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

Primary Purpose

Chronic Rhinosinusitis (Diagnosis), Surgery

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.
radical endoscopic sinus surgery (RESS)
functional endoscopic sinus surgery (FESS)
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis (Diagnosis)

Eligibility Criteria

24 Years - 71 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    radical endoscopic sinus surgery plus Draf 3 surgery

    radical endoscopic sinus surgery

    functional endoscopic sinus surgery

    Arm Description

    Outcomes

    Primary Outcome Measures

    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
    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
    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

    Secondary Outcome Measures

    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.
    Sinus-specific quality of life (QoL)
    Sinus-specific quality of life (QoL) was assessed using the 22-item Sinonasal Outcome Test (SNOT-22)
    Postoperatively endoscopic results
    Postoperatively endoscopic results were scored according to the Lund-Kennedy system, with the assessment of edema, nasal discharge, scarring, and crusting

    Full Information

    First Posted
    March 12, 2019
    Last Updated
    March 14, 2019
    Sponsor
    Beijing Tongren Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03878355
    Brief Title
    A Study of Different Endoscopic Surgery Procedures in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2010 (Actual)
    Primary Completion Date
    October 31, 2013 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Tongren Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Rhinosinusitis (Diagnosis), Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients were randomly assigned 1:1:1 to receive FESS, RESS and RESS plus Draf 3 surgery.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    radical endoscopic sinus surgery plus Draf 3 surgery
    Arm Type
    Experimental
    Arm Title
    radical endoscopic sinus surgery
    Arm Type
    Experimental
    Arm Title
    functional endoscopic sinus surgery
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.
    Intervention Description
    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
    Intervention Name(s)
    radical endoscopic sinus surgery (RESS)
    Intervention Description
    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
    Intervention Name(s)
    functional endoscopic sinus surgery (FESS)
    Intervention Description
    FESS was performed by Messerklinger technique with middle turbinate preservation
    Primary Outcome Measure Information:
    Title
    recurrence
    Description
    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
    Time Frame
    1 year after surgery
    Title
    recurrence
    Description
    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
    Time Frame
    3 years after surgery
    Title
    recurrence
    Description
    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
    Time Frame
    5 years after surgery
    Secondary Outcome Measure Information:
    Title
    Visual analogue scale of 4 major clinical symptoms
    Description
    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.
    Time Frame
    at baseline, and 1 year, 3years, 5 years after surgery
    Title
    Sinus-specific quality of life (QoL)
    Description
    Sinus-specific quality of life (QoL) was assessed using the 22-item Sinonasal Outcome Test (SNOT-22)
    Time Frame
    at baseline, and 1 year, 3years, 5 years after surgery
    Title
    Postoperatively endoscopic results
    Description
    Postoperatively endoscopic results were scored according to the Lund-Kennedy system, with the assessment of edema, nasal discharge, scarring, and crusting
    Time Frame
    at baseline, and 1 year, 3years, 5 years after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    24 Years
    Maximum Age & Unit of Time
    71 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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