Identification of Bacterial and Fungal Isolates in Patients with Sinonasal Polyps

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sinonasal Polyps

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Shereen Ahmed Allam; Phone Number: 01008404224; Email: shereenahmed369@gmail.com
• Study Contact Backup: Name: Dr Mohamed Mostafa osman, Professor; Phone Number: 01005267182; Email: Mohamedramadan@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with nasal polyps ,their age between 18 years to 70 years , undergoing FESS

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of bacterial and fungal colanization in patients of chronic rhinosinsitis with nasal polyps	15 days

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Bacterial culture from patients with sinonasal polyi
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: Bacterial in sinonasal polyps

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No