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

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-01

Study Completion Date

2018-12-31

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.

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Detailed Description

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Conditions

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Chronic Rhinosinusitis (Diagnosis) Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomly assigned 1:1:1 to receive FESS, RESS and RESS plus Draf 3 surgery.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radical endoscopic sinus surgery plus Draf 3 surgery

Group Type EXPERIMENTAL

radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.

Intervention Type PROCEDURE

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

radical endoscopic sinus surgery

Group Type EXPERIMENTAL

radical endoscopic sinus surgery (RESS)

Intervention Type PROCEDURE

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

functional endoscopic sinus surgery

Group Type EXPERIMENTAL

functional endoscopic sinus surgery (FESS)

Intervention Type PROCEDURE

FESS was performed by Messerklinger technique with middle turbinate preservation

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

functional endoscopic sinus surgery (FESS)

FESS was performed by Messerklinger technique with middle turbinate preservation

Intervention Type PROCEDURE

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.