Soolsma Jessica, van den Brekel Michiel W, Ackerstaff Annemieke H, Balm Alfons J, Tan Bing, Hilgers Frans J
Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
Laryngoscope. 2008 Feb;118(2):252-7. doi: 10.1097/MLG.0b013e318159ebde.
To assess the long-term results of the Provox ActiValve, a prosthesis for voice rehabilitation after total laryngectomy that was designed to lessen the need for frequent replacements caused by Candida and "underpressure."
Retrospective assessment of device lifetime, indications for replacement, voice quality, and maintenance issues, measured by a structured trial specific questionnaire, in a cohort of 42 laryngectomized patients, experiencing a short Provox2 device lifetime (median, 21 days).
The median device lifetime of Provox ActiValve, replaced for leakage through the device and those still in situ at the date of data collection (N = 32), was 337 days (mean 376 days): a statistically significant 16-fold increase compared to the Provox2 prosthesis (P < .001). In 10 patients, replacement was fistula-related (median after 86 days): esophageal pouch (N = 4), fistula granulation (N = 3), extrusion of the device (N = 2), and periprosthetic leakage (N = 1). Eighty-six percent of the patients used a special lubricant to diminish "stickiness" of the valve. Provox ActiValve was preferred by 90% of the patients who completed the trial-specific questionnaire.
For patients requiring frequent device-related replacements, Provox ActiValve, also long-term, provides a true solution and thereby is a valuable addition to prosthetic voice rehabilitation.
评估Provox ActiValve的长期效果,这是一种全喉切除术后语音康复假体,旨在减少因念珠菌感染和“负压”导致的频繁更换需求。
通过一份结构化的特定试验问卷,对42例全喉切除患者进行回顾性评估,这些患者使用Provox2装置的时间较短(中位数为21天),评估内容包括装置使用寿命、更换指征、语音质量和维护问题。
Provox ActiValve的装置使用寿命中位数为337天(平均376天),该装置因通过装置的渗漏而被更换,以及在数据收集时仍在位的装置(N = 32):与Provox2假体相比,在统计学上有显著的16倍增长(P <.001)。在10例患者中,更换与瘘管相关(中位数为86天后):食管囊(N = 4)、瘘管肉芽(N = 3)、装置挤出(N = 2)和假体周围渗漏(N = 1)。86%的患者使用特殊润滑剂来减少瓣膜的“粘性”。90%完成特定试验问卷的患者更喜欢Provox ActiValve。
对于需要频繁进行与装置相关更换的患者,Provox ActiValve长期来看提供了一个真正的解决方案,因此是假体语音康复的一个有价值的补充。