Identification of Bacterial and Fungal Isolates in Patients with Sinonasal Polyps

NCT ID: NCT06637449

Last Updated: 2024-10-15

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

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-15

Study Completion Date

2026-12-01

Brief Summary

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To detect bacterial and fungal growth in patients with sinonasal polyps undergoing FESS

Detailed Description

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Chronic rhinosinusitis with nasal polyps (CRSwNP) is a disease of the nose and paranasal sinuses characterized by mucosal thickening and polyp formation¹ which are inflammatory lesions that project into the nasal airway and are typically bilateral² .Chronic rhinosinsitis with nasal ployps (CRSwNP) affects 0.5% to 4% of the population worldwide. ³ Symptoms include anterior or posterior rhinorrhea, nasal congestion, hyposmia, and/or facial pressure or pain that last for a duration of more than 12 weeks.² The cause of the sinonasal polyps is still unknown but they may be associated with several pathological conditions i.e. infection, allergic fungal sinusitis, allergy and cystic fibrosis ⁴. Many studies were based on detection of bacterial and fungal growth in sinonasal polyps , and found that preoperative bacterial culture showed growth of Staphylococcus coagulase negative (CONS) ,Staphylococcus aureus , gram -ve bacteria i.e. Pseudomonas aeruginosa , Klebsiella pneumoniae , Klebsiella ozenae and Escherichia coli⁴ . From fungi , Aspergillus species were the most commonly recovered isolates ⁵. The initial approach of management was medical treatment . Medical therapy consists of administration of intranasal or systemic steroids. Other medical treatments considered the use of antibiotics, leukotriene modifiers, and avoidance of acetylsalicylic acid. Surgical removal was performed for non-responders to medical management⁶. Functional endoscopic sinus surgery (FESS) is a minimally invasive technique in which sinus air cells and sinus ostia are opened under direct visualization. The goal of this procedure is to restore ventilation and normal functions⁷.

Conditions

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Sinonasal Polyps

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

\- 1. Adult patients (18 and over )

2\. Patients with sinonasal polyposis confirmed with nasal endoscopy and Computed tomography and undergoing FESS

Exclusion Criteria

* 1.Chronic rhinosinsits without nasal polyps 2. Patients below 18 years old and above 70 years old 3. Immunocompromised patient. 4. Recent administration of antibiotics or antifungal medication . 5. Unilateral nasal polyp , granuloma and tumors
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shereen Ahmed Allam Ahmed

Identification of bacterial and fungal isolates in patients with sinonasal polyps

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Shereen Ahmed Allam

Role: CONTACT

01008404224

Dr Mohamed Mostafa osman, Professor

Role: CONTACT

01005267182

References

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Jain S, Das S, Gupta N, Malik JN. Frequency of fungal isolation and antifungal susceptibility pattern of the fungal isolates from nasal polyps of chronic rhinosinusitis patients at a tertiary care centre in north India. Med Mycol. 2013 Feb;51(2):164-9. doi: 10.3109/13693786.2012.694486. Epub 2012 Jul 12.

Reference Type BACKGROUND
PMID: 22783803 (View on PubMed)

Andrews AE, Bryson JM, Rowe-Jones JM. Site of origin of nasal polyps: relevance to pathogenesis and management. Rhinology. 2005 Sep;43(3):180-4.

Reference Type BACKGROUND
PMID: 16218510 (View on PubMed)

Stevens WW, Schleimer RP, Kern RC. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):565-72. doi: 10.1016/j.jaip.2016.04.012.

Reference Type BACKGROUND
PMID: 27393770 (View on PubMed)

Van Zele T, Gevaert P, Holtappels G, Beule A, Wormald PJ, Mayr S, Hens G, Hellings P, Ebbens FA, Fokkens W, Van Cauwenberge P, Bachert C. Oral steroids and doxycycline: two different approaches to treat nasal polyps. J Allergy Clin Immunol. 2010 May;125(5):1069-1076.e4. doi: 10.1016/j.jaci.2010.02.020.

Reference Type BACKGROUND
PMID: 20451040 (View on PubMed)

Other Identifiers

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Bacterial in sinonasal polyps

Identifier Type: -

Identifier Source: org_study_id

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