Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)

NCT ID: NCT03578692

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 146 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2018-04-30

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.

Conditions

Ulcerative Colitis Acute; Surgery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gao Tao

OTHER

Sponsor Role: lead

Responsible Party

Gao Tao

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2018NLY052

Identifier Type: -

Identifier Source: org_study_id