Randomized Controlled Trial of Awake Transnasal Laser-Assisted Surgery for Benign Laryngeal Lesions.

ABSTRACT

OBJECTIVE: To compare functional and cost-effectiveness of awake transnasal laser assisted-surgery versus microlaryngeal surgery for benign laryngeal lesions. METHODS: This was a prospective non-inferiority randomized controlled trial conducted from May 2021 to December 2022 at two tertiary referral hospitals in Hong Kong. Patients were block-randomized to receive either awake transnasal laser-assisted surgery or microlaryngeal surgery, with post-operative follow-up in a multidisciplinary voice clinic for 1-year. Primary outcome was Voice Handicap Index (VHI-30). Secondary outcomes included operation time, complications, length of stay, peri-operative discomfort, recurrence, and medical costs. RESULTS: Sixty-one patients were randomized to either awake transnasal laser-assisted surgery (n = 30) and microlaryngeal surgery (n = 31). Both groups had comparable demographics and laryngeal pathologies. Both groups showed significant improvement of VHI-30 score over time and had comparable post-operative VHI-30. Awake transnasal laser-assisted surgery group had a significantly shorter length of stay (0.5 vs. 1 day) and less throat discomfort (2 vs. 4) compared to microlaryngeal surgery group. Intraoperative complications were more common in microlaryngeal surgery group (14.3% vs. 0%). Otherwise, both groups had similar operative time and recurrence rate. Cost-analysis showed a significantly lower hospital cost for awake transnasal laser-assisted surgery (USD 3090) compared to microlaryngeal surgery group (USD 5120). CONCLUSION: Awake transnasal laser-assisted surgery was safe, functionally non-inferior, as measured by VHI-30, to microlaryngeal surgery in managing benign laryngeal lesions, while superior to microlaryngeal surgery in peri-operative discomfort and medical costs. LEVEL OF EVIDENCE 2 Laryngoscope, 1343732-3740, 2024.