Clinical trial NCT01798953: 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?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Primary Sclerosing Cholangitis
Pouchitis
Complications
Keywords: Ulcerative Colitis
Primary Sclerosing Cholangitis
Ileal pouch-anal anastomosis
Ileorectal anastomosis
Surgical outcome
Functional outcome
Failure
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 175
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with UC/PSC vs patients with UC only reconstructed surgically with IPAA or IRA.

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.

Eligibility criteria: Inclusion Criteria:

* UC
* PSC
* IPAA
* IRA

Exclusion Criteria:

* non-UC
* non-PSC
* no consent

Primary outcomes:
measure: Functional outcome after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.
timeFrame: Up to six months
Secondary outcomes:
measure: Complications after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.
timeFrame: Up to six months.
Other outcomes:
measure: Failure after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.
timeFrame: Up to six months.
Locations:
city: Göteborg
country: Sweden
facility: Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital
Study officials:
affiliation: Department of Surgery, Sahlgrenska, Göteborg
name: Lars G Börjesson, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: