Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

NCT ID: NCT01798953

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-11-30

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 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.

Conditions

Ulcerative Colitis; Primary Sclerosing Cholangitis; Pouchitis; Complications

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

UC/PSC with IPAA

Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileal pouch-anal anastomosis

No interventions assigned to this group

UC with IPAA

Patients with ulcerative colitis reconstructed with ileal pouch-anal anastomosis.

No interventions assigned to this group

UC/PSC with IRA

Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileorectal anastomosis.

No interventions assigned to this group

UC with IRA

Patients with ulcerative colitis reconstructed with ileorectal anastomosis.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• UC
• PSC
• IPAA
• IRA

Exclusion Criteria

• non-UC
• non-PSC
• no consent

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mattias Block

Doctor, Surgeon, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars G Börjesson, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Sahlgrenska, Göteborg

Locations

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

Gothenburg, Göteborg, Sweden

Countries

Sweden

Other Identifiers

326-10

Identifier Type: -

Identifier Source: org_study_id