Back to resultsThe Effect of Modified Radical Endoscopic Sinus Surgery on Eosinopilic Chronic Rhinosinusitus With Nasal Polyps (EMRESSECRS)
Primary Purpose
Chronic Sinusitis, Endoscopic Sinus Surgery, Nasal Polyps
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified radical endoscopic sinus surgery
functional endoscopic sinus surgery
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sinusitis focused on measuring eosinophilic chronic rhinosinusitus with nasal polyps., endoscopic sinus surgery, Nasal Polyps
Eligibility Criteria
Inclusion Criteria:
- CRSwNP is diagnosed according to EPOS clinical guidelines and met surgical requirements, the blood eosinophil count was greater than 0.22;
- Subjects/legal authorized representatives must understand the purpose and procedures of the study and voluntarily sign the informed consent, voluntarily participate in the study and comply with the study regulations, understand and comply with follow-up plan, and can correctly record the scale score, the administration frequency, accompanying drug use and adverse events, etc;
- The examinee must be 18-65 years old, male or non pregnant female, limited to Chinese;
- During the treatment and follow-up period, female subjects have no pregnancy and lactation plans;
- The subjects did not participate in other clinical trials in the past three months and agreed not to participate in other clinical trials before reaching the end point of this trial;
- Patients accompanying asthma must use their regular asthma treatment steadily in the past 6 weeks;
Exclusion Criteria:
- Women must not be pregnant, or breast-feeding;
- Subjects with cystic fibrosis, congenital ciliary dyskinesia, fungal sinusitis, systemic vasculitis and granulomatous disease, tumor, and immunodeficiency are exclued;
- Subjects accpted nasal endoscopic surgery within 6 months are exclued;
- Subjects with an upper respiratory tract infection within 4 weeks of entering the study are excluded;
- Subjects with serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, or respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects safety are excluded, such as glaucoma and tuberculosis;
- Currently participating in other clinical studies or in other clinical investigators within 30 days, or staff directly involved in this study;
- Subjects with emotional or mental problems are excluded;
- Subjects must not have received immunotherapy within the previous 3 months;
- Subjects unsuitable for inclusion based on judgement of researchers are excluded;
Sites / Locations
- Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Modified radical endoscopic sinus surgery(MRESS)
Functional endoscopic sinus surgery (FESS)
Arm Description
The experimental group intends to adopt a modified radical endoscopic sinus surger to remove the mucosa including ethmoid sinus and maxillary sinus, as well as a completly middle turbinate resection to achieve a radical cure of ethmoid sinus. Antrostomies of frontal and sphenoid sinuses were then performed with meticulous operation and preserve the mucosa intactly.
FESS was performed by Messerklinger technique, operation procedures including full maxillary antrostomy, ethmoidectomy, sphenoidotomy and frontal sinusotomy, but with the middle turbinate preservation.
Outcomes
Primary Outcome Measures
Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention
The SNOT-22 is a validated questionnaire that was used to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life.
Secondary Outcome Measures
Revision surgery rate
The rate of reoperation in each group after surgery
Symptom duration
The time of duration of major symptoms of postoperative patients
Postoperative medication
The duration and dose of postoperative medication needed to relieve symptoms
Recurrence time
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
Change from baseline at months 1, 3, 6 and 12 in visual analogue scale (VAS) after surgical intervention
The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters (cm) VAS the answer to the question, "How troublesome are your symptoms of your rhinosinusitis?" The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome.
Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention
Endoscopic result is scored according to Lund-Kennedy system, with the assessment of nasal polyp (NP), edema, nasal discharge, scarring and crusting. Items including edema, nasal discharge, scarring and crusting score 0 for no problem, 1 for mild abnormalities and 2 for severe abnormalities. NP score is graded and based on NP size recorded as the sum of the right and left nostril scores with a range of 0-8; higher scores indicate worse status. Individual score ranges from 0 (no polyps) to 4 (large polyps causing almost complete congestion/ obstruction of the inferior meatus) within each nostril.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04852562
Brief Title
The Effect of Modified Radical Endoscopic Sinus Surgery on Eosinopilic Chronic Rhinosinusitus With Nasal Polyps
Acronym
EMRESSECRS
Official Title
The Effect of Modified Radical Endoscopic Sinus Surgery on Chinese Patients With Eosinopilic Nasal Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2020 (Actual)
Primary Completion Date
December 6, 2023 (Anticipated)
Study Completion Date
December 6, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zheng Liu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Functional endoscopic sinus surgery (FESS) is the pimary surgical treatment of CRS, characterized with the preservation of nasal structure and function.But the control of disease by surgery has been unsatisfactory. Recent studies have shown that patients with recurrent CRSwNP (usually with severe eosinophilic inflammation), more radical surgery may be more effective. The purpose of this prospective and randomized study is to determine the effect of endoscopic sinus surgery for extensive mucosal removal in patients with eosinophilic chronic rhinosinusitus with nasal polyps.
Detailed Description
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disorder that causes various symptoms including nasal obstruction, rhinorrhea, olfactory dysfunction, facial pain, and headache. Patients with significant eosinophilic inflammation usually accompanied with a higher recurrence rate and more severe clinical symptoms. Endoscopic sinus surgery (ESS) is recommended to patients who do not response well to conservative treatments. A retrospective study showed that postoperative polyp recurrence rate of patients with severe eosinophilic inflammation was significantly reduced by rebooting sinus mucosa. In this study, the experimental group intends to adopt a modified radical surger to remove the mucosa including ethmoid sinus and maxillary sinus, as well as a completly middle turbinate resection to achieve a extensive treatment of ethmoid sinus. Antrostomies of frontal and sphenoid sinuses were then performed with meticulous operation and preserve the mucosa intactly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis, Endoscopic Sinus Surgery, Nasal Polyps
Keywords
eosinophilic chronic rhinosinusitus with nasal polyps., endoscopic sinus surgery, Nasal Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modified radical endoscopic sinus surgery(MRESS)
Arm Type
Experimental
Arm Description
The experimental group intends to adopt a modified radical endoscopic sinus surger to remove the mucosa including ethmoid sinus and maxillary sinus, as well as a completly middle turbinate resection to achieve a radical cure of ethmoid sinus. Antrostomies of frontal and sphenoid sinuses were then performed with meticulous operation and preserve the mucosa intactly.
Arm Title
Functional endoscopic sinus surgery (FESS)
Arm Type
Experimental
Arm Description
FESS was performed by Messerklinger technique, operation procedures including full maxillary antrostomy, ethmoidectomy, sphenoidotomy and frontal sinusotomy, but with the middle turbinate preservation.
Intervention Type
Procedure
Intervention Name(s)
Modified radical endoscopic sinus surgery
Other Intervention Name(s)
MRESS
Intervention Description
Modified radical endoscopic sinus surgery was performed to remove the mucosa including ethmoid sinus and maxillary sinus, as well as a completly middle turbinate.
Intervention Type
Procedure
Intervention Name(s)
functional endoscopic sinus surgery
Other Intervention Name(s)
FESS
Intervention Description
Full maxillary antrostomy, ethmoidectomy, sphenoidotomy and frontal sinusotomy, but with the middle turbinate preservation.
Primary Outcome Measure Information:
Title
Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention
Description
The SNOT-22 is a validated questionnaire that was used to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life.
Time Frame
1month, 3month, 6month, 12month
Secondary Outcome Measure Information:
Title
Revision surgery rate
Description
The rate of reoperation in each group after surgery
Time Frame
12month
Title
Symptom duration
Description
The time of duration of major symptoms of postoperative patients
Time Frame
1month, 3month, 6month, 12month
Title
Postoperative medication
Description
The duration and dose of postoperative medication needed to relieve symptoms
Time Frame
1month, 3month, 6month, 12month
Title
Recurrence time
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
1month, 3month, 6month, 12month
Title
Change from baseline at months 1, 3, 6 and 12 in visual analogue scale (VAS) after surgical intervention
Description
The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters (cm) VAS the answer to the question, "How troublesome are your symptoms of your rhinosinusitis?" The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome.
