Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis
|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|
|Primary Completion Date :||February 2013|
|Study Completion Date :||November 2013|
U.S. FDA Resources
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. ]
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|