AIR:RRP: Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT03465280

Collaborator

Alder Hey Children's NHS Foundation Trust (Other), National Institute for Health Research, United Kingdom (Other)

400

Enrollment

Locations

Anticipated Duration (Months)

8.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Respiratory Papillomatosis Human Papilloma Virus	Procedure: Microdebrider Procedure: Cold-steel surgery (forceps) Procedure: Carbon dioxide laser Procedure: Potassium titanyl phosphate (KTP) laser Procedure: Pulsed dye laser Procedure: Radiofrequency ablation Procedure: Monopolar suction diathermy Procedure: Plasma coagulation Procedure: Other Other: Adjuvant therapies

Detailed Description

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:

build an evidence base of the different RRP treatments used across the UK which will help to formulate hypotheses for future research in RRP and improve quality of life for RRP patients;
inform National Institute for Health and Care Excellence (NICE) interventional procedure guidance on radiofrequency cold ablation (IPG434,2012), which is currently under special arrangements due to lack of safety and efficacy evidence;
identify common symptoms or signs associated with RRP disease profile, to aid future diagnosis of RRP;
determine the geographical spread of RRP patients across the UK, to inform effective use of future NHS resources and inform the Department of Health strategy in its quadrivalent HPV vaccination programme (protecting against four types of HPV including types 6 and 11 commonly associated with RRP) currently offered to 12-13 year old girls within the NHS childhood vaccination programme;
inform future development of national clinical guidance on management of RRP to ensure that everyone receives the best care based on best available current knowledge;
determine impact of COVID on RRP patients including changes to RRP management, RRP symptoms.

Objectives:

The investigators will make use of an existing secure online database platform (the Airway Intervention Registry, AIR - developed and hosted by The Newcastle upon Tyne Hospitals NHS Foundation Trust, NUTH) and its associated infrastructure and develop it to capture additional observational outcomes from standard clinical practice and quality of life questionnaires from RRP patients. All RRP patients (any age) receiving treatment in any UK NHS hospital will be eligible for inclusion. Data collection will be open for 53 months with no minimum follow-up required for patients. Due to its recurrent nature (requiring regular hospital visits to maintain an open airway), following this patient population will allow the investigators to determine both the short- and long-term relative safety and efficacy of RRP treatments used in the UK. Consent will be required (from patients/parent/guardian) before data are entered into the online database.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Airway Intervention Registry (AIR) Extension: Recurrent Respiratory Papillomatosis

Actual Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Outcome Measures

Primary Outcome Measures

Time interval between surgical interventions [Over study duration (53 months)]
Time between surgical interventions to maintain symptomatic control

Secondary Outcome Measures

RRP surgical intervention - nature [Over study duration (53 months)]
Nature of intervention
RRP surgical intervention - timing [Over study duration (53 months)]
Timing of intervention
RRP adjuvant therapy - nature [Over study duration (53 months)]
Nature of intervention
RRP adjuvant therapy - timing [Over study duration (53 months)]
Timing of intervention
Histology results [Over study duration (53 months)]
Including HPV type
Severity of papillomas [Over study duration (53 months)]
Measured via Derkay severity score (higher score corresponding with higher severity; clinical score range 0-11, anatomical score range 0-75, summed total score range 0-86)
Number of hospital visits/attendances [Over study duration (53 months)]
Inpatient, Accident & emergency, Outpatient
Voice assessment (paediatric) [Over study duration (53 months)]
Measured via paediatric voice handicap index (higher score corresponding with higher voice handicap, range 0-99)
Voice assessment (adult) [Over study duration (53 months)]
Measured via voice handicap index (higher score corresponding with higher voice handicap, range 0-120)
Short-term complications [During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days)]
Complications arising in-hospital
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)]
Planned discharge location (decided pre-operation)
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)]
Actual discharge location (occurring post-operation)
Long-term complications [Over study duration (53 months)]
Unexpected hospital, Accident & emergency (A&E), General Practitioner (GP) attendances due to RRP symptoms.
Impact of COVID [From March 2020 onwards (30 months)]
Test results, antibody results, symptoms, changes to management,

