Completed

Assessment of Ileal Pouch-anal Anastomosis or Ileo-rectal Anastomosis Outcomes in UC/PSC Patients

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Study Aim

This study aims to observe and compare the functional outcomes after reconstructive surgery with Ileal Pouch-anal Anastomosis or Ileo-rectal Anastomosis in patients with Ulcerative Colitis and Primary Sclerosing Cholangitis versus patients with Ulcerative Colitis only.

What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Bile Duct Diseases+13

+ Biliary Tract Diseases

+ Cholangitis

From 10 to 90 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: January 2010
See protocol details

Summary

Principal SponsorSahlgrenska University Hospital
Last updated: April 19, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2010

Actual date on which the first participant was enrolled.

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.

Principal SponsorSahlgrenska University Hospital
Last updated: April 19, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

175 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bile Duct DiseasesBiliary Tract DiseasesCholangitisColitisColonic DiseasesDigestive System DiseasesEnteritisGastroenteritisGastrointestinal DiseasesIleal DiseasesIleitisIntestinal DiseasesInflammatory Bowel DiseasesColitis, UlcerativeCholangitis, SclerosingPouchitis

Criteria

4 inclusion criteria required to participate
IPAA

IRA

PSC

UC

3 exclusion criteria prevent from participating
no consent

non-PSC

non-UC

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital

Gothenburg, SwedenOpen Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital in Google Maps
CompletedOne Study Center