Vocal Cord CystNCT06703515
Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Vocal Cord Cyst
A study testing Awake transnasal laser-assisted surgery (TNLS) and Microlaryngeal surgery (MLS) in people with Vocal Cord Cyst, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective randomised controlled trial conducted at two tertiary referral hospitals in Hong Kong to compare the clinical and functional outcomes of office-based awake transnasal laser-assisted laryngeal surgery (TNLS) under local anesthesia to traditional microlaryngeal surgery for vocal cord cyst under… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocal Cord Cyst
- What is being tested?
- Awake transnasal laser-assisted surgery (TNLS) and Microlaryngeal surgery (MLS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with vocal cord cysts
- older than 18-year-old
- able to independently provide consent
- able to tolerate flexible laryngoscopy would be recruited
Who cannot join
- under 18-year-old
- unable to independently give an informed consent
- unable to tolerate flexible laryngoscopy
- allergic to local anesthesia
- had unfavorable anatomy such as prolapsing epiglottis precluding adequate visualization, extensive lesions and an expected difficult operation as judged by the surgeons
- with pathologies other than vocal cord cyst
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The Chinese University of Hong Kong
Hong Kong
Wing Kei Ng, +852 35051409, cherrieng@cuhk.edu.hk
About this study
Official title: Randomized Controlled Trial of Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Vocal Cord Cyst
This is a prospective randomised controlled trial conducted at two tertiary referral hospitals in Hong Kong to compare the clinical and functional outcomes of office-based awake transnasal laser-assisted laryngeal surgery (TNLS) under local anesthesia to traditional microlaryngeal surgery for vocal cord cyst under general anesthesia.
Read the detailed description
The aim of the study is to prospectively compare the functional and clinical outcomes of TNLS under local anesthesia and MLS under general anesthesia in managing vocal cord cysts.
Office-based awake transnasal laser-assisted surgery (TNLS) has been gaining popularity in treating different laryngeal lesions, with the advantages of avoiding general anesthetic risks and minimizing healthcare-related costs. In addition, the general waiting time for surgeries under general anesthesia in public hospitals is getting longer due to the increasing population and limited resources. The investigators have recently conducted a novel randomized controlled trial in 2021-2022 comparing the functional and cost-effectiveness of traditional microlaryngeal surgery (MLS) under general anesthesia and TNLS for benign laryngeal lesions (vocal cord polyps, nodules, cysts, granuloma and Reinke's edema), and found that TNLS was superior to MLS in terms of length of stay, intraoperative complications, perioperative throat discomfort and hospital costs; while it was equivalent to MLS in terms of functional outcome, operative time and recurrence rate. However, since the previous study's main goal was to compare TNLS to MLS in a macroscopic perspective in terms of functional outcomes and cost-effectiveness, it had included a wide variety of benign laryngeal lesions, and different vocal cord lesions may respond differently to laser surgery.
Vocal cord cyst is a fluid-filled sac inside the vocal cord, with 2 subtypes: 1) Epidermoid cyst due to epithelial inclusion 2) Mucous retention cyst due to glandular ductal obstruction. Vocal cord cysts typically do not resolve with voice therapy, and are traditionally excised with microlaryngeal surgery with microflap technique or marsupialization. In our previous RCT study, subgroup analysis did not show a significant difference of vocal cord cyst recurrence in both TNLS and MLS group. However, the investigators' cohort had a higher overall vocal cord cyst recurrence rate (13.8%) compared to historic cohort rate of 2.2-8.7% , which may be accounted by that the vocal cord cysts were ablated and marsupialized instead of removed in the TNLS group. Nevertheless, a recent case series by Gao and colleagues showed a good functional outcome of awake KTP-laser marsupialization in selected cases. A larger cohort is warranted to compare TNLS to MLS for vocal cord cyst. Therefore, the investigators would like to conduct a randomized controlled trial to compared tradition MLS surgery to TNLS, with hypothesis that TNLS would be non-inferior to traditional microlaryngeal surgery in benign laryngeal lesions, and with its additional benefits on minimization of anesthetic risks and hospital expenses, hopefully to expand its further application.
