Effect of Postoperative Additive Systemic Steroids in CRSwNP
- Conditions
- Sinusitis, Chronic
- Interventions
- Drug: Systemic Steroid (Prednisolone)Other: Placebo
- Registration Number
- NCT04915456
- Brief Summary
This study investigate the additive effect of systemic postoperative steroids in patients with chronic rhinosinusitis (CRSwNP). All patients receive a functional endoscopic sinus surgery (FESS) followed by topical steroid spray for 3 months. Postoperatively, patients will be randomized to either an additional systemic steroid or a placebo for 1 month. Patients will be followed for 2 years. Effect on Nasal Polyp score (NPS), Lund-Kennedy-Score (LKS), recurrence rates, smell scores, Rhinosinusitis Disability Index (RSDI), Short-Form 36 (SF-36) and mucus/serum biomarkers will be measured.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- CRSwNP
- refractory to medical therapy
- no previous sinus surgery
- Lund-Kennedy-Score ≥ 1
- Lund-Mackay-Score ≥ 10
- ciliary impairment
- autoimmune disease
- cystic fibrosis
- immunodeficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Systemic steroid (Prednisolone) Systemic Steroid (Prednisolone) Prednisolone 50mg (tapered down until postoperative day (POD) 14, then 5mg for 14 days), tablets Placebo Placebo Lactose monohydrate, tablets
- Primary Outcome Measures
Name Time Method Nasal Polyp Score (NPS) first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) Each nostril will be assessed separately. The highest score will be graded. Each nostril will be scored from 0-4 (0=no polyps, 1=polyps confined to the middle meatus, 3=polyps extending beyond middle meatus, 4=large polyps causing almost complete nasal obstruction)
- Secondary Outcome Measures
Name Time Method Lund-Kennedy-Score (LKS) first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) Lund-Kennedy-Scores range from 0-12. Scoring includes the assessment of polyps (0=no polyps, 1=middle meatus, 2= beyond middle meatus), discharge (0=no discharge, 1=thin discharge, 2=edema/scarring/crusting (0=absent, 1=mild, 2=severe)
Smell Scores first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) Sniffing Sticks Screening-16 test ("forced choice"), graded from 0-16 with a higher score indicating a better sense of smell, anosmia is defined as a score ≤7
Sinonasal Symptom Score first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) nasal congestion, anterior rhinorrhea, posterior rhinorrhea, sneezing, pruritus in the nose, tearing, ear pressure, throat pain, facial pain or pressure, headache, numbness in cheek/lips/teeth. All graded from 0-3 (0=no problems, 1=mild problems, 2= moderate problems, 3= severe problems)
Mucus and serum biomarker levels first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) Pappalysin-1, Cystatin-SN, Periostin, SerpinE1, SerpinF2 (measured in pg/ml)
RSDI (Rhinosinusitis Disability Index) first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) validated 30-item Likert scale instrument containing three subscales that assess the impact of sinusitis on physical, functional, and emotional domains. The Score ranges from 0-120. Higher total and subscale RSDI scores represent a worse impact of sinus disease.
SF-36 (Short Form-36) first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) There is no single overall score for the SF-36, instead, it generates 8 subscales and two summary scores. The subscales are: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role-limitations due to emotional problems, mental health. The scoring ranges from 0-100. Higher total and subscale scores represent a better health situation.
Recurrence rates first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months) Increase of NPS per side ≥ 2 within 2 year follow-up