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

Hepatobiliary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495178
• Other study ID #: hepatobiliary manifestations
• Status: Completed
• Start date: June 1, 2013
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2018
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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,

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Digestive System Diseases
• Hepatobiliary Disease
• Liver Diseases

Intervention

Procedure:
• laparoscopic restorative proctocolectomy
laparoscopic restorative proctocolectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of hepatobiliary manifestations after colectomy	severity of hepatobiliary manifestations are measured by abdominal ultrasonography,liver biopsy ,CT and MRCP	4 years