Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)

Completed

• Conditions: Ulcerative Colitis Acute; Surgery

• Registration Number: NCT03578692
• Lead Sponsor: Gao Tao

Brief Summary

Acute severe ulcerative colitis \[ASUC\] patients have high risk of no response to medical treatments and might miss the best timing for surgery when waiting for the medical response. Thus, we investigated whether biomarkers which could early predict the surgery risk of patients with ASUC on admission.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2018-01-31
• Study Completion: 2018-04-30
• Study First Submitted: 2018-05-07
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-04
• Last Update Submitted: 2018-07-04
• Study First Posted: 2018-07-06
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

The inclusion criterion was patients clearly diagnosed as acute severe ulcerative colitis.

Exclusion Criteria

Patients younger than 18 years-of-age, complicated with malignancy in colon and pregnant were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Colon operation	30 days	100% direct approximation of inevitable surgery

Secondary Outcome Measures

Name	Time	Method
No response to medical treatments	5 days	Medical treatments involve glucocorticoids, Immunosuppressant and biologicals for ulcerative colitis. The Oxford Index measured everyday, consisting of CRP and stool frequency, is used to evaluate the response to the treatment. If the Oxford Index does not reduce after 5-day medical treatment, this situation is deemed as no response to medical treatment
30-day mortality	30 days	All-cause mortality within 30 days