| CTRI Number |
CTRI/2026/01/100420 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing laser surgery and traditional surgery for treating non-cancerous vocal fold growths |
|
Scientific Title of Study
|
Surgical treatment of benign vocal fold lesions- CO2 laser versus cold steel- a comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srijata Mandal |
| Designation |
Post graduate trainee |
| Affiliation |
Department of ENT IPGMER and SSKM Hospital |
| Address |
Department of ENT
IPGME and R and SSKMH
244 AJC Bose Road
Bhawanipur
Kolkata
West Bengal
700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
7908923150 |
| Fax |
|
| Email |
www.srijata@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arunabha Sengupta |
| Designation |
Professor |
| Affiliation |
Department of ENT IPGMER and SSKM Hospital |
| Address |
Department of ENT
IPGME and R and SSKMH
244 AJC Bose Road
Bhawanipur
Kolkata
West Bengal
700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831089737 |
| Fax |
|
| Email |
arunabhasengupta2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srijata Mandal |
| Designation |
Post graduate trainee |
| Affiliation |
Department of ENT IPGMER and SSKM Hospital |
| Address |
Department of ENT
IPGME and R and SSKMH
244 AJC Bose Road
Bhawanipur
Kolkata
West Bengal
700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
7908923150 |
| Fax |
|
| Email |
www.srijata@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital
244 AJC Bose road
Kolkata
700020
West bengal
India |
|
|
Primary Sponsor
|
| Name |
Dr Arunabha Sengupta |
| Address |
Department of ENT
IPGMER and SSKM Hospital
244 AJC Bose road
Kolkata
|
| Type of Sponsor |
Other [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 Srijata Mandal |
IPGMER and SSKM Hospital |
Room no 4 ,ENT OPD, Department of ENT
IPGME and R and SSKM Hospital
244 AJC Bose Road
Bhawanipur
Kolkata
West Bengal
700020
India
Kolkata
WEST BENGAL |
7908923150
www.srijata@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J38||Diseases of vocal cords and larynx, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold Steel Method |
In this surgery we use cold steel instruments for fine dissection of benign lesions of vocal fold with the help of laryngoscope and microscope
Time taken is 1 to 2 hours
|
| Comparator Agent |
LASER |
In this surgery we use laser instruments for fine dissection of benign lesions of vocal fold with the help of laryngoscope and microscope
Time taken is 1 to 2 hours
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Pateints belonging to either sex aged 18 years or more.
2. Patients diagnosed to be suffering from benign vocal cord lesions irrespective of duration of symptoms
3. Patients without any systemic debility
4. All patients must be willing to take part in the study through written informed consent
5. No other co-existent laryngeal pathology. |
|
| ExclusionCriteria |
| Details |
1. Any person less than 18 years of age.
2. Patients with suspected malignant tumors of vocal cord
3. Patients with any co-existing comorbidity of ear, nose or throat
4. Patients with any debilitating systemic disease
5. Revision cases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of outcomes of Cold steel versus laser microlaryngeal surgery |
3 weeks
6 weeks
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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
|
Benign vocal fold lesions are of various types and can be managed surgically either by cold steel method or by LASER with the help of microscope and laryngoscope Since LASER provides almost bloodless field its use has opened new domain in managing benign vocal fold lesions A large number of patients presents with history of hoarseness in ENT OPD and we are studying different surgical management techniques to compare outcome between these in post operative period three six twelve weeks |