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首页> 外文期刊>Oral oncology >A prospective randomized multicenter clinical trial of the Provox2 and Groningen Ultra Low Resistance voice prostheses in the rehabilitation of post-laryngectomy patients: a lifetime and preference study.
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A prospective randomized multicenter clinical trial of the Provox2 and Groningen Ultra Low Resistance voice prostheses in the rehabilitation of post-laryngectomy patients: a lifetime and preference study.

机译：Provox2和Groningen超低抵抗语音假体在喉切除术后患者康复中的前瞻性随机多中心临床试验：终生和偏爱研究。

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摘要

To prospectively study patients' preference for and the lifetime of the Groningen Ultra Low Resistance (GULR) and Provox2 tracheo-esophageal shunt prosthesis (TESP, plural TESPs) in post-laryngectomy patients. Eighty post-laryngectomy patients were included in 4 oncological centers in the Netherlands. We used a repeated measures design study with 4 randomized groups in a partial cross-over design using 3 consecutive TESPs (3 intervals) in different orders. (Group 1: GULR-GULR-GULR; Group 2: GULR-GULR-Provox2; Group 3: Provox2-Provox2-GULR; and Group 4: Provox2- Provox2-Provox2). Replacement dates and reasons for replacement were monitored with questionnaires as were patients' preferences for GULR or Provox2. A great variability of lifetime within and between groups was seen. Mean lifetimes found (all groups and intervals added) were 106.2 and 102.7 days, and median lifetimes were 76 and 65 days for GULR and Provox2, respectively. Lifetime showed no significant differences between groups, intervals, and TESP types. Many patients dropped out due to reasons having to do with GULR-characteristics (n=21). The main dropout reason was "high phonating resistance (HPR)" (57.1%). Only 10 patients preferred GULR. A significantly larger number of patients (n=39, 79.6%) preferred Provox2 either by choice or by dropping out due to GULR-characteristics (P<0.001). The main replacement reasons were "leakage though TESP" (GULR 59.1%, Provox2 52.1%) and HPR (GULR 15.9%, Provox2 12.7%). No significant differences in lifetime between GULR and Provox2 were found. The patients' preference for Provox2 was significant (P<0.001). Patients' preference was a more important outcome measurement in TESP effectiveness than device lifetime.
机译：前瞻性研究喉切除术后患者对Groningen超低抵抗性（GULR）和Provox2气管食管分流假体（TESP，多个TESP）的偏好和寿命。荷兰的4个肿瘤学中心收治了80名喉切除术后患者。我们在3个连续TESP（3个间隔）中以不同顺序在部分交叉设计中使用了4个随机分组的重复测量设计研究。 （组1：GULR-GULR-GULR;组2：GULR-GULR-Provox2;组3：Provox2-Provox2-GULR;组4：Provox2-Provox2-Provox2）。用问卷调查替换日期和替换原因，以及患者对GULR或Provox2的偏好。两组之间和组之间的寿命存在很大差异。发现的平均寿命（所有组和添加的间隔）为106.2天和102.7天，GULR和Provox2的中位寿命分别为76天和65天。寿命在各组，间隔和TESP类型之间没有显着差异。许多患者由于与GULR特征有关的原因而辍学（n = 21）。辍学的主要原因是“高发声阻力（HPR）”（57.1％）。只有10例患者首选GULR。由于GULR的特性，选择或退出治疗的患者中，有相当多的患者（n = 39，79.6％）偏爱Provox2（P <0.001）。更换的主要原因是“通过TESP泄漏”（GULR 59.1％，Provox2 52.1％）和HPR（GULR 15.9％，Provox2 12.7％）。在GULR和Provox2之间没有发现寿命上的显着差异。患者对Provox2的偏爱显着（P <0.001）。患者的喜好是衡量TESP效果比设备寿命更重要的结果。

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