Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy

NCT ID: NCT06117956

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-04-30

Brief Summary

Tonsillar disorders are frequent In both pediatric and adult otolaryngological practice, . Numerous disorders that damage tonsillar tissue necessitate tonsillectomy. Tonsillectomy is typically required for recurrent tonsillitis. (Mani et al., 2019).

According to studies, the mucosa-associated lymphoid tissue (MALT) of the stomach and tonsillar tissue in the Waldeyer's ring are both lymphoid tissues (Ma et al., 2018).

One of the most prevalent and frequent conditions in otorhinolaryngology is chronic tonsillitis, which is mostly brought on by bacterial infection. Chronic tonsillitis attacks can affect not only the tonsillar tissue but also can contribute to the emergence and progression of systemic disorders (Alrayah.,2023).

A gram-negative, urease-producing bacterium called Helicobacter pylori colonizes the mucosa of the digestive tract. It has been linked to gastric malignancies, notably mucosa-associated lymphoid tissue (MALT) lymphoma, as well as gastric ulcers and duodenal ulcers (Kusters et al., 2006).

Conditions

Helicobacter Pylori Infection in Patients With Chronic Tonsillits

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Rapid urease test for h pylori

Tonsillectomy will be done with the dissection method and one tonsil per patient will be collected. A 2 mm gross specimen will be washed with normal saline. The specimen will be placed in a test tube well containing Rapid Urease Enzyme (GASTRO CURE SYSTEM RUT DRY TEST Batch No. A1060).

The initial color will be read at 0 min. Subsequent color changes will be read at 30 min, 6 hours, and 24 hours. Any color change from the initial yellow color to either pink or red will be recorded as positive. Any test that will be remained yellow after 24 hours will be recorded as negative.

Tonsillar tissue samples will be fixed in 10% formalin for 24 h Each slide will be separately evaluated for the presence or absence of Helicobacter-like organisms at a high-power magnification

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

histopathological study for removed tonsillar tissue after tonsillectomy

Eligibility Criteria

Inclusion Criteria

1. Age: 5 to 50 years.

2. Of both sex.

3. Diagnosed with chronic tonsillitis undergoing elective tonsillectomy

Exclusion Criteria

1. Patients on proton pump inhibitor or antibiotics 2 weeks before surgery .

2. Immune-compromised patients.

3. Patients with obstructive sleep apnea candidates for adenotonsillectomy

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Fathy Abdelsattar

Resident- ENT DEPARTEMENT SUGAR COMPANY HOSPITAL

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university Hospital

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

mohamed f fathy, resident

Role: CONTACT

mohamed-fathy-post@med.sohag.edu.eg

01029578650

Mohamed a abdel kader, professor

Role: CONTACT

Facility Contacts

Magdy M Amin, professor

Role: primary

Other Identifiers

soh-Med-23-10-06 MS

Identifier Type: -

Identifier Source: org_study_id