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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis (Diagnosis); Surgery
• Intervention / Treatment: Procedure: radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.; Procedure: radical endoscopic sinus surgery (RESS); Procedure: functional endoscopic sinus surgery (FESS)

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: radical endoscopic sinus surgery plus Draf 3 surgery	Procedure: radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.; 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
Experimental: radical endoscopic sinus surgery	Procedure: radical endoscopic sinus surgery (RESS); 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
Experimental: functional endoscopic sinus surgery	Procedure: functional endoscopic sinus surgery (FESS); FESS was performed by Messerklinger technique with middle turbinate preservation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): October 31, 2013
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Polyps; Sinusitis; Nasal Polyps
• Other Study ID Numbers: TR-ES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No