Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798953
• Other study ID #: 326-10
• Status: Completed
• Phase: N/A
• First received: February 19, 2013
• Last updated: April 18, 2016
• Start date: January 2010
• Est. completion date: November 2013

Study information

• Verified date: April 2016
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: November 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 90 Years

Eligibility

Inclusion Criteria:

• UC

• PSC

• IPAA

• IRA

Exclusion Criteria:

• non-UC

• non-PSC

• no consent

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Colitis
• Colitis, Ulcerative
• Complications
• Pouchitis
• Primary Sclerosing Cholangitis
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Sweden	Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Failure after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.		Up to six months.	No
Primary	Functional outcome after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.		Up to six months	No
Secondary	Complications after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.		Up to six months.	No