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

Completed

• Conditions: Hepatobiliary Disease

• Registration Number: NCT05495178
• Lead Sponsor: Zagazig University

Brief Summary

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.

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 Timeline

• Study Start: 2013-06-01
• Primary Completion: 2018-06-01
• Study Completion: 2022-06-01
• Study First Submitted: 2022-08-06
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
severity of hepatobiliary manifestations after colectomy	4 years	severity of hepatobiliary manifestations are measured by abdominal ultrasonography,liver biopsy ,CT and MRCP