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临床试验/NCT06143163
NCT06143163尚未招募不适用

Clinical Outcome of Treatment of Ulcerative Colitis in Adult.

Assiut University0 个研究点目标入组 162 人开始时间: 2024年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
162
主要终点
- Characterize the response to current medical therapy in adult with Ulcerative colitis

研究概览

简要总结

  1. characterize the response to current medical therapy in adult with ulcerative colitis .
  2. Detect prognostic factors of response of biological therapy in adult with ulcerative colitis

详细描述

Ulcerative colitis is an idiopathic inflammatory condition of the colon which results in diffuse friability and superficial erosions on the colonic wall associated with bleeding. It is the most common form of inflammatory bowel disease worldwide. It characteristically involves inflammation restricted to the mucosa and submucosa of the colon. Typically, the disease starts in the rectum and extends proximally in a continuous manner. In the United States, the disease accounts for a quarter-million provider visits annually, and medical costs directly related to the disease are estimated to exceed four billion dollars annually.Ulcerative has no cure and is a lifelong disorder with a significant impact on both physical and mental health. The specific cause of inflammatory bowel disease is not known. There seems to be a primary genetic component since the most important independent risk factor is a family history of the disease (8% to 14% of patients). A first-degree relative of a patient with ulcerative colitis has a four times higher risk of developing the disease. Although there is little evidence to support this, it has been postulated that alterations in the composition of the gut microbiota and defects in mucosal immunity could lead to ulcerative colitis. Autoimmunity may also play an important role in the etiology of ulcerative colitis.Diagnosis of ulcerative colitis is made clinically with supportive findings on endoscopy, biopsy, and by negative stool examination for infectious causes. Because colonic infection can produce clinical findings indistinguishable from idiopathic ulcerative colitis, microbiologic studies for bacterial infection and parasitic infestation should be included in the initial evaluation.Treatment choice for patients with ulcerative colitis is based on both the extent of the disease and the severity. The prognosis during the first decade after diagnosis is often generally good, and most patients go into remission. Rectal application of medical therapy, via suppository or enema, is usually appropriate for isolated distal disease (proctitis); however, a rectal application is usually used in combination with systemic therapy to help target the distal colon and therefore decrease tenesmus.Ulcerative colitis has no cure and despite treatment, many continue to have increased bouts of stool frequency. An increase in mortality is usually seen in elderly patients, those with complications like infection, shock, anemia, and those who require repeated surgical interventions. Data show that when the disease involves the muscularis propria, it can lead to bowel dysmotility, necrosis, and gangrene. A certain number of patients also develop toxic megacolon with poor outcomes. It is estimated that about 5% of patients will develop colorectal cancer over time. The risk of colon cancer is higher in patients with pancolitis and in patients whose disease started before the age of 15. Overall, the quality of life in patients with ulcerative colitis is poor.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Patients above age of 18 years old previously diagnosed by colonscopy and biobsy with ulcerative colitis attending IBD clinic El-Raghy liver Hospital

排除标准

  • patients younger than 18 years old .
  • patients known to have chronic liver disease.
  • patient known to have renal disease.
  • Patients diagnosed with cardiac disease.

结局指标

主要结局

- Characterize the response to current medical therapy in adult with Ulcerative colitis

时间窗: Baseline

The clinical course of the disease Will be assessed after 3 months of treatment according to guidelines as follow 1. clinical assessment as regard symptoms as rectal bleeding, diarrhea, abdominal pain, stool frequency guided by mayo score. 2. laboratory assessment including: ESR,CRP,CBC,fecalcalprotectin. 3. Endoscopic evaluation regarding the mayo score. 4. Histopathological assessment to evaluate the stage of activity of the disease.

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

Kholoud Mohamed Hassan

Dr kholoud Mohamed Hassan

Assiut University

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