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OpenTrials
Completed

NCT Number: NCT05495178

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

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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,

Treatment and study plan

laparoscopic restorative proctocolectomy

Procedure

laparoscopic restorative proctocolectomy

Primary outcomes

  1. severity of hepatobiliary manifestations after colectomy

    Time frame: 4 years

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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2022
First posted
Aug 10, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.