Current practice variance in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) is not efficient. Endoscopicsinus surgery (ESS) is the most common ENT operation in adults in the Netherlands. The objective of the present study is…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary clinical endpoint is HRQol in CRSwNP patients, measured by the
SNOT-22 at 12 months follow-up. HRQol is a
frequently used clinical endpoint in CRS clinical trials.
Secondary outcome
Secondary study parameters/endpoints include
The effectiveness of ESS in addition to drug treatment as compared to drug
treatment alone in adults with CRSwNP in the short (3-6 months) and long (12 -
24 months) term, in terms of:
* Generic HRQoL (EQ-5D-5L)
* Disease specific HRQoL and symptoms (SNOT-22)
* Endoscopic assessment of the nose (Endoscopic assessment of the nasal cavity,
graded using the Lildholt scale (0 * no
polyps, 1-confined to middle meatus, 2-below middle turbinate. 3- massive
polyposis)
* Endoscopic assessment of the nose (Lund-Kennedy endoscopy scores and Modified
Lund Mackay Postoperative
Endoscopy Score)
* Olfactory function (Sniffin Sticks)
* Nasal obstruction (PNIF)
* Daily records cards (DRC) will be provided 2 weeks before until 2 weeks after
a visit to the clinic to record daily
symptoms, medication use, adverse events, healthcare resource use and related
health care costs
* CRS disease control (EPOS CRS control test, NOSE test)
* Asthma control in the subgroup of patients with asthma (Asthma Control Test)
* Symptomatic exacerbations requiring further treatment including ESS
identified using diaries and medical notes
* Adverse effects of drug and surgical treatment and readmissions identified
using diaries and medical notes
* Healthcare resource use and related health care costs including patient time
and travel costs, out-of-pocket expenditure,
time off education, work and usual activities using repeated questionnaires and
diaries (DRC)
Baseline data collection for the RCT include
Most of the measurements described above. On top of that we will collect the
following measurements:
* CT scan (Lund-Mackay score)
* If surgery is performed a surgical report indicating which sinus are opened
and what was found there (surgical report with
standard items) will be made
* Laboratory results including total IgE and serum eosinophils
* Earlier sinus surgery with dates and estimation of extent (based on CT scan)
* Skin Prick test (if done in the last year, results are recorded)
* Structured history with questions on allergy, smoking, asthma, aspirin
intolerance, other diseases, and occupational
exposure.
* Bodyweight, bloodpressure and heartrate
Background summary
Given its prevalence (11% in Europe, 14,6% in the Netherlands) and the
significant negative effect on quality of life, the diagnosis and treatment of
chronic rhinosinusitis (CRS) is associated with a significant medical resource
use and societal economic burden (1, 2). CRS has been shown to have a negative
impact on most aspects of Health related Quality of Life HRQoL), and has a
greater impact on HRQoL than chronic heart failure, angina, diabetes or back
pain (1, 3). CRS is the most common reason for surgery (ESS) in adult patients
in the otorhinolaryngological practice with around 18,000 ESS performed in The
Netherlands yearly (2010 data stichting hospital data (DHD)). CRS can be
divided into the more serious disease CRS with nasal polyps (CRSwNP)
(prevalence 1-4%) and CRS without nasal polyps (CRSsNP). Around 70% of the ESS
is done in patients with CRSwNP.
Surgery requires anaesthesia and convalescence and has a small but relevant
risk of serious (intracranial) complications (1). At present it is unknown
whether ESS added to drug treatment offers significant benefits over drug
treatment alone. Implementation of the results of this study will lead to
tailored care for CRS, improvement of clinical pathways for relevant phenotypes
and a considerable reduction of the number of ESS in in the Netherlands.
The indications for and timing of ESS in CRS management are mainly practice
based. At present it is unknown whether
endoscopic sinus surgery (ESS) added to drug treatment offers significant
benefits over drug treatment alone. National and
international clinical guidelines advise to start with drug treatment for at
least 1 month before considering surgical intervention
(2, 6, 7). Currently, patients failing drug treatment are offered a choice of
surgery on addition to drug treatment or on-going
more intense drug treatment alone. The costs and benefits of ESS over more
intensive drug treatment in the treatment of adult
patients with chronic rhinosinusitis with nasal polyps (CRSwNP) are unclear and
50% of the patients with CRSwNP have
multiple (repetitive) surgeries and long time burden of disease. The need for
long term health care use (intermittent and
repetitive) can be costly, so tailored-based alternatives should be preferred
in CRS disease management.
There is a significant individual practice variance within the Netherlands and
also in contrast to other western-countries with
more than average surgery in The Netherlands. Scientific evidence for the
effectiveness and adequate timing of ESS is scarce
and (inter)nationally accepted standardized clinical guidelines are lacking.
The positioning of surgery (ESS) in the treatment of
patients with CRSwNP has been acknowledged as one of the most important
knowledge gaps for which an RCT is warranted
by the Dutch Society of Otolaryngology (top priority pg 17
www.kno.nl/publiek/document/2908), the CBO guideline CRS (6), the
EU Pos. paper on CRS (2) and the patient society of CRS-NP (letters of support
as addendum). An estimated reduction of
30-50% of performed ESS interventions for CRSwNP (based on percentages in other
western countries) would save 15-26
million euros annually without impairment of HRQoL.
