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

October 7, 2022 updated by: Tamer.A.A.M.Habeeb, Zagazig University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A prospective observational study was planned in our university hospitals' Surgical, internal and hepatology units on 167 patients with hepatobiliary manifestations in patients underwent one stage elective LRP for ulcerative colitis from June 2013 to June 2018. Inclusion criteria were all 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.indication for surgery in patients with UC was indicated according to ECCO guidelines on therapeutics in ulcerative colitis

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severity of hepatobiliary manifestations after colectomy
Time Frame: 4 years
severity of hepatobiliary manifestations are measured by abdominal ultrasonography,liver biopsy ,CT and MRCP
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

August 6, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hepatobiliary manifestations

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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