Skip to main content
Clinical Trials/CTRI/2025/05/086172
CTRI/2025/05/086172Not yet recruitingNot Applicable

ASSESSMENT OF VOICE QUALITY IN PATIENTS UNDERGOING MICROLARYNGEAL SURGERY FOR BENIGN VOCAL CORD LESIONS USING COBLATION VERSUS CONVENTIONAL METHOD

BALAJI D1 site in 1 country40 target enrollmentStarted: May 20, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
1. GRBAS SCORE - Grade, Roughness, Breathiness, Asthenia, Strain and Voice

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • ENT outpatient department with complaints of hoarseness of voice and on videolaryngoscopy were found to have benign appearing vocal cord lesions.

Exclusion Criteria

  • Malignant lesions
  • Vocal cord paralysis
  • Patients with severe cervical spondylosis.
  • Patients not willing to give informed consent.

Outcomes

Primary Outcomes

1. GRBAS SCORE - Grade, Roughness, Breathiness, Asthenia, Strain and Voice

Time Frame: one week and 4 weeks after sugery

handicap index 10

Time Frame: one week and 4 weeks after sugery

2. Jitter and shimmer in prat software.

Time Frame: one week and 4 weeks after sugery

3. Visual analogue score

Time Frame: one week and 4 weeks after sugery

Secondary Outcomes

  • 2. Jitter and shimmer in prat software.(3. Visual analogue score)

Investigators

Sponsor
BALAJI D
Sponsor Class
Other [nil]
Responsible Party
Principal Investigator
Principal Investigator

BALAJI D

Bangalore Medical College and Research Institute

Study Sites (1)

Loading locations...

Similar Trials