Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)

Clinical Value of Inflammation-related Indicators of Blood and Fecal Calprotectin in Predicting the Surgery Rate of Acute Severe Ulcerative Colitis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03578692

Enrollment

146

Registered

2018-07-06

Start date

2012-01-01

Completion date

2018-04-30

Last updated

2018-07-06

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

Conditions

Surgery, Ulcerative Colitis Acute

Keywords

acute severe ulcerative colitis, predictive indicator, surgery

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Colon operation	30 days	100% direct approximation of inevitable surgery

Secondary

Measure	Time frame	Description
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

Outcome results