ASSESSMENT OF VOICE QUALITY IN PATIENTS UNDERGOING MICROLARYNGEAL SURGERY FOR BENIGN VOCAL CORD LESIONS USING COBLATION VERSUS CONVENTIONAL METHOD
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
BALAJI D
Bangalore Medical College and Research Institute