- Conditions
- Vocal Cord Cyst
- Being tested
- Awake transnasal laser-assisted surgery (TNLS), Microlaryngeal surgery (MLS)
- Keywords
- Vocal cord cyst, Transnasal laser surgery, Microlaryngeal surgery, Office based laser surgery, Awake laser laryngeal surgery, Trublue laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake transnasal laser-assisted surgery (TNLS)Procedure or surgery
For TNLS, patients are admitted to the day center on the same morning or afternoon of the surgery with fasting prior 6 hours. After local anesthesia application, a 445nm blue laser is introduced via a working channel of bronchoscope and laser ablation of vocal cord cyst is performed. During the operation, patient will receive continuous SpO2 monitoring with regular blood pressure monitoring. After the procedure, patients are kept nil-by-mouth for 2 hours until anesthesia wears off, meanwhile with close observation in day ward with continuous SpO2 monitor for 1 hour. Patients will be discharged on the same day of the procedure, with voice rest for 3 days.
Microlaryngeal surgery (MLS)Procedure or surgery
For traditional MLS under general anesthesia, after general anesthesia and intubation with microlaryngeal tube, the patient would be positioned on head-ring support for better alignment and access to glottis. A laryngoscope will be inserted transorally under direct vision and suspended. Vocal cord cysts are visualized with microscope, and removed with microsurgery instruments with microflap technique and sent for routine section. After the surgery, the patient is kept nil-by-mouth until fully awake, and is discharged on same day or the next day depending on the post- operative recovery. Patient will be discharged with voice rest for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Microlaryngeal surgery (MLS) | Active comparator | For traditional MLS under general anesthesia, after general anesthesia and intubation with microlaryngeal tube, the patient would be positioned on head-ring support for better alignment and access to glottis. A laryngoscope will be inserted transorally under direct vision and suspended. Vocal cord cysts are visualized with microscope, and removed with microsurgery instruments with microflap technique and sent for routine section. After the surgery, the patient is kept nil-by-mouth until fully awake, and is discharged on same day or the next day depending on the post- operative recovery. Patient will be discharged with voice rest for 3 days. Receives: Procedure: Microlaryngeal surgery (MLS) |
| Awake transnasal laser-assisted surgery (TNLS) | Experimental | For TNLS, patients are admitted to the day center on the same morning or afternoon of the surgery with fasting prior 6 hours. After local anesthesia application, a 445nm blue laser is introduced via a working channel of bronchoscope and laser ablation of vocal cord cyst is performed. During the operation, patient will receive continuous SpO2 monitoring with regular blood pressure monitoring. After the procedure, patients are kept nil-by-mouth for 2 hours until anesthesia wears off, meanwhile with close observation in day ward with continuous SpO2 monitor for 1 hour. Patients will be discharged on the same day of the procedure, with voice rest for 3 days. Receives: Procedure: Awake transnasal laser-assisted surgery (TNLS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice-Handicap Index (VHI-30)
The primary outcome was to compare the pre- and post-operative Voice-Handicap Index 30 (VHI-30) of TNLS and MLS groups. The VHI-30 is a 30-item self-administered questionnaire, with score range from 0 to 120, and a score of 120 meaning worst voice score. It has been shown to be a reliable measure for voice treatment outcome. It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences a person's everyday functioning and experience.
Measured: From enrolment to post-operative 1year
Secondary outcomes (16)
Perceptual evaluation of voice
Perceptual evaluation of voice using the GBRAS scale, in which patients would be required to produce sustained vowel and connected speech voice samples. Score range from 0 to 15, with 15 being the worst score. Two experienced speech-language pathologists blinded to the patient's information would rate the audio recordings.
