1C)
Baseline investigations such as blood sugar levels, complete blood count, renal and liver function tests, HIV, HBsAg, HCV, will be done.
Patients will be screened by videolaryngoscopy under local anaesthesia to find out the pathology. Patients will be explained about the disease, the probable cause and its line of management.
Preoperative voice assessment will be done using GRBAS scoring and voice handicap index and PRAT software.
Patient will be randomized into two groups A and B based on random sequence generated by Statical Package for Social Sciences software, where Group A will include patients undergoing microlaryngeal surgery by conventional method and Group B will include patients undergoing microlaryngeal excision using coblation.
Patients will be followed up postoperatively at an interval of 1 week and 1month for voice assessment |