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

patients participating in other studies

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	NHS Grampian	Aberdeen	United Kingdom	AB25 2ZB
2	Betsi Cadwaladr University Health Board,	Bangor	United Kingdom	LL57 2PW
3	Basildon & Thurrock University Hospitals NHS FT	Basildon	United Kingdom	SS165NL
4	Belfast Health and Social Care Trust	Belfast	United Kingdom	BT2 8BG
5	University Hospital Birmingham NHS Foundation Trust	Birmingham	United Kingdom	B15 2GW
6	Birmingham Women's and Children's NHS Foundation Trust	Birmingham	United Kingdom	B4 6NH
7	Blackpool Teaching Hospital NHS FT	Blackpool	United Kingdom	FY38NR
8	Bradford Teaching Hospitals NHS Foundation Trust	Bradford	United Kingdom	BD9 6RJ
9	Cambridge University Hospitals NHS Foundation Trust	Cambridge	United Kingdom	CB2 0QQ
10	Cardiff and Vale University Local Health Board	Cardiff	United Kingdom	CF14 4XW
11	North Cumbria Univeristy Hospital NHS Trust	Carlisle	United Kingdom	CA27HY
12	Hywel Dda University Health Board	Carmarthen	United Kingdom	SA31 3BB
13	County Durham and Darlington NHS Foundation Trust	Darlington	United Kingdom	DL36HX
14	University Hospitals of Derby and Burton NHS Foundation Trust	Derby	United Kingdom	DE223NE
15	Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust	Doncaster	United Kingdom	DN2 5LT
16	NHS Tayside	Dundee	United Kingdom	DD2 1GZ
17	NHS Lothian	Edinburgh	United Kingdom	EH16 4TJ
18	Frimley Health NHS Foundation Trust	Frimley	United Kingdom	GU16 7UJ
19	NHS Greater Glasgow & Clyde	Glasgow	United Kingdom	G120XH
20	London North West University Healthcare NHS Trust	Harrow	United Kingdom	HA1 3UJ
21	Leeds Teaching Hospitals NHS Trust	Leeds	United Kingdom	LS9 7TF
22	Alder Hey Children's NHS Foundation Trust	Liverpool	United Kingdom	L12 2AP
23	Liverpool University Hospitals NHS Foundation Trust	Liverpool	United Kingdom	L7 8XP
24	Barts Health NHS Trust	London	United Kingdom	E1 2ES
25	University College London Hospitals NHS Foundation Trust	London	United Kingdom	NW1 2PG
26	Guy's and St Thomas' NHS Foundation Trust	London	United Kingdom	SE1 7EH
27	Lewisham and Greenwich NHS Trust	London	United Kingdom	SE13 6LH
28	St George's University Hospitals NHS Foundation Trust	London	United Kingdom	SW17 0QT
29	Imperial College Healthcare NHS Trust	London	United Kingdom	W2 1NY
30	Great Ormond Street Hospital for Children NHS FT	London	United Kingdom	WC1N3JH
31	Bedfordshire Hospitals NHS Foundation Trust	Luton	United Kingdom	LU4 0DZ
32	Manchester University Hospital NHS Foundation Trust	Manchester	United Kingdom	M13 9WL
33	Pennine Acute Hospitals NHS Trust	Manchester	United Kingdom	M8 5RB
34	South Tees Hospitals NHS Foundation Trust	Middlesbrough	United Kingdom	TS4 3BW
35	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne	United Kingdom	NE7 7DN
36	Isle of Wight NHS Trust	Newport	United Kingdom	PO30 5TG
37	Nottingham University Hospitals NHS Trust	Nottingham	United Kingdom	NG51PB
38	Oxford University Hospitals NHS Foundation Trust	Oxford	United Kingdom	OX3 9DU
39	University Hospital of Plymouth NHS Trust	Plymouth	United Kingdom	PL6 8DH
40	Swansea Bay University Health Board	Port Talbot	United Kingdom	SA12 7BR
41	East Sussex Healthcare NHS Trust	Saint Leonards-on-Sea	United Kingdom	TN37 7PT
42	Salford Royal NHS Foundation Trust	Salford	United Kingdom	M6 8HD
43	Sheffield Children's NHS Foundation Trust	Sheffield	United Kingdom	S10 2TH
44	The Shrewsbury and Telford Hospital NHS Trust	Shrewsbury	United Kingdom	SY3 8XQ
45	University Hospital Southampton NHS Foundation Trust	Southampton	United Kingdom	SO16 6YD
46	Stockport NHS Foundation Trust	Stockport	United Kingdom	SK2 7JE
47	South Tyneside and Sunderland NHS Foundation Trust	Sunderland	United Kingdom	SR4 7TP
48	Wirral University Teaching Hospitals NHS Foundation Trust	Wirral	United Kingdom	CH49 5PE