Measured: From enrolment to post-operative 1year
Acoustic voice analysis - Noise-to-Harmonic ratio (NHR)
Acoustic voice analysis will be performed using PRATT program; Noise-to-Harmonic ratio refers to the ratio between periodic and non-periodic components of a speech sound. A lower NHR score may indicate a worse voice outcome.
Measured: From enrolment to post-operative 1year
Acoustic voice analysis - Jitter
Acoustic voice analysis will be performed using PRATT program; Jitter refers to variation of voice frequency.
Measured: From enrolment to post-operative 1year
Acoustic voice analysis - Shimmer
Acoustic voice analysis will be performed using PRATT program; Shimmer refers to variation of intensity of the voice.
Measured: From enrolment to post-operative 1year
Aerodynamic measure of voice
Aerodynamic measure, maximal phonation time (MPT) would be measured by instructing patients to phonate /a:/ sound for as long as possible after maximal inspiration, at a spontaneous, comfortable pitch and loudness level, for three consequent trials.
Measured: From enrolment to post-operative 1year
Visual analog scale (VAS)
In VAS, patients would be asked to self-rate their voice quality on a visual analog scale of 0 (best) to 10 (worst).
Measured: From enrolment to post-operative 1year
Videostroboscopy - Mucosal wave pattern
Videostroboscopy would be conducted on all patients to look for any impaired mucosal wave form.
Measured: From enrolment to post-operative 1year
Videostroboscopy - Vocal fold closure
Videostroboscopy would be conducted on all patients to compare the degree of vocal fold closure.
Measured: From enrolment to post-operative 1year
Procedure-oriented outcomes - Reoperation
Comparison of the rate of reoperation for recurrence vocal cord cyst between two groups.
Measured: From perioperative period to post-operative 1 year
Procedure-oriented outcomes - Disease recurrence
Comparison of the rate of vocal cord cyst recurrence between two groups.
Measured: From perioperative period to post-operative 1 year
Procedure-oriented outcomes - Length of hospital stay
Comparison of the length of hospital stay (number of day) between two groups.
Measured: From perioperative period to post-operative 1 year
Procedure-oriented outcomes - Surgical complications in Clavien-Dindo classification
Clavien-Dindo classification is a commonly used surgical complication grading system, from grade I-V with grade V indicating worst outcome (death).
Measured: From perioperative period to post-operative 1 year
Procedure-oriented outcomes - Completeness of lesion removal
Indicates if the vocal fold pathology has been completely removed
Measured: From perioperative period to post-operative 1 year
Procedure-oriented outcomes - Operation time
Comparison of the operation time between two groups in terms of minute.
Measured: From perioperative period to post-operative 1 year
Patient-oriented outcomes
Patient-oriented outcomes included peri-operative throat, nose, and overall discomfort in visual analogue scale, a 10-point scale with 0 (least uncomfortable) to 10 (most uncomfortable).
Measured: Perioperative period
Medical costs
Medical costs of both interventions would be also calculated respectively, including costs for inpatient hospital stay, medical staff, operating theater and consumable.
Measured: From enrolment to post-operative 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Vocal Cord CystStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tam Aurora Ka Yue, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703515
- Sponsor's protocol ID
- NTEC-2023-624
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Misono S, Yueh B, Stockness AN, House ME, Marmor S. Minimal Important Difference in Voice Handicap Index-10. JAMA Otolaryngol Head Neck Surg. 2017 Nov 1;143(11):1098-1103. doi: 10.1001/jamaoto.2017.1621.
PubMed 28973078Ng E, Law T, Tang EC, Ho FN, Tong MC, Lee KY. The Cutoff Point and Diagnostic Accuracy of the Voice Handicap Index in Cantonese-Speaking Population. J Voice. 2021 Mar;35(2):163-168. doi: 10.1016/j.jvoice.2020.09.021. Epub 2020 Oct 9.
