目的:许多系列比较了cT1声门癌放疗或手术后的声音质量。不同的荟萃分析确定了更好的结果为放疗,而其他不确定任何差异,有些人终于找到了手术的优越性。这项研究的目的是比较接受经口手术与单纯放疗治疗cT1声门癌的患者的长期语音质量。
方法:VOQUAL研究是一项多中心横断面试验比较研究。主要终点是两组(放疗或手术)之间的语音障碍指数比较。语音评估还包括按年级对语音质量的异质评估,粗糙度,呼吸,Asthenia,和平野报告的应变等级量表。
结果:该研究包括41例cT1声带癌的成人患者,在两个肿瘤中心接受了声带切除术或单纯放疗。手术组的语音障碍指数值中位数为20[8;32.5],放疗组为10[4;18.5]。中值与各成分F之间无统计学差异,问卷的P和E(P=0.1585)。数字发音障碍等级的中值,粗糙度,呼吸,Asthenia,手术组为2[0;5],放疗组为2[0.25;3.75]。这些值之间没有统计学上的显著差异(P=0.78)。
结论:我们的研究在语音障碍指数和等级的主要终点上没有显示任何显着差异,粗糙度,呼吸,Asthenia,和应变分数。
方法:III.
背景:VOQUAL研究于2020年7月在ClinicalTrials.gov平台上注册,编号为NCT04447456。
OBJECTIVE: Many series have compared voice quality after radiotherapy or surgery for cT1 glottic carcinoma. Different meta-analyses identify better results for radiotherapy while others do not identify any difference, some finally find a superiority of surgery. The purpose of this study was to compare the voice quality in the long term of patients who underwent transoral surgery versus exclusive irradiation for the treatment of cT1 glottic carcinoma.
METHODS: The VOQUAL study was a pilot comparative multicenter cross-sectional study. The primary endpoint was the Voice Handicap Index comparison between two groups (radiotherapy or surgery). The voice assessment also consisted in the heteroevaluation of voice quality by the Grade, Roughness, Breathness, Asthenia, and Strain rating scale reported by Hirano.
RESULTS: The study included 41 adult patients with cT1 carcinoma of the vocal cord treated by cordectomy or exclusive radiation in two oncologic centers. The median Voice Handicap Index value was 20 [8; 32.5] in the surgery group and 10 [4; 18.5] in the radiotherapy group. There was no statistically significant difference between the median values and the various components F, P and E of the questionnaire (P=0.1585). The median value of the numeric dysphonia Grade, Roughness, Breathness, Asthenia, and Strain scale was 2 [0; 5] in the surgery group and 2 [0.25; 3.75] in the radiotherapy group. There was no statistically significant difference between these values (P=0.78).
CONCLUSIONS: Our study did not show any significant difference on the primary endpoints of Voice Handicap Index and Grade, Roughness, Breathness, Asthenia, and Strain scores.
METHODS: III.
BACKGROUND: The VOQUAL study was registered on the ClinicalTrials.gov platform under the number NCT04447456, in July 2020.