Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2024-10-23

Brief Summary

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This randomized study compares operative techniques in chronic rhinosinusitis with polyposis (CRSwNP) surgery. It aims to evaluate outcomes in asthma and CRSwNP, safety and costs. The investigators want to see if patients with certain clinical and/or genetic predispositions will benefit from extended surgery. They also aim to find biomarkers for detection and management models for of severe airway inflammation and to further develop markers for progressive disease forms.

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Detailed Description

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Please see study protocol

Conditions

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Sinusitis, Chronic Asthma Nasal Polyps Aspirin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Extended

Extended sinus surgery including all sinuses

Group Type ACTIVE_COMPARATOR

Extended endoscopic sinus surgery

Intervention Type PROCEDURE

ESS of all sinuses

Limited

Limited sinus surgery with partial ethmoidectomy

Group Type ACTIVE_COMPARATOR

Limited endoscopic sinus surgery

Intervention Type PROCEDURE

Partial ethmoidectomy

Interventions

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Extended endoscopic sinus surgery

ESS of all sinuses

Intervention Type PROCEDURE

Limited endoscopic sinus surgery

Partial ethmoidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient not responding to conservative treatment of 3 months of nasal steroid drops
* Nasal polyp score ≥ 4/8
* SNOT-22 ≥ 30
* Lund-Mackay CT score ≥ 14
* One previous endoscopic sinus surgery or at least one peroral corticosteroid course or at least 3 courses of antibiotics within 2 years

Exclusion Criteria

* Age \<18 years, age \> 65 years
* Complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)
* Other diagnosis than CRSwNP (inverted papilloma, antrochoanal polyp etc.)
* Previous external sinus surgery or Draf 3 procedure (or indication for external approaches or Draf 3
* Bleeding diathesis
* Pregnancy/ breastfeeding
* Cystic fibrosis
* Primary ciliary dyskinesia (PCD)
* Sarcoidosis
* Granulomatosis with polyangitis (GPA)
* Eosinophilic granulomatosis with polyangitis (EGPA)
* Immunosupression (diagnosed Spesific Antibody Deficiency (SAD), common variable immunodeficiency (CVI), HIV or use of biologicals/immunosuppressive medication)
* Immunotherapy
* Daily use of systemic corticosteroids
* Communication problems (f.e. neurological/psychiatric disease, language skills)
* Unlikely to comply
* Other severe disease
* Inability to be operated.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No