Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Post-operative calcium and parathyroid hormone level on POD1 |
Serum calcium and parathyroid hormone level will be monitored |
Post-op 1 day |
|
Primary |
Post-operative calcium and parathyroid hormone level after 3 months post-op |
Serum calcium and parathyroid hormone level will be monitored |
Post-op 3 months |
|
Primary |
Post-operative calcium and parathyroid hormone level after 6 months post-op |
Serum calcium and parathyroid hormone level will be monitored |
Post-op 6 months |
|
Primary |
Voice Handicap Index (VHI-10) |
Subjective voice assessment consisting of 10 questions. Each question 0-4 score |
Post-op 1 week |
|
Primary |
Voice Handicap Index (VHI-10) |
Subjective voice assessment consisting of 10 questions. Each question 0-4 score |
Post-op 3 months |
|
Primary |
Voice Handicap Index (VHI-10) |
Subjective voice assessment consisting of 10 questions. Each question 0-4 score |
Post-op 6 months |
|
Primary |
Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV) |
Objective voice assessment consisting of 10 questions. Each question 1-10 score. 1 being normal and 10 being the most severe voice dysfunction |
Post-op 1 week |
|
Primary |
Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV) |
Objective voice assessment consisting of 10 questions. Each question 1-10 score. 1 being normal and 10 being the most severe voice dysfunction |
Post-op 3 months |
|
Primary |
Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV) |
Objective voice assessment consisting of 10 questions. Each question 1-10 score. 1 being normal and 10 being the most severe voice dysfunction |
Post-op 6 months |
|
Primary |
Acoustic Evaluation |
Instruct patient to sustain vowel /a/ and to read aloud the Hong Kong passage at a comfortable pitch and loudness level for about 3-5 seconds. Keep a distance of 15cm from the microphone for recording. Highlight the middle 3 seconds for analysis. To assess the fundamental frequency (Hz) and performance (dB) |
Post-op 1 week |
|
Primary |
Acoustic Evaluation |
Instruct patient to sustain vowel /a/ and to read aloud the Hong Kong passage at a comfortable pitch and loudness level for about 3-5 seconds. Keep a distance of 15cm from the microphone for recording. Highlight the middle 3 seconds for analysis. To assess the fundamental frequency (Hz) and performance (dB) |
Post-op 3 months |
|
Primary |
Acoustic Evaluation |
Instruct patient to sustain vowel /a/ and to read aloud the Hong Kong passage at a comfortable pitch and loudness level for about 3-5 seconds. Keep a distance of 15cm from the microphone for recording. Highlight the middle 3 seconds for analysis. To assess the fundamental frequency (Hz) and performance (dB) |
Post-op 6 months |
|
Primary |
Aerodynamic Evaluation (Maximum sustained phonation) |
Instruct patient to sustain vowel /a/ at a comfortable pitch and loudness level for as long as possible after taking a deep breath. Recorded in seconds |
Post-op 1 week |
|
Primary |
Aerodynamic Evaluation (Maximum sustained phonation) |
Instruct patient to sustain vowel /a/ at a comfortable pitch and loudness level for as long as possible after taking a deep breath. Recorded in seconds |
Post-op 3 months |
|
Primary |
Aerodynamic Evaluation (Maximum sustained phonation) |
Instruct patient to sustain vowel /a/ at a comfortable pitch and loudness level for as long as possible after taking a deep breath. Recorded in seconds |
Post-op 6 months |
|
Secondary |
Calcium and Rocaltrol requirement |
The required dosage of Calcium Carbonate and Rocaltrol will be documented |
Post-op 1 week |
|
Secondary |
Calcium and Rocaltrol requirement |
The required dosage of Calcium Carbonate and Rocaltrol will be documented |
Post-op 3 months |
|
Secondary |
Calcium and Rocaltrol requirement |
The required dosage of Calcium Carbonate and Rocaltrol will be documented |
Post-op 6 months |
|
Secondary |
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Number of participants experiencing side effects from Dexamethasone will be documented |
Post-op 1 week |
|
Secondary |
Stroboscopic Assessment (Vocal Fold Edge) |
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular) |
Post-op 1 week |
|
Secondary |
Stroboscopic Assessment (Vocal Fold Edge) |
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular) |
Post-op 3 months |
|
Secondary |
Stroboscopic Assessment (Vocal Fold Edge) |
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular) |
Post-op 6 months |
|
Secondary |
Stroboscopic Assessment (Glottic Closure) |
Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete) |
Post-op 1 week |
|
Secondary |
Stroboscopic Assessment (Glottic Closure) |
Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete) |
Post-op 3 months |
|
Secondary |
Stroboscopic Assessment (Glottic Closure) |
Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete) |
Post-op 6 months |
|
Secondary |
Stroboscopic Assessment (Vertical Level of Approximation) |
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable |
Post-op 1 week |
|
Secondary |
Stroboscopic Assessment (Vertical Level of Approximation) |
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable |
Post-op 3 months |
|
Secondary |
Stroboscopic Assessment (Vertical Level of Approximation) |
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable |
Post-op 6 months |
|
Secondary |
Stroboscopic Assessment (Amplitude) |
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement |
Post-op 1 week |
|
Secondary |
Stroboscopic Assessment (Amplitude) |
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement |
Post-op 3 months |
|
Secondary |
Stroboscopic Assessment (Amplitude) |
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement |
Post-op 6 months |
|
Secondary |
Stroboscopic Assessment (Mucosal wave) |
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent |
Post-op 1 week |
|
Secondary |
Stroboscopic Assessment (Mucosal wave) |
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent |
Post-op 3 months |
|
Secondary |
Stroboscopic Assessment (Mucosal wave) |
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent |
Post-op 6 months |
|
Secondary |
Stroboscopic Assessment (Regularity) |
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular |
Post-op 1 week |
|
Secondary |
Stroboscopic Assessment (Regularity) |
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular |
Post-op 3 months |
|
Secondary |
Stroboscopic Assessment (Regularity) |
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular |
Post-op 6 months |
|
Secondary |
Stroboscopic Assessment (Ventricular folds) |
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress |
Post-op 1 week |
|
Secondary |
Stroboscopic Assessment (Ventricular folds) |
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress |
Post-op 3 months |
|
Secondary |
Stroboscopic Assessment (Ventricular folds) |
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress |
Post-op 6 months |
|