Assessment of Ileal Pouch-anal Anastomosis or Ileo-rectal Anastomosis Outcomes in UC/PSC Patients
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.
Data Collection
Collected from past medical records and data - RetrospectiveBile Duct Diseases+13
+ Biliary Tract Diseases
+ Cholangitis
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.175 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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