Clinical Trial: Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Sahlgrenska University Hospital, Sweden

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

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Sahlgrenska University Hospital, Sweden

Dates:
Date Received: February 19, 2013
Date Started: January 2010
Date Completion:
Last Updated: April 18, 2016
Last Verified: April 2016