PubMed 33046276Gao WZ, Abu-Ghanem S, Reder LS, Amin M, Johns MM. A Novel Approach to Vocal Fold Mucous Retention Cysts: Awake KTP Laser-Assisted Marsupialization. J Voice. 2022 Jul;36(4):570-573. doi: 10.1016/j.jvoice.2020.07.028. Epub 2020 Aug 22.
PubMed 32843259Gocal WA, Tong JY, Maxwell PJ, Sataloff RT. Systematic Review of Recurrence Rates of Benign Vocal Fold Lesions Following Surgery. J Voice. 2025 May;39(3):787-798. doi: 10.1016/j.jvoice.2022.10.015. Epub 2022 Dec 10.
PubMed 36513559Hsu CM, Armas GL, Su CY. Marsupialization of vocal fold retention cysts: voice assessment and surgical outcomes. Ann Otol Rhinol Laryngol. 2009 Apr;118(4):270-5. doi: 10.1177/000348940911800406.
PubMed 19462847Courey MS, Gardner GM, Stone RE, Ossoff RH. Endoscopic vocal fold microflap: a three-year experience. Ann Otol Rhinol Laryngol. 1995 Apr;104(4 Pt 1):267-73. doi: 10.1177/000348949510400402.
PubMed 7717615Tam AKY, Leung NMW, Lee SKJ, Wei Y, Hu Y, Chan JYK, Law T. Randomized Controlled Trial of Awake Transnasal Laser-Assisted Surgery for Benign Laryngeal Lesions. Laryngoscope. 2024 Aug;134(8):3732-3740. doi: 10.1002/lary.31481. Epub 2024 May 10.
PubMed 38727019Schimberg AS, Wellenstein DJ, van den Broek EM, Honings J, van den Hoogen FJA, Marres HAM, Takes RP, van den Broek GB. Office-based vs. operating room-performed laryngopharyngeal surgery: a review of cost differences. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):2963-2973. doi: 10.1007/s00405-019-05617-z. Epub 2019 Sep 5.
PubMed 31486936Lin YH, Wang CT, Lin FC, Liao LJ, Lo WC, Cheng PW. Treatment Outcomes and Adverse Events Following In-Office Angiolytic Laser With or Without Concurrent Polypectomy for Vocal Fold Polyps. JAMA Otolaryngol Head Neck Surg. 2018 Mar 1;144(3):222-230. doi: 10.1001/jamaoto.2017.2899.
PubMed 29346486Wellenstein DJ, Honings J, Schimberg AS, Schutte HW, Herruer JM, van den Hoogen FJA, Takes RP, van den Broek GB. Office-based CO2 laser surgery for benign and premalignant laryngeal lesions. Laryngoscope. 2020 Jun;130(6):1503-1507. doi: 10.1002/lary.28278. Epub 2019 Sep 9.
PubMed 31498454Shoffel-Havakuk H, Sadoughi B, Sulica L, Johns MM 3rd. In-office procedures for the treatment of benign vocal fold lesions in the awake patient: A contemporary review. Laryngoscope. 2019 Sep;129(9):2131-2138. doi: 10.1002/lary.27731. Epub 2018 Dec 21.
PubMed 30575043
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Vocal Cord Cyst
- ClinicalTrials.gov ID
- NCT06703515
- Acronym / sponsor ID
- NTEC-2023-624
- Conditions
- Vocal Cord Cyst
- Keywords
- Vocal cord cyst, Transnasal laser surgery, Microlaryngeal surgery, Office based laser surgery, Awake laser laryngeal surgery, Trublue laser
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomised controlled trial conducted at two tertiary referral hospitals in Hong Kong to compare the clinical and functional outcomes of office-based awake transnasal laser-assisted laryngeal surgery (TNLS) under local anesthesia to traditional microlaryngeal surgery for vocal cord cyst under general anesthesia.
Detailed description
The aim of the study is to prospectively compare the functional and clinical outcomes of TNLS under local anesthesia and MLS under general anesthesia in managing vocal cord cysts.
