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临床试验/NCT06881238
NCT06881238招募中不适用

The Impact of Hepatitis B Virus Infection on the Clinical Course of Inflammatory Bowel Disease in Egyptian Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
162
试验地点
1
主要终点
Number of patients with severe IBD measured by Truelove-Witts severity index

研究概览

简要总结

The goal of this observational retrospective study is to assess the impact of hepatitis B virus (HBV) infection on the clinical course and outcomes of inflammatory bowel disease (IBD) in Egyptian patients.

Researchers will compare the IBD extent, location, severity, and behavior between IBD patients with and without HBV infection.

Participants will be subjected to history-taking (history of hospital admission and disease flare, surgical history, medication history, follow-up duration, and mortality), clinical examination, laboratory investigations, abdominal ultrasonography, and endoscopic examination.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients older than 18 years.
  • Patients with IBD are diagnosed by clinical, radiological, endoscopic, and histological criteria.

排除标准

  • Patients aged < 18 years
  • Unwilling to participate in our study

结局指标

主要结局

Number of patients with severe IBD measured by Truelove-Witts severity index

时间窗: through study completion, an average of 6 month

comparing IBD extent, location, and behavior using Montreal classification, Truelove-Witts severity index between patients with and without HBV infection

Hospital admission rates in IBD patients

时间窗: through study completion, an average of 6 month

comparing IBD hospital admission rates between patients with and without HBV infection

number of IBD patients undergoing surgical treatment

时间窗: through study completion, an average of 6 month

comparing surgical treatment rates (intestinal resection in CD patients and total proctocolectomy in UC patients) for IBD between patients with and without HBV infection

次要结局

  • Disease flares rates in IBD patients(through study completion, an average of 6 months)
  • mortality rates in IBD patients(through study completion, an average of 6 months)

研究者

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

Rania Mamdouh Elkafoury

Lecturer of Tropical Medicine

Tanta University

研究点 (1)

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