To determine the influence of the extent of surgery on disease control in CRSwNP patients
ID
Source
Brief title
Condition
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the difference in the disease-specific patient reported
outcome measurement *SNOT-22* scores between the limited and extended groups 1
and 2 years after surgery.
Secondary outcome
Furthermore, differences in (additional) medication use, reinterventions,
objective and subjective measures of control of CRSwNP and of asthma, safety
indicators and medical costs (both direct and indirect) will be compared in
order to better counsel patients for either limited or extended surgical
procedures
Background summary
Approximately 4% of the population suffers from chronic rhinosinusitis with
nasal polyps (CRSwNP). This disease has major impact on quality of life.
Treatment consists of medication (mainly local and oral corticosteroids) and,
in uncontrolled disease, endoscopic sinus surgery (ESS). More severe CRSwNP
cases, for example those with comorbid asthma or aspirin-exacerbated disease
(AERD) often need multiple surgeries in the course of their life. However, the
influence of the extent of surgery (limited or extended ESS) on the control of
disease has not yet been adequately elucidated.
Study objective
To determine the influence of the extent of surgery on disease control in
CRSwNP patients
Study design
randomized controlled multicenter study
Intervention
subjects are randomized between limited or extended ESS
Study burden and risks
the burden of participating in this study is mainly investing extra time,
primarily from filling in questionnaires every three months (SNOT-22, 15D,
WPAI:GH, iPCQ, iMCQ, ACT, mini-AQLQ). Most investigations (e.g., nasal
endoscopy) as well as the initial surgery are standard of care. Also, the
follow-up visits themselves are on a standard three-month interval. Additional
investigations are non-invasive and take little time (test for nasal patency,
smell test, lung function test). Overall, the burden is estimated to be 8 extra
hours over the course of 2 years of follow-up. As such, the risks associated
with participation are estimated to be negligible.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- 18-65 years of age
- having chronic rhinosinusitis with nasal polyps with an indication for surgery
- 1 oral corticosteroid course / 3 antibiotic courses in the past 2 years; or
at least 1 previous sinus surgery
Exclusion criteria
- complications of chronic rhinosinusitis warranting surgery
- indication for or previous extensive surgery (external approaches or draf III)
- bleeding diathesis
- pregnancy / breast feeding
- underlying diseases such as CF, PCD, GPA, eGPA, sarcoidosis, HIV, CVID
- use of immunosuppressive or immunomodulatory medication (biologicals, daily
oral corticosteroids)
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 | NL63136.018.20 |