Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578692
• Other study ID #: 2018NLY052
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: April 30, 2018

Study information

• Verified date: July 2018
• Source: Nanjing PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: April 30, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Surgery
• Ulcer
• Ulcerative Colitis Acute

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gao Tao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colon operation	100% direct approximation of inevitable surgery	30 days
Secondary	No response to medical treatments	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
Secondary	30-day mortality	All-cause mortality within 30 days	30 days