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

NCT03878355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-03-18

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Rhinosinusitis (Diagnosis)
  • Surgery

Interventions

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

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

PROCEDURE

functional endoscopic sinus surgery (FESS)

FESS was performed by Messerklinger technique with middle turbinate preservation

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2013-10-31
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878355 on ClinicalTrials.gov