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

NCT ID: NCT05495178

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-01
• Study Completion Date: 2022-06-01

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.

Conditions

Hepatobiliary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

laparoscopic restorative proctocolectomy

laparoscopic restorative proctocolectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tamer.A.A.M.Habeeb

assistant professour of general and laparoscopic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

hepatobiliary manifestations

Identifier Type: -

Identifier Source: org_study_id