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Trial record 4 of 42 for:    "Primary sclerosing cholangitis"

Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mattias Block, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01798953
First received: February 19, 2013
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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
Ulcerative Colitis
Primary Sclerosing Cholangitis
Pouchitis
Complications

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Functional outcome after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only. [ Time Frame: Up to six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only. [ Time Frame: Up to six months. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Failure after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only. [ Time Frame: Up to six months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 175
Study Start Date: January 2010
Estimated Study Completion Date: November 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798953

Locations
Sweden
Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital
Göteborg, Sweden, 41685
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Lars G Börjesson, Ass Prof Department of Surgery, Sahlgrenska, Göteborg
  More Information

No publications provided

Responsible Party: Mattias Block, Doctor, Surgeon, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01798953     History of Changes
Other Study ID Numbers: 326-10
Study First Received: February 19, 2013
Last Updated: February 22, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
Ulcerative Colitis
Primary Sclerosing Cholangitis
Ileal pouch-anal anastomosis
Ileorectal anastomosis
Surgical outcome
Functional outcome
Failure

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Colitis
Colitis, Ulcerative
Ulcer
Bile Duct Diseases
Biliary Tract Diseases
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014