NCT03578692

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

6.1 years

First QC Date

May 7, 2018

Last Update Submit

July 4, 2018

Conditions

Ulcerative Colitis AcuteSurgery

Keywords

acute severe ulcerative colitispredictive indicatorsurgery

Outcome Measures

Primary Outcomes (1)

  • Colon operation

    100% direct approximation of inevitable surgery

    30 days

Secondary Outcomes (2)

  • No response to medical treatments

    5 days

  • 30-day mortality

    30 days

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 7, 2018

First Posted

July 6, 2018

Study Start

January 1, 2012

Primary Completion

January 31, 2018

Study Completion

April 30, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07