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Completed

NCT Number: NCT04564638

Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids

All episodes of patients with acute UC admitted to Tampere University Hospital and treated with intravenous corticosteroids between January 2007 and January 2016 were identified from patient records and reviewed. The risks for colectomy and for continuous use of corticosteroids were evaluated. Predictive factors were analysed.

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Key information

About this study

Data collected included epidemiological (gender, age at index flare, smoking status), clinical (UC duration, extent of the disease, prior Cs usage, disease severity, laboratory results at index flare) and treatment data (occurrence of new flares, need for further Cs therapy; CyA, thiopurines, biologics or colectomy during follow-up). The diagnosis of UC was made on basis of clinical history, symptoms, endoscopic and histological features. Disease extent was categorized by the Montreal classification and the severity of the flare was assessed by Mayo scoring system based on clinical and endoscopic characteristics. ASUC was characterized by more than six bloody stools/day along with any of the following: tachycardia, elevated temperature, anemia and/or ESR >30 mm/h (Truelove and Witt´s criteria)5. Alleviation of UC was defined as clinical response to intravenous corticosteroids with no need for colectomy or rescue therapy at the same hospitalization as the index flare. Relapse was defined as requiring further corticosteroid treatment, rehospitalization, rescue-therapy, or colectomy later in follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute severe ulcerative colitis treated first time with iv corticosteroids
  • Follow-up for at least six months after hospitalization or until colectomy.

Exlusion:

-Under 16 year of age

Treatment and study plan

Corticosteroid

Drug

Other names: cyclosporine

Primary outcomes

  1. Colectomy

    Time frame: Long-term follow-up. Years 2007-2016. Mean follow-up of 7.5 years.

    We reviewed patient records for data on need for surgery within follow-up. We identified patients who had emergency colectomy and patients who needed surgery within 1 year of index flare or within follow-up.

  2. Responce to Corticosteroid

    Time frame: Admission on index flare

    Responce to first intravenous corticosteroid was defined as no need for colectomy or rescue therapy within admission.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2020
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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