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

Sponsor

Tampere University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04564638

Collaborator

(none)

217

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Corticosteroid

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

217 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Sep 1, 2019

Outcome Measures

Primary Outcome Measures

Colectomy [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.
Responce to Corticosteroid [Admission on index flare]
Responce to first intravenous corticosteroid was defined as no need for colectomy or rescue therapy within admission.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tampere University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heli T Eronen, MD, specialist in internal medicine and gastroenterology, Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT04564638

Other Study ID Numbers:

R15518S

First Posted:

Sep 25, 2020

Last Update Posted:

Sep 25, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Heli T Eronen, MD, specialist in internal medicine and gastroenterology, Tampere University Hospital

corticosteroids, cyclosporine, colectomy, clinical outcome

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2020