Study objective
Current practice variance in adult patients with chronic rhinosinusitis with
nasal polyps (CRSwNP) is not efficient. Endoscopic
sinus surgery (ESS) is the most common ENT operation in adults in the
Netherlands. The objective of the present study is to
investigate whether two regular used strategies (*ESS in addition to drug
treatment (usual care)* versus *drug treatment alone*)
in adults with CRSwNP differ in improvement in health related quality of life
(SNOT-22, EQ-5D-5L) at 12 months follow-up.
Furthermore both strategies will be compared with respect to
cost-effectiveness. Secondary outcomes are generic and disease
specific HRQOL, cost-effectiveness, endoscopic assessment of the nose,
olfactory function, nasal obstruction, asthma control
and adverse events, in the short (3-6 months) and long (12 - 24 months) term.
Because the average time to revision surgery
can be considerable a longer follow-up is advisable.
In this open multi-centre randomized controlled trial in 238 adults with CRSwNP
selected for ESS (usual care) are randomized
to ESS in addition to drug treatment (usual care) or drug treatment alone. We
hypothesize that ESS in addition to drug
treatment has no or limited health benefit in terms of HRQoL compared to drug
treatment alone in the treatment of CRSwNP.
We expect ESS only to be cost effective in a subgroup of patients.
Our goals in this prospective multicentre study of patient with CRSwNP
scheduled for ESS are:
1. To assess the effectiveness of ESS in addition to drug treatment as compared
to drug treatment alone in adults with
CRSwNP in terms of improving patients* health related quality of life, measured
by the SNOT-22 (primary endpoint), objective
signs of disease, exacerbation of disease, adverse effects of treatment and
associated costs for a period of 12 months.
2. To determine which patient phenotypes within CRSwNP benefit from ESS in
addition to drug treatment as compared to drug
treatment alone.
3. To determine the relation between healthcare resource use, patient costs and
effects of ESS from a societal point of view.
Study design
We will perform a prospective open multi-center randomized controlled trial in
238 adult patients with CRSwNP selected for
ESS according to current medical practice in the Netherlands. Patients will be
randomized to either a) ESS within 6 weeks in
addition to drug treatment, or b) drug treatment alone. Total follow-up will be
24 months. The study will be conducted according
to applicable (inter)national regulatory requirements (WMO, GCP, Declaration of
Helsinki 2004).
The study will be performed in at least 11 hospitals: Academic Medical Center,
VU Medical Centre Amsterdam, Flevo
Ziekenhuis Almere, Spaarne Ziekenhuis Hoofddorp, Kennemer Gasthuis Haarlem,
Ziekenhuis Amstelland Amstelveen,
BovenIJ ziekenhuis Amsterdam, Rijnland Ziekenhuis Leiderdorp en Alphen,
Deventer Ziekenhuis, Westfriesgasthuis Hoorn en
het Tergooi ziekenhuizen. When necessary for inclusion, more hospitals will be
asked to be involved.
Intervention
Eligible patients will be randomly assigned in a 1:1 ratio to one of both
interventions:
1. a surgical strategy consisting of ESS in addition to drug treatment
Those assigned to the surgical strategy will be offered endoscopic sinus
surgery within 6 weeks of randomization. In this study
we mean by endoscopic sinus surgery the surgery as done regularly by
otorhinolaryngologists in the Netherlands. Usually the
extent of the surgery is tailored to the extent of the disease. We do not
standardize surgery. We accept that this introduces a
performance bias (procedures or interventions are not executed in a uniform way
* any one surgeon may do the same
procedure in a different way from day to day, and that is even more true
between different surgeons) but this is closest to usual
care.
2. a medical strategy consisting of drug treatment alone.
Those assigned to the drug treatment strategy will be seen by the
otorhinolaryngologist within 6 weeks of randomization to
evaluate the need for additional medical treatment. Drug treatment can be any
treatment that is normally given in routine
medical practice to treat CRSwNP. We do not standardize drug treatment because
we want to stay closest to standard of care.
Moreover patient*s need for drug treatment vary per patient and over time.
Finally standardization of treatment will impede
inclusion because patients that have a (relative) contraindication for certain
medication (e.g. systemic corticosteroids or certain
antibiotics) cannot be included in the study. This will reduce diversity and
thus the generalization of the results of the study.
The randomization will be website-based, using block randomization and
stratified by study centre. Randomization will be
performed using a dedicated, password protected, SSL-encrypted website.
Study burden and risks
The burden and risks associated with participation consist of:
- questionaires
- nasal endoscopy (5 times)
- smell test (5 times)
- PNIF (5 times)
- Skin prick test (if not done before)
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Bilateral CRSwNP (nasal polyps)
* >17 years
* indication for endoscopic sinus surgery (primary or revision) as judged by their ENT surgeon
Exclusion criteria
* pregnancy
* inability to comply with study protocol,
* systemic diseases affecting the nose (e.g., Wegener*s, granulomatosis, sarcoid, primary ciliary dyskinesia, cystic fibrosis,
* antrochoanal polyps (benign polyps originating from the mucosa of the maxillary sinus).
* inverted papilloma and malignant polyps.
* acute upper or lower respiratory tract infections within 2 weeks before the inclusion visit),
* use of systemic corticosteroids within 4 weeks before the inclusion visit
* need of continuous systemic corticosteroids treatment for other disease than CRSwNP
* systemic diseases preventing participation in the study,
* inability to be operated
* medical or surgical treatments influencing the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48200.018.14 |