Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date February 19, 2013
First Posted Date February 26, 2013
Last Update Posted Date April 19, 2016
Study Start Date January 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2013)
Functional outcome after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only. [ Time Frame: Up to six months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01798953 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 22, 2013)
Complications after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only. [ Time Frame: Up to six months. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 22, 2013)
Failure after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only. [ Time Frame: Up to six months. ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis
Official Title Ileal Pouch-anal Anastomosis or Ileo-rectal Anastomosis for Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis?
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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with UC/PSC vs patients with UC only reconstructed surgically with IPAA or IRA.
Condition
  • Ulcerative Colitis
  • Primary Sclerosing Cholangitis
  • Pouchitis
  • Complications
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 22, 2013)
175
Original Estimated Enrollment Same as current
Actual Study Completion Date November 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • UC
  • PSC
  • IPAA
  • IRA

Exclusion Criteria:

  • non-UC
  • non-PSC
  • no consent
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01798953
Other Study ID Numbers 326-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: PubMed
Responsible Party Mattias Block, Sahlgrenska University Hospital, Sweden
Study Sponsor Sahlgrenska University Hospital, Sweden
Collaborators Not Provided
Investigators
Principal Investigator: Lars G Börjesson, Ass Prof Department of Surgery, Sahlgrenska, Göteborg
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date April 2016