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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04564638
Enrollment
217
Registered
2020-09-25
Start date
2015-03-01
Completion date
2019-09-01
Last updated
2020-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

corticosteroids, cyclosporine, colectomy, clinical outcome

Brief summary

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.

Detailed description

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.

Interventions

DRUGCorticosteroid

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ColectomyLong-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.
Responce to CorticosteroidAdmission on index flareResponce to first intravenous corticosteroid was defined as no need for colectomy or rescue therapy within admission.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026