Office-based awake transnasal laser-assisted surgery (TNLS) has been gaining popularity in treating different laryngeal lesions, with the advantages of avoiding general anesthetic risks and minimizing healthcare-related costs. In addition, the general waiting time for surgeries under general anesthesia in public hospitals is getting longer due to the increasing population and limited resources. The investigators have recently conducted a novel randomized controlled trial in 2021-2022 comparing the functional and cost-effectiveness of traditional microlaryngeal surgery (MLS) under general anesthesia and TNLS for benign laryngeal lesions (vocal cord polyps, nodules, cysts, granuloma and Reinke's edema), and found that TNLS was superior to MLS in terms of length of stay, intraoperative complications, perioperative throat discomfort and hospital costs; while it was equivalent to MLS in terms of functional outcome, operative time and recurrence rate. However, since the previous study's main goal was to compare TNLS to MLS in a macroscopic perspective in terms of functional outcomes and cost-effectiveness, it had included a wide variety of benign laryngeal lesions, and different vocal cord lesions may respond differently to laser surgery.
Vocal cord cyst is a fluid-filled sac inside the vocal cord, with 2 subtypes: 1) Epidermoid cyst due to epithelial inclusion 2) Mucous retention cyst due to glandular ductal obstruction. Vocal cord cysts typically do not resolve with voice therapy, and are traditionally excised with microlaryngeal surgery with microflap technique or marsupialization. In our previous RCT study, subgroup analysis did not show a significant difference of vocal cord cyst recurrence in both TNLS and MLS group. However, the investigators' cohort had a higher overall vocal cord cyst recurrence rate (13.8%) compared to historic cohort rate of 2.2-8.7% , which may be accounted by that the vocal cord cysts were ablated and marsupialized instead of removed in the TNLS group. Nevertheless, a recent case series by Gao and colleagues showed a good functional outcome of awake KTP-laser marsupialization in selected cases. A larger cohort is warranted to compare TNLS to MLS for vocal cord cyst. Therefore, the investigators would like to conduct a randomized controlled trial to compared tradition MLS surgery to TNLS, with hypothesis that TNLS would be non-inferior to traditional microlaryngeal surgery in benign laryngeal lesions, and with its additional benefits on minimization of anesthetic risks and hospital expenses, hopefully to expand its further application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microlaryngeal surgery (MLS) | Active comparator | Procedure: Microlaryngeal surgery (MLS)For traditional MLS under general anesthesia, after general anesthesia and intubation with microlaryngeal tube, the patient would be positioned on head-ring support for better alignment and access to glottis. A laryngoscope will be inserted transorally under direct vision and suspended. Vocal cord cysts are visualized with microscope, and removed with microsurgery instruments with microflap technique and sent for routine section. After the surgery, the patient is kept nil-by-mouth until fully awake, and is discharged on same day or the next day depending on the post- operative recovery. Patient will be discharged with voice rest for 3 days. |
| Awake transnasal laser-assisted surgery (TNLS) | Experimental | Procedure: Awake transnasal laser-assisted surgery (TNLS)For TNLS, patients are admitted to the day center on the same morning or afternoon of the surgery with fasting prior 6 hours. After local anesthesia application, a 445nm blue laser is introduced via a working channel of bronchoscope and laser ablation of vocal cord cyst is performed. During the operation, patient will receive continuous SpO2 monitoring with regular blood pressure monitoring. After the procedure, patients are kept nil-by-mouth for 2 hours until anesthesia wears off, meanwhile with close observation in day ward with continuous SpO2 monitor for 1 hour. Patients will be discharged on the same day of the procedure, with voice rest for 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with vocal cord cysts
- older than 18-year-old
- able to independently provide consent
