Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)

July 4, 2018 updated by: Gao Tao

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All acute severe ulcerative colitis patients were admitted in hospital and prospectively followed during the study period.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Surgery group
The protocol for patients assigned to surgery group was as follows. ASUC patients were admitted in, estimated their baseline situations and tested their blood and fecal indicators including PCT, IL-6 and FC on admission. All patients were treated according to the ECCO guideline 2012. Patients who showed bad response to medicine (glucocorticoid for 5 days and rescue therapy for 3 days) were recommended and classified in the surgery group. Their baseline manifestations were collected and compared with the medical group, to exploit the baseline indicators with great sensitive and specificity predicting the high risk for surgery.
Medical group
The protocol for patients assigned to medical group was as follows. ASUC patients were admitted in, estimated their baseline situations and tested their blood and fecal indicators including PCT, IL-6 and FC on admission. All patients were treated according to the ECCO guideline 2012. Patients who showed response to medicine (glucocorticoid for 5 days or rescue therapy for 3 days) were classified in the medical group. Their baseline manifestations were collected and compared with the surgery group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colon operation
Time Frame: 30 days
100% direct approximation of inevitable surgery
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 days
30-day mortality
Time Frame: 30 days
All-cause mortality within 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gao Tao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

July 4, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018NLY052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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