A Study of Different Endoscopic Surgery Procedures in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Study Overview
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Brief Summary
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CRS remains a common challenging clinical entity due to variable phenotypes with different underlying mechanisms that lead to persistence or recurrence polyps. The eosinophils dominant inflammation was considered as a major pathological hallmark and challenges of CRS with nasal polyps (CRSwNP). Differentiate surgical approaches towards eosinophilic CRSwNP (eCRSwNP) should be addressed on the basis of the inflammatory endotypes. eCRSwNP has been recognized as the most easily relapsed type of CRS, and the combination of asthma increases the difficulty of treatment. Till now there is no recognized surgical strategy for eCRSwNP with asthma.

Official Title
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Long-term Outcomes of Radical Endoscopic Sinus Surgery Plus Draf 3 Procedure in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps and Asthma: A 9-year Prospective Study

Conditions
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Chronic Rhinosinusitis (Diagnosis), Surgery

Intervention / Treatment
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* Procedure: radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.
* Procedure: radical endoscopic sinus surgery (RESS)
* Procedure: functional endoscopic sinus surgery (FESS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of CRSwNP was based on the standard criteria issued in the European Position Paper on Rhinosinusitis and Nasal Polyps guidelines. Participants had at least 1 previous sinus surgery underwent FESS (middle turbinate (MT) preserved), good gasification of frontal sinus and with concomitant asthma. The diagnosis of asthma was confirmed by a chest physician according to Global Initiative for Asthma (GINA) guidelines. Polyp biopsy was undertaken 1 week before surgery and the eCRSwNP was confirmed by the number of eosinophils exceeded 10% of total infiltrating inflammatory cells in the polyp tissue through the evaluation by using hematoxylin and eosin (H&E) staining. Exclusion Criteria: Patients were excluded if they had unilateral disease, allergic fungal rhinosinusitis, antrochoanal polyps, or cysts.

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 71 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomly assigned 1:1:1 to receive FESS, RESS and RESS plus Draf 3 surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radical endoscopic sinus surgery plus Draf 3 surgery<br> | Procedure: radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.<br>* The procedure of RESS was completed as described in full-house FESS (FHF) approach, involving complete removal of all nasal polyps along with a full maxillary antrostomy, total ethmoidectomy, wide sphenoidotomy, and a Draf 2A frontal sinusotomy. Moreover the bilateral inferior two-thirds of MTs were meanwhile resected. The technique for the Draf 3 frontal drillout procedure was described in detail in previous publications with resection of the superior nasal septum, central frontal sinus floor, and frontal beak region, resulting in a widely patent, oval-shaped, common frontal sinus neo-ostium<br>|
| Experimental: radical endoscopic sinus surgery<br> | Procedure: radical endoscopic sinus surgery (RESS)<br>* The procedure of RESS was completed as described in full-house FESS (FHF) approach, involving complete removal of all nasal polyps along with a full maxillary antrostomy, total ethmoidectomy, wide sphenoidotomy, and a Draf 2A frontal sinusotomy. Moreover the bilateral inferior two-thirds of MTs were meanwhile resected<br>|
| Experimental: functional endoscopic sinus surgery<br> | Procedure: functional endoscopic sinus surgery (FESS)<br>* FESS was performed by Messerklinger technique with middle turbinate preservation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | Recurrence was defined if the patient had symptoms of chronic rhinosinusitis after surgery, and nasal endoscopy found nasal polyps recurrence, obvious edema of mucosa, or purulent secretion, and above of symptoms or physical signs existed, which can't be alleviated by maximum medicine treatment at least 1 month | 1 year after surgery | 
| recurrence | Recurrence was defined if the patient had symptoms of chronic rhinosinusitis after surgery, and nasal endoscopy found nasal polyps recurrence, obvious edema of mucosa, or purulent secretion, and above of symptoms or physical signs existed, which can't be alleviated by maximum medicine treatment at least 1 month | 3 years after surgery | 
| recurrence | Recurrence was defined if the patient had symptoms of chronic rhinosinusitis after surgery, and nasal endoscopy found nasal polyps recurrence, obvious edema of mucosa, or purulent secretion, and above of symptoms or physical signs existed, which can't be alleviated by maximum medicine treatment at least 1 month | 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale of 4 major clinical symptoms | Subjective symptoms were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable. Four major symptoms include nasal congestion, rhinorrhea, loss of smell, and headache and/or facial pain. | at baseline, and 1 year, 3years, 5 years after surgery | 
| Sinus-specific quality of life (QoL) | Sinus-specific quality of life (QoL) was assessed using the 22-item Sinonasal Outcome Test (SNOT-22) | at baseline, and 1 year, 3years, 5 years after surgery | 
| Postoperatively endoscopic results | Postoperatively endoscopic results were scored according to the Lund-Kennedy system, with the assessment of edema, nasal discharge, scarring, and crusting | at baseline, and 1 year, 3years, 5 years after surgery |