Skip to main content
OpenTrials
Completed

NCT Number: NCT01798953

Surgical Reconstruction in Ulcerative Colitis With 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital

Gothenburg, Göteborg, 41685, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • UC
  • PSC
  • IPAA
  • IRA

Exclusion criteria

  • non-UC
  • non-PSC
  • no consent

Treatment and study plan

Primary outcomes

  1. Functional outcome after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.

    Time frame: Up to six months

Secondary outcomes

  1. Complications after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.

    Time frame: Up to six months.

Other outcomes

  1. Failure after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.

    Time frame: Up to six months.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2013
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.