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

NCT05495178 | Completed

• 1 other identifier: hepatobiliary manifestations
• Study Type: observational
• Target: 167
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatobiliary Disease

Outcome Measures

Primary Outcomes (1)

• severity of hepatobiliary manifestations after colectomy

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

  4 years

Interventions

laparoscopic restorative proctocolectomy PROCEDURE

laparoscopic restorative proctocolectomy

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professour of general and laparoscopic surgery

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 10, 2022
• Study Start: June 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10