- able to tolerate flexible laryngoscopy would be recruited
Key exclusion criteria (6 listed)
- under 18-year-old
- unable to independently give an informed consent
- unable to tolerate flexible laryngoscopy
- allergic to local anesthesia
- had unfavorable anatomy such as prolapsing epiglottis precluding adequate visualization, extensive lesions and an expected difficult operation as judged by the surgeons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Awake transnasal laser-assisted surgery (TNLS)For TNLS, patients are admitted to the day center on the same morning or afternoon of the surgery with fasting prior 6 hours. After local anesthesia application, a 445nm blue laser is introduced via a working channel of bronchoscope and laser ablation of vocal cord cyst is performed. During the operation, patient will receive continuous SpO2 monitoring with regular blood pressure monitoring. After the procedure, patients are kept nil-by-mouth for 2 hours until anesthesia wears off, meanwhile with close observation in day ward with continuous SpO2 monitor for 1 hour. Patients will be discharged on the same day of the procedure, with voice rest for 3 days. | Procedure or surgery | Awake transnasal laser-assisted surgery (TNLS) |
| Microlaryngeal surgery (MLS)For traditional MLS under general anesthesia, after general anesthesia and intubation with microlaryngeal tube, the patient would be positioned on head-ring support for better alignment and access to glottis. A laryngoscope will be inserted transorally under direct vision and suspended. Vocal cord cysts are visualized with microscope, and removed with microsurgery instruments with microflap technique and sent for routine section. After the surgery, the patient is kept nil-by-mouth until fully awake, and is discharged on same day or the next day depending on the post- operative recovery. Patient will be discharged with voice rest for 3 days. | Procedure or surgery | Microlaryngeal surgery (MLS) |
Primary outcome
Voice-Handicap Index (VHI-30)
Time frame: From enrolment to post-operative 1year
The primary outcome was to compare the pre- and post-operative Voice-Handicap Index 30 (VHI-30) of TNLS and MLS groups. The VHI-30 is a 30-item self-administered questionnaire, with score range from 0 to 120, and a score of 120 meaning worst voice score. It has been shown to be a reliable measure for voice treatment outcome. It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences a person's everyday functioning and experience.
16 secondary outcomes
Perceptual evaluation of voice
Time frame: From enrolment to post-operative 1year
Acoustic voice analysis - Noise-to-Harmonic ratio (NHR)
Time frame: From enrolment to post-operative 1year
Acoustic voice analysis - Jitter
Time frame: From enrolment to post-operative 1year
Acoustic voice analysis - Shimmer
Time frame: From enrolment to post-operative 1year
Aerodynamic measure of voice
Time frame: From enrolment to post-operative 1year
Visual analog scale (VAS)
Time frame: From enrolment to post-operative 1year
Videostroboscopy - Mucosal wave pattern
Time frame: From enrolment to post-operative 1year
Videostroboscopy - Vocal fold closure
Time frame: From enrolment to post-operative 1year
Procedure-oriented outcomes - Reoperation
Time frame: From perioperative period to post-operative 1 year
Procedure-oriented outcomes - Disease recurrence
Time frame: From perioperative period to post-operative 1 year
Procedure-oriented outcomes - Length of hospital stay
Time frame: From perioperative period to post-operative 1 year
Procedure-oriented outcomes - Surgical complications in Clavien-Dindo classification
Time frame: From perioperative period to post-operative 1 year
Procedure-oriented outcomes - Completeness of lesion removal
Time frame: From perioperative period to post-operative 1 year
Procedure-oriented outcomes - Operation time
Time frame: From perioperative period to post-operative 1 year
Patient-oriented outcomes
Time frame: Perioperative period
Medical costs
Time frame: From enrolment to post-operative 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 28973078Misono S, Yueh B, Stockness AN, House ME, Marmor S. Minimal Important Difference in Voice Handicap Index-10. JAMA Otolaryngol Head Neck Surg. 2017 Nov 1;143(11):1098-1103. doi: 10.1001/jamaoto.2017.1621.
