Airway Intervention Registry (AIR) Extension: Recurrent Respiratory Papillomatosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 48
- 主要终点
- Time interval between surgical interventions
研究概览
简要总结
Recurrent Respiratory Papillomatosis (RRP) causes wart-like growths in the airway which can make it difficult to breathe, speak and carry out normal everyday activities. It is a rare condition affecting all ages, but is more common and aggressive in children than in adults, affecting 4 in every 100,000 children. There is no known cure for RRP, but symptoms are checked through regular hospital visits, with multiple therapies or procedures under general anaesthetic needed to remove or shrink the growths which can grow back quickly. The problem is that nobody knows which therapies or procedures work best. Aim: To identify which RRP treatments currently used in National Health Service (NHS) hospitals within the United Kingdom (UK) are the most effective and safest in the short- and long-term. It will also identify which patients respond best to specific treatments, and those who are at higher risk of experiencing a complication after treatment.
Method: Collect information from usual patient care and quality of life questionnaire responses in a secure online database. Participation in this study requires patient/parent/guardian consent. This observational study does not require patients to undergo any additional intervention as part of the research.
详细描述
Primary aim:
The overall goal is to improve the care of patients with Recurrent Respiratory Papillomatosis (RRP) - and the investigators aim to do this by determining the most effective and safe RRP treatments currently being used in patients in National Health Service (NHS) hospitals within the United Kingdom (UK) (information which is currently lacking).
By determining the most effective treatments of RRP, the investigators will be able to increase the time interval between surgical interventions to maintain symptomatic control, reduce overall number of RRP interventions, severity and spread of papillomas in the airway, hospital visits, medications and ultimately improve quality of life in those suffering from RRP. By also capturing peri- and post-procedural details the investigators will be able to determine the relative safety of treatments and identify those which slow the progression of disease.
From the data collected the investigators intend to identify patient subgroups (based on patient characteristics such as age, gender, human papillomavirus (HPV) type, location of papillomas, RRP severity and spread, comorbidities) who respond better to specific treatments, and also identify patient risk factors which contribute to the complication outcomes (such as tracheostomy).
Secondary aims:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of any age (no restrictions) diagnosed with (newly diagnosed or existing) and receiving treatment for respiratory papillomatosis
- •informed assent/consent of data participation provided by patient/parent/guardian
排除标准
- •patients participating in other studies
结局指标
主要结局
Time interval between surgical interventions
时间窗: Over study duration (53 months)
Time between surgical interventions to maintain symptomatic control
次要结局
- RRP surgical intervention - timing(Over study duration (53 months))
- RRP adjuvant therapy - timing(Over study duration (53 months))
- Histology results(Over study duration (53 months))
- Post-operative discharge location - planned(During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days))
- Post-operative discharge location - actual(During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days))
- Impact of COVID(From March 2020 onwards (30 months))
- RRP surgical intervention - nature(Over study duration (53 months))
- Voice assessment (paediatric)(Over study duration (53 months))
- RRP adjuvant therapy - nature(Over study duration (53 months))
- Severity of papillomas(Over study duration (53 months))
- Long-term complications(Over study duration (53 months))
- Voice assessment (adult)(Over study duration (53 months))
- Number of hospital visits/attendances(Over study duration (53 months))
- Short-term complications(During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days))