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临床试验/NCT05495178
NCT05495178已完成不适用

Hepatobiliary Manifestations Following Two-Stages Elective Laparoscopic Restorative Proctocolectomy for Patients With Ulcerative Colitis. A Prospective Observational Study.

Zagazig University0 个研究点目标入组 167 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
167
主要终点
severity of hepatobiliary manifestations after colectomy

研究概览

简要总结

Several studies using different methodological approach have revealed incomplete, old and conflicting data on the course of hepatobiliary manifestations after surgery. authors conducted a prospective observational study to evaluate the role of LRP on the course of hepatobiliary manifestations for a better knowledge of these manifestations that is necessary to improve their management.also, to evaluate the role of surgery on prevention of liver damage from progression of the disease.

详细描述

Inflammatory bowel disease (IBD) prevalence is expected to reach 1% of the population in many regions over the next decade. despite the fact that the primary clinical manifestations of IBD are centred in the gastrointestinal tract, 25-40% of IBD patients develop at least one extraintestinal manifestation (EIM).

Hepatobiliary manifestations constitute one of the most common EIMs in IBD . Hepatobiliary manifestations are much more commonly associated with ulcerative colitis (UC) and include primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH), fatty liver, cholelithiasis, primary biliary cholangitis, portal vein thrombosis, and hepatic abscess.

Most UC patients can be managed medically, but a minority requires proctocolectomy. Two-stage laparoscopic proctocolectomy (LPC) with ileal pouch-anal anastomosis (IPAA) is a cure for colitis, but its effect on hepatobiliary diseases is controversial.

研究设计

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

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients between 18-69 years,
  • both sex diagnosed as ulcerative colitis with at least one hepatobiliary manifestation
  • underwent laparoscopic restorative proctocolectomy with ileal pouch anal anastomosis
  • with or without gallstones.

排除标准

  • age<18 years or > 69 years,
  • alcohol abuse,
  • pregnancy,
  • severe heart failure or type II diabetes mellitus (defined as established diagnosis, HbA1c > 6.4%, non-fasting glucose level > 180 mg/dL, or on antidiabetic medication),
  • development of complications or death related to the operation of LRP ,
  • liver toxicity of IBD-related medications.,
  • chronic viral hepatitis,
  • haemochromatosis,
  • Wilson's disease,

结局指标

主要结局

severity of hepatobiliary manifestations after colectomy

时间窗: 4 years

severity of hepatobiliary manifestations are measured by abdominal ultrasonography,liver biopsy ,CT and MRCP

次要结局

未报告次要终点

研究者

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

Tamer.A.A.M.Habeeb

assistant professour of general and laparoscopic surgery

Zagazig University

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