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Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

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ClinicalTrials.gov Identifier: NCT01798953
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Mattias Block, Sahlgrenska University Hospital, Sweden

Study Description
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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.

Condition or disease
Ulcerative Colitis Primary Sclerosing Cholangitis Pouchitis Complications

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.


Study Design
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Study Type : Observational
Actual Enrollment : 175 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Ileal Pouch-anal Anastomosis or Ileo-rectal Anastomosis for Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis?
Study Start Date : January 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
UC/PSC with IPAA
Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileal pouch-anal anastomosis
UC with IPAA
Patients with ulcerative colitis reconstructed with ileal pouch-anal anastomosis.
UC/PSC with IRA
Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileorectal anastomosis.
UC with IRA
Patients with ulcerative colitis reconstructed with ileorectal anastomosis.


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

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with UC/PSC vs patients with UC only reconstructed surgically with IPAA or IRA.
Criteria

Inclusion Criteria:

  • UC
  • PSC
  • IPAA
  • IRA

Exclusion Criteria:

  • non-UC
  • non-PSC
  • no consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798953


Locations
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Sweden
Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital
Göteborg, Sweden, 41685
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Lars G Börjesson, Ass Prof Department of Surgery, Sahlgrenska, Göteborg
More Information
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Responsible Party: Mattias Block, Doctor, Surgeon, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01798953     History of Changes
Other Study ID Numbers: 326-10
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: PubMed
Keywords provided by Mattias Block, Sahlgrenska University Hospital, Sweden:
Ulcerative Colitis
Primary Sclerosing Cholangitis
Ileal pouch-anal anastomosis
Ileorectal anastomosis
 Surgical outcome
Functional outcome
Failure
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Cholangitis
Cholangitis, Sclerosing
Pouchitis
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Bile Duct Diseases
Biliary Tract Diseases
Ileitis
Enteritis
Ileal Diseases