Acute Severe Ulcerative Colitis Prospective Cohort Study
Research type
Research Study
Full title
Evaluating Clinical, Endoscopic and Biomarker Variables in Assessment, Treatment and Outcome Endpoints in Acute Severe Ulcerative Colitis - ELEVATE ASUC
IRAS ID
259837
Contact name
Shaji Sebastian
Contact email
Sponsor organisation
Hull University Teaching Hospital NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Ulcerative colitis (UC) causes inflammation and ulceration on the inner lining of the colon (the large bowel). Sometimes, the condition can become so severe that a hospital admission is required (Acute Severe Ulcerative Colitis – ASUC). ASUC can be a life threatening condition for which specific treatment plans within the hospital setting are required. Unfortunately these treatment plans are largely ill-defined with approximately 30 - 40% of patients admitted with ASUC requiring emergency surgery to remove the large bowel (Colectomy). Colonoscopy (a small camera placed into the bowel) and various blood tests are used to assess the severity of the problem but these are not fully accurate in predicting risks and hence treatment can be very variable between clinicians and hospitals. This variability in practice can potentially impact on patient outcomes. \n\nIntravenous corticosteroids is the mainstay of management but approximately 40% patients will not respond to the steroids. If steroids are not improving the condition then alternative treatments can be given such as Infliximab or cyclosporine and failing these emergency colectomy, which has additional risks. \n\nCurrently there are no ways to accurately predict which patients are likely to respond to steroids and /or rescue therapy within this setting. Hence healthcare professionals have no tools to ‘personalise’ care for ASUC by predicting up front which patients will fail initial medical therapy and thus predict those who may benefit form rescue therapy or early surgery.\n\nThis study will collect detailed ‘real time’ data from a large cohort of patients with ASUC across the UK to facilitate the development of a tool using the data from clinical, endoscopy and blood markers to predict treatment outcomes in ASUC and improve quality of care.\n
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0278
Date of REC Opinion
29 Aug 2019
REC opinion
Favourable Opinion