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CompletedNCT05495178Updated Oct 13, 2022

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

An observational study in Hepatobiliary Disease, sponsored by Zagazig University. Completed. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2022-10-13.

Sponsored by Zagazig University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
167
Ages
18 Years to 69 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 167 is above the median of 105 across 247 observational studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
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

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

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,
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
167 participants (actual)
Patient registry
No

Interventions

  • Procedurelaparoscopic restorative proctocolectomy

    laparoscopic restorative proctocolectomy

06

What researchers measure

Primary outcomes

  1. severity of hepatobiliary manifestations after colectomy

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

    Time frame: 4 years

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05495178
Lead sponsor
Zagazig University
Responsible party
Tamer.A.A.M.Habeeb (assistant professour of general and laparoscopic surgery, Zagazig University) — Principal investigator
First posted
Aug 10, 2022
Start date
Jun 1, 2013
Primary completion
Jun 1, 2018
Completion
Jun 1, 2022
Last update
Oct 13, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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