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NCT Number: NCT05665829

Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Benign Laryngeal Lesions

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.

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Key information

Conditions

Awake Laser Benign Laryngeal Lesion Microlaryngeal Surgery Transnasal Laser Surgery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Awake transnasal laser-assisted surgery (TNLS)

Procedure

The experimental intervention would be awake transnasal laser-assisted surgery under local anesthesia, carried out in minor operation theater as a day-case basis in ENT ambulatory center.

Microlaryngeal surgery (MLS)

Procedure

For traditional MLS under general anesthesia, laryngeal lesions are visualized and removed with under microscopic or endoscopic approach.

Primary outcomes

  1. Voice-Handicap Index (VHI-30)

    Time frame: Post-op 2 week

    The VHI-30 is a 30-item self-administered questionnaire, which is 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 on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.

  2. Voice-Handicap Index (VHI-30)

    Time frame: Post-op 6 week

    The VHI-30 is a 30-item self-administered questionnaire, which is 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 on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.

  3. Voice-Handicap Index (VHI-30)

    Time frame: Post-op 3 month

    The VHI-30 is a 30-item self-administered questionnaire, which is 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 on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.

  4. Voice-Handicap Index (VHI-30)

    Time frame: Post-op 6 month

    The VHI-30 is a 30-item self-administered questionnaire, which is 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 on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.

  5. Voice-Handicap Index (VHI-30)

    Time frame: Post-op 1 year

    The VHI-30 is a 30-item self-administered questionnaire, which is 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 on a person's everyday functioning and experience. It has a overall score range from 0 to 120, 0 as the best score, 120 as the worst score.

Secondary outcomes

  1. Procedure-oriented outcomes

    Time frame: Intraoperative

    Operation time

  2. Procedure-oriented outcomes

    Time frame: Intraoperative

    Completeness of lesion removal

  3. Procedure-oriented outcomes

    Time frame: Intraoperative

    Complications in Clavien-Dindo classification

  4. Procedure-oriented outcomes

    Time frame: Perioperative

    Length of hospital stay

  5. Procedure-oriented outcomes

    Time frame: Post-op 2 week, 6 week, 3 month, 6 month, 1 year

    Recurrence rate

  6. Procedure-oriented outcomes

    Time frame: 1 year

    Reoperation

  7. Cost

    Time frame: Peri-operative

    Medical costs including surgery-related and hospitalization-related costs are estimated.

  8. Patient-perceived procedural discomfort

    Time frame: Immediate post-operation

    Discomfort in visual analog scale, from 0 to 10, 0 as least discomfort, 10 as most uncomfortable.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Randomised Controlled Trial of Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Benign Laryngeal Lesions

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 27, 2022
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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