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临床试验/NCT04268459
NCT04268459Unknown不适用

Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy Considering Complications Rate, Fistula Colonization by Candida Species and Patients Satisfaction Feedback.

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
2
主要终点
Comparison of complications rate.

研究概览

简要总结

The tracheoesophageal voice with voice prosthesis is currently the mainstay of voice rehabilitation post laryngectomy. The primary surgical technique of tracheoesophageal fistula formation with insertion of prosthesis and quick and easy process of voice rehabilitation are main encouraging factors. However, the usage of the prosthesis relates to a significant number of complications rated from 10 to 60%. The most common reported complication is transprosthetic leakage that determines the need of device exchange. However in some patients occur more serious complications eg. periprosthetic leakage, granulation or atrophy of mucosa around the fistula, dislocation of prosthesis, that may require anti-inflammatory treatment, temporary nasogastric tube feeding or surgical procedure. The standard protocol is voice prosthesis exchange due to transprosthetic leakage. Optionally the device could be replaced regularly to prevent both transprosthetic leakage and other complication occurrence.

In the study we plan to compare the benefits from regular (each three month) versus leakage-related exchange of voice prosthesis post laryngectomy including the rate of complications, fistula colonization by Candida species and patients feedback.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients post laryngectomy with primary insertion of voice prosthesis

排除标准

  • patients post laryngopharyngectomy with digestive tract reconstruction with jejunum of free flap

结局指标

主要结局

Comparison of complications rate.

时间窗: Control will be continued for 12 months post laryngectomy.

In both arms of the study we will compare the incidence of following complications: periprosthetic leakage, granulation or atrophy of mucosa around the fistula, dislocation of prosthesis

次要结局

  • Fistula colonization with Candida species.(Control will be continued for 12 months post laryngectomy.)
  • Prosthesis replacement scheme and patient satisfaction.(Control will be continued for 12 months post laryngectomy.)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Rzepakowska

MD, PhD

Medical University of Warsaw

研究点 (2)

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