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
|Condition or disease|
|Ulcerative Colitis Primary Sclerosing Cholangitis Pouchitis Complications|
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|
|Actual Enrollment :||175 participants|
|Observational Model:||Case Control|
|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|
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.
- Functional outcome after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only. [ Time Frame: Up to six months ]
- Complications after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only. [ Time Frame: Up to six months. ]
- Failure after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only. [ Time Frame: Up to six months. ]
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
|Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital|
|Göteborg, Sweden, 41685|
|Principal Investigator:||Lars G Börjesson, Ass Prof||Department of Surgery, Sahlgrenska, Göteborg|