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OpenTrials
Completed

NCT Number: NCT03578692

Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Colon operation

    Time frame: 30 days

    100% direct approximation of inevitable surgery

Secondary outcomes

  1. No response to medical treatments

    Time frame: 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

  2. 30-day mortality

    Time frame: 30 days

    All-cause mortality within 30 days

Sponsors and collaborators

Lead sponsor

Gao Tao

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2018
Registry last updated
Jul 6, 2018

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

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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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