- Background: PubMed 33046276Ng E, Law T, Tang EC, Ho FN, Tong MC, Lee KY. The Cutoff Point and Diagnostic Accuracy of the Voice Handicap Index in Cantonese-Speaking Population. J Voice. 2021 Mar;35(2):163-168. doi: 10.1016/j.jvoice.2020.09.021. Epub 2020 Oct 9.
- Background: PubMed 32843259Gao WZ, Abu-Ghanem S, Reder LS, Amin M, Johns MM. A Novel Approach to Vocal Fold Mucous Retention Cysts: Awake KTP Laser-Assisted Marsupialization. J Voice. 2022 Jul;36(4):570-573. doi: 10.1016/j.jvoice.2020.07.028. Epub 2020 Aug 22.
- Background: PubMed 36513559Gocal WA, Tong JY, Maxwell PJ, Sataloff RT. Systematic Review of Recurrence Rates of Benign Vocal Fold Lesions Following Surgery. J Voice. 2025 May;39(3):787-798. doi: 10.1016/j.jvoice.2022.10.015. Epub 2022 Dec 10.
- Background: PubMed 19462847Hsu CM, Armas GL, Su CY. Marsupialization of vocal fold retention cysts: voice assessment and surgical outcomes. Ann Otol Rhinol Laryngol. 2009 Apr;118(4):270-5. doi: 10.1177/000348940911800406.
- Background: PubMed 7717615Courey MS, Gardner GM, Stone RE, Ossoff RH. Endoscopic vocal fold microflap: a three-year experience. Ann Otol Rhinol Laryngol. 1995 Apr;104(4 Pt 1):267-73. doi: 10.1177/000348949510400402.
- Background: PubMed 38727019Tam AKY, Leung NMW, Lee SKJ, Wei Y, Hu Y, Chan JYK, Law T. Randomized Controlled Trial of Awake Transnasal Laser-Assisted Surgery for Benign Laryngeal Lesions. Laryngoscope. 2024 Aug;134(8):3732-3740. doi: 10.1002/lary.31481. Epub 2024 May 10.
- Background: PubMed 31486936Schimberg AS, Wellenstein DJ, van den Broek EM, Honings J, van den Hoogen FJA, Marres HAM, Takes RP, van den Broek GB. Office-based vs. operating room-performed laryngopharyngeal surgery: a review of cost differences. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):2963-2973. doi: 10.1007/s00405-019-05617-z. Epub 2019 Sep 5.
- Background: PubMed 29346486Lin YH, Wang CT, Lin FC, Liao LJ, Lo WC, Cheng PW. Treatment Outcomes and Adverse Events Following In-Office Angiolytic Laser With or Without Concurrent Polypectomy for Vocal Fold Polyps. JAMA Otolaryngol Head Neck Surg. 2018 Mar 1;144(3):222-230. doi: 10.1001/jamaoto.2017.2899.
- Background: PubMed 31498454Wellenstein DJ, Honings J, Schimberg AS, Schutte HW, Herruer JM, van den Hoogen FJA, Takes RP, van den Broek GB. Office-based CO2 laser surgery for benign and premalignant laryngeal lesions. Laryngoscope. 2020 Jun;130(6):1503-1507. doi: 10.1002/lary.28278. Epub 2019 Sep 9.
- Background: PubMed 30575043Shoffel-Havakuk H, Sadoughi B, Sulica L, Johns MM 3rd. In-office procedures for the treatment of benign vocal fold lesions in the awake patient: A contemporary review. Laryngoscope. 2019 Sep;129(9):2131-2138. doi: 10.1002/lary.27731. Epub 2018 Dec 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake transnasal laser-assisted surgery (TNLS) and Microlaryngeal surgery (MLS) in people with Vocal Cord Cyst, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurora KY Tam, MBBS, MRCSEd (+852-3505 1409, tky369@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice-Handicap Index (VHI-30) (time frame: From enrolment to post-operative 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06703515, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.