Time Frame
1month, 3month, 6month, 12month
Title
Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention
Description
Endoscopic result is scored according to Lund-Kennedy system, with the assessment of nasal polyp (NP), edema, nasal discharge, scarring and crusting. Items including edema, nasal discharge, scarring and crusting score 0 for no problem, 1 for mild abnormalities and 2 for severe abnormalities. NP score is graded and based on NP size recorded as the sum of the right and left nostril scores with a range of 0-8; higher scores indicate worse status. Individual score ranges from 0 (no polyps) to 4 (large polyps causing almost complete congestion/ obstruction of the inferior meatus) within each nostril.
Time Frame
1month, 3month, 6month, 12month
Other Pre-specified Outcome Measures:
Title
Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid
Description
Investigate the change of inflammation molecular biomarkers using sample of nasal lavage fluid or mucosal lesion tissue. Biomarkers including interleukin 9, monocyte chemoattractant protein-1, macrophage inflammatory protein-1β, macrophage inflammatory protein-1α, chemokine (C-C motif ) ligand 17 and IgE in nasal lavage fluid at months 1, 3, 6 and 12 were detected to compare the changes of molecular indices relative to baseline.
Time Frame
1month, 3month, 6month, 12month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CRSwNP is diagnosed according to EPOS clinical guidelines and met surgical requirements, the blood eosinophil count was greater than 0.22;
Subjects/legal authorized representatives must understand the purpose and procedures of the study and voluntarily sign the informed consent, voluntarily participate in the study and comply with the study regulations, understand and comply with follow-up plan, and can correctly record the scale score, the administration frequency, accompanying drug use and adverse events, etc;
The examinee must be 18-65 years old, male or non pregnant female, limited to Chinese;
During the treatment and follow-up period, female subjects have no pregnancy and lactation plans;
The subjects did not participate in other clinical trials in the past three months and agreed not to participate in other clinical trials before reaching the end point of this trial;
Patients accompanying asthma must use their regular asthma treatment steadily in the past 6 weeks;
Exclusion Criteria:
Women must not be pregnant, or breast-feeding;
Subjects with cystic fibrosis, congenital ciliary dyskinesia, fungal sinusitis, systemic vasculitis and granulomatous disease, tumor, and immunodeficiency are exclued;
Subjects accpted nasal endoscopic surgery within 6 months are exclued;
Subjects with an upper respiratory tract infection within 4 weeks of entering the study are excluded;
Subjects with serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, or respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects safety are excluded, such as glaucoma and tuberculosis;
Currently participating in other clinical studies or in other clinical investigators within 30 days, or staff directly involved in this study;
Subjects with emotional or mental problems are excluded;
Subjects must not have received immunotherapy within the previous 3 months;
Subjects unsuitable for inclusion based on judgement of researchers are excluded;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Liu, Doctor
Phone
86 027 83663807
Email
zhengliuent@hotmail.com
Facility Information:
Facility Name
Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Liu, Doctor
Phone
86 027 83663807
Email
zhengliuent@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ming Zeng, Doctor
Phone
86 027 83663809
Email
zmsx77@163.com
First Name & Middle Initial & Last Name & Degree
Zheng Liu, Doctor
First Name & Middle Initial & Last Name & Degree
Heng Wang, Doctor
First Name & Middle Initial & Last Name & Degree
Ming Zeng, Doctor
12. IPD Sharing Statement
Learn more about this trial
The Effect of Modified Radical Endoscopic Sinus Surgery on Eosinopilic Chronic Rhinosinusitus With Nasal Polyps
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