An observational study in Ulcerative Colitis, Primary Sclerosing Cholangitis and Pouchitis, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Open to participants aged 10 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-04-19.
Sponsored by Sahlgrenska University Hospital · Observational
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.
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's enrollment of 175 is below the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.
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Patients with UC/PSC vs patients with UC only reconstructed surgically with IPAA or IRA.
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Exclusion Criteria:
Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileal pouch-anal anastomosis
Patients with ulcerative colitis reconstructed with ileal pouch-anal anastomosis.
Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileorectal anastomosis.
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.
Plan to share: Yes — PubMed
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The record gives a start of Jan 2010, a primary completion of Feb 2013 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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