Clinical trial NCT03947931: Russian Extremely Severe Ulcerative Colitis Study
Official title: Multicenter Prospective Non-randomized Study: Predictors of Colectomy in Patients With Extremely Severe Ulcerative Colitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Inflammatory Bowel Diseases
Keywords: ulcerative colitis, acute severe ulcerative colitis, predictors of colectomy
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2019-05-13
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who admissions with acute severe ulcerative colitis and classified as extremely severe UC.

Brief summary: The purpose of this study is prove the need to selection of a extremely severe ulcerative colitis, to identify predictors of colectomy, which will reduce the optimal time for surgery.

Detailed description: Acute severe ulcerative colitis is a life threatening disease,total mortality rate can reach 17%, and the frequency of surgical treatment approximately 40%. Standard conservative therapy in these patients is often ineffective and the optimal timing of the surgical treatment has not yet been established.

In the Russian clinical guidelines for the treatment of ulcerative colitis, the extremely severe ulcerative colitis is added to the classification of the severity.

The extremely severe ulcerative colitis is a severe, according to the criteria of Truelove, Witts and the endoscopic picture of deep, extensive ulcerative defects of the mucosa, up to the muscular layer with the formation of mucosal islets including albumin reduction.

Conservative treatment of patients with extremely severe ulcerative colitis worsens treatment outcomes only. The authors of the study want to prove that patients with a extremely severe ulcerative colitis need a colectomy in a short time.

Is there a need for long-term follow-up, conservative treatment of high-risk patients? Is it safe to perform early surgical treatment without long-term conservative treatment? This study will allow to answer these questions and help doctors in the treatment of such patients anywhere in Russia and not only.

Eligibility criteria: Inclusion Criteria:

* Acute Severe Colitis according to the Truelove and Witt's Criteria;
* Extremely severe activity according endoscopic picture of deep, extensive ulcerative defects of the mucosa, up to the muscular layer with the formation of mucosal islets including albumin reduction (lower 31 g/l).

Exclusion Criteria:

* Pregnancy;
* Infectious, ischemic colitis;
* Transformation of diagnosis into Crohn's disease;
* Medical treatment failure before the admission.

Primary outcomes:
measure: Inpatient colectomy rate