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Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01798953
Enrollment
175
Registered
2013-02-26
Start date
2010-01-31
Completion date
2013-11-30
Last updated
2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications, Pouchitis, Primary Sclerosing Cholangitis, Ulcerative Colitis

Keywords

Ulcerative Colitis, Primary Sclerosing Cholangitis, Ileal pouch-anal anastomosis, Ileorectal anastomosis, Surgical outcome, Functional outcome, Failure

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.

Interventions

None listed

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* UC * PSC * IPAA * IRA

Exclusion criteria

* non-UC * non-PSC * no consent

Design outcomes

Primary

MeasureTime frame
Functional outcome after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.Up to six months

Secondary

MeasureTime frame
Complications after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.Up to six months.

Other

MeasureTime frame
Failure after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.Up to six months.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026