Clinical trial NCT05665829: Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Benign Laryngeal Lesions
Official title: Randomised Controlled Trial of Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Benign Laryngeal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Awake Laser
Microlaryngeal Surgery
Benign Laryngeal Lesion
Transnasal Laser Surgery
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomised controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective, single-cluster randomised controlled trial conducted at two tertiary referral hospitals in Hong Kong to compare the clinical and functional outcomes of office-based transnasal laser-assisted surgery (TNLS) under local anesthesia to traditional microlaryngeal surgery (MLS) under general anesthesia.

Detailed description: Patients with benign laryngeal lesions were block-randomized to either TNLS or traditional MLS group. Pre-operative diagnosis and post-operative follow-up were conducted in a multidisciplinary voice clinic. All patients were followed up at 2-week, 6-week, 3-month, 6-month and 1-year post-operation. Primary outcome included functional vocal measures using Voice-Handicap index (VHI-30). Secondary outcomes included length of stay, patient-perceived procedural discomfort, complications, operative time, recurrence rate, reoperation rate, and medical cost.

Eligibility criteria: Inclusion Criteria:

* older than 18-year-old
* mentally competent to give an informed consent
* operable benign laryngeal lesions
* able to tolerate transnasal flexible laryngoscopy

Exclusion Criteria:

* under 18-year old
* unable to give an informed consent
* unable to tolerate flexible laryngoscopy under local anesthesia
* allergy to local anesthesia
* unfavourable anatomy precluding adequate visualization
* with extensive lesions with expected difficult operation
* with pathologies suspicious of or confirmed malignancy

Primary outcomes:
measure: Voice-Handicap Index (VHI-30)
timeFrame: Post-op 2 week
measure: Voice-Handicap Index (VHI-30)
timeFrame: Post-op 6 week
measure: Voice-Handicap Index (VHI-30)
timeFrame: Post-op 3 month
measure: Voice-Handicap Index (VHI-30)
timeFrame: Post-op 6 month
measure: Voice-Handicap Index (VHI-30)
timeFrame: Post-op 1 year
Secondary outcomes:
measure: Procedure-oriented outcomes
timeFrame: Intraoperative
measure: Procedure-oriented outcomes
timeFrame: Intraoperative
measure: Procedure-oriented outcomes
timeFrame: Intraoperative
measure: Procedure-oriented outcomes
timeFrame: Perioperative
measure: Procedure-oriented outcomes
timeFrame: Post-op 2 week, 6 week, 3 month, 6 month, 1 year
measure: Procedure-oriented outcomes
timeFrame: 1 year
measure: Cost
timeFrame: Peri-operative
measure: Patient-perceived procedural discomfort
timeFrame: Immediate post-operation
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: