Birchall Martin, Iliadou Eleftheria, Blackshaw Helen, Jepson Marcus, Carding Paul, Husbands Samantha, Heathcote Kate, Mat Baki Marina, Karagama Yakubu, Ambler Gareth
Ear Institute, University College London, London, UK.
National and Kapodistrian University of Athens, Athens, Greece.
Laryngoscope. 2025 Sep;135(9):3320-3329. doi: 10.1002/lary.32230. Epub 2025 May 5.
We wished to determine the feasibility of performing a multi-centre phase III randomized controlled trial that compares laryngeal reinnervation to type I thyroplasty for adults with unilateral vocal fold paralysis (UVFP) in the UK.
A feasibility study was designed; 27 participants were recruited at three UK sites. Trial procedures mirrored those intended for a full-scale trial. We assessed recruitment rates, acceptability of randomization, and dropout rates and conducted a qualitative study to understand the recruitment processes. Participants were followed up for up to 12 months to assess optimal outcome measures for the definitive trial covering voice, swallowing, and overall quality of life. A qualitative study was run in parallel with the quantitative clinical trial.
Recruitment was successful with 23 patients with UVFP randomized to reinnervation (n = 12) and thyroplasty (n = 11). 96% (n = 22) of participants accepted the treatment to which they were allocated, of which 17 received their intervention before the study end date. The qualitative study identified minor recruitment challenges that could be addressed through in-trial training. The set of subjective and objective voice, swallowing, and quality of life outcome measures used demonstrated a responsiveness to change following interventions.
The results from this study have provided us with the assurance that conducting an adequately powered randomized controlled clinical trial of laryngeal reinnervation versus type I thyroplasty for adults with UVFP in the UK is feasible in terms of conduct, recruitment, outcome measurement, and completion.
ISRCTN90201732.
我们希望确定在英国开展一项多中心III期随机对照试验的可行性，该试验比较喉再支配术与I型甲状软骨成形术治疗成人单侧声带麻痹（UVFP）的效果。
设计了一项可行性研究；在英国的三个地点招募了27名参与者。试验程序与全面试验的程序相同。我们评估了招募率、随机分组的可接受性和退出率，并进行了一项定性研究以了解招募过程。对参与者进行了长达12个月的随访，以评估确定性试验的最佳结局指标，包括嗓音、吞咽和总体生活质量。在定量临床试验的同时进行了一项定性研究。
招募成功，23例UVFP患者被随机分配接受再支配术（n = 12）和甲状软骨成形术（n = 11）。96%（n = 22）的参与者接受了分配给他们的治疗，其中17人在研究结束日期前接受了干预。定性研究确定了一些可以通过试验内培训解决的轻微招募挑战。所使用的主观和客观嗓音、吞咽及生活质量结局指标显示出对干预后变化的反应性。
本研究结果使我们确信，在英国针对成人UVFP患者开展一项关于喉再支配术与I型甲状软骨成形术的有足够效力的随机对照临床试验，在实施、招募、结局测量和完成方面是可行的。
ISRCTN90201732。
