跳至主要内容
临床试验/NCT06117956
NCT06117956招募中不适用

Helicobacter Pylori in Patients With Chronic Tonsillits Prepared for Tonsillectomy

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
positive or negative h pylori infection in tonsillar tissue after tonsillectomy

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
5 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 5 to 50 years.
  • Of both sex.
  • Diagnosed with chronic tonsillitis undergoing elective tonsillectomy

排除标准

  • Patients on proton pump inhibitor or antibiotics 2 weeks before surgery .
  • Immune-compromised patients.
  • Patients with obstructive sleep apnea candidates for adenotonsillectomy

结局指标

主要结局

positive or negative h pylori infection in tonsillar tissue after tonsillectomy

时间窗: 6 months

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. No readings will be taken after 24 hours. Histopathology: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Fathy Abdelsattar

Resident- ENT DEPARTEMENT SUGAR COMPANY HOSPITAL

Sohag University

研究点 (1)

Loading locations...

相似试验