An observational study in Ulcerative Colitis Acute and Surgery, sponsored by Gao Tao. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-06.
Sponsored by Gao Tao · Observational
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 146 is above the median of 105 across 247 observational studies indexed under Colitis.
Browse Colitis studies →Gao Tao is the lead sponsor of 2 studies on the registry; none are open to participants now.
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All acute severe ulcerative colitis patients were admitted in hospital and prospectively followed during the study period.
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.
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.
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.
Colon operation
100% direct approximation of inevitable surgery
Time frame: 30 days
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
Time frame: 5 days
30-day mortality
All-cause mortality within 30 days
Time frame: 30 days
No study locations are listed for this record.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Gao Tao