Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Patient satisfaction in regards to the scar (change)
研究概览
简要总结
The mean of this study is to compare primary and secondary closure of tracheo-cutaneous fistulas and evaluate the differences in outcomes between both techniques.
详细描述
In this study the investigators wish to recruit patients with a tracheotomy that has been installed for various reasons and that is ready for closure. The investigators intend to randomly allocate them a mean of closure, either primary or secondary. Once the fistula is closed, the investigators will follow them over a substantial period of time to compare outcomes of each mean of closing. Different questionnaires will be used to best evaluate a range of variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking because it is a surgical procedure
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being covered by the RAMQ
- •Having a tracheostomy either percutaneous or surgical
- •Being ready for canula removal and closure of the fistula
排除标准
- •Presenting a contraindication to primary tracheotomy closure (granuloma)
- •Unable to consent
- •Refusal to participate
结局指标
主要结局
Patient satisfaction in regards to the scar (change)
时间窗: 1 week, 1 month, 3 months, 6 months
This outcome will evaluate patient satisfaction in regards to his tracheotomy scar following closure, measured with the Patient observer scar assesment scale (POSAS) validated questionnaire. A high score means a worse outcome.
次要结局
- Healing time(6 months)
- Self reported quality of life related to dysphagia (change)(1 week, 1 month, 3 months, 6 months)
- Persisting fistula(6 months)
- Self reported quality of life related to dyspnea (change)(1 week, 1 month, 3 months, 6 months)
- Respiratory complications(6 months)
- Self reported quality of life related to dysphonia (change)(1 week, 1 month, 3 months, 6 months)
研究者
Simon Brisebois
Assistant Professor - Division of Otolaryngology - Head & Neck Surgery
Université de Sherbrooke