Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

April 18, 2016 updated by: Mattias Block, Sahlgrenska University Hospital, Sweden

Ileal Pouch-anal Anastomosis or Ileo-rectal Anastomosis for Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis?

Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this study was to determine the functional outcome after surgery, frequency of pouchitis, complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.

Study Overview

Status

Completed

Conditions

Detailed Description

Primary sclerosing cholangitis (PSC) is characterised by inflammation and fibrosis of the biliary tree and the condition can lead to end-stage liver disease. PSC is strongly associated with inflammatory bowel disease (IBD), with a prevalence of IBD in PSC as high as 60-84 % in Northern Europe and North America. The majority of patients with IBD and PSC have ulcerative colitis (UC).

Considering all patients with UC, around 30% will ultimately require surgery; the most common indications are acute colitis, chronic refractory disease or colorectal dysplasia. The standard procedure is proctocolectomy and ileal pouch-anal anastomosis (IPAA). However, ileo-rectal anastomosis (IRA) or conventional ileostomy are options. The prognosis after surgery is generally considered good.

Previous studies have shown that the course of colitis in patients with UC/PSC is different from that of patients with UC-only.

In a patient with UC, several aspects have to be considered at counselling before surgery. However, in many aspects, the literature is substantial for patients with UC-only (for example function and quality of life after IPAA) and key information can be safely provided. Conversely, patients with UC/PSC that require colectomy are rare and as a consequence, data on most aspects is sparse (18-20).

The aim of the study was to assess outcome after surgery (IPAA or IRA) in patients with UC/PSC. Focus was on pouch/rectal function, pouchitis, surgical complications and failure. Patients with UC-only were employed as controls.

Study Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 41685
        • Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with UC/PSC vs patients with UC only reconstructed surgically with IPAA or IRA.

Description

Inclusion Criteria:

  • UC
  • PSC
  • IPAA
  • IRA

Exclusion Criteria:

  • non-UC
  • non-PSC
  • no consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
UC/PSC with IPAA
Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileal pouch-anal anastomosis
UC with IPAA
Patients with ulcerative colitis reconstructed with ileal pouch-anal anastomosis.
UC/PSC with IRA
Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileorectal anastomosis.
UC with IRA
Patients with ulcerative colitis reconstructed with ileorectal anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional outcome after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.
Time Frame: Up to six months
Up to six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.
Time Frame: Up to six months.
Up to six months.

Other Outcome Measures

Outcome Measure
Time Frame
Failure after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.
Time Frame: Up to six months.
Up to six months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Lars G Börjesson, Ass Prof, Department of Surgery, Sahlgrenska, Göteborg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (ESTIMATE)

February 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 326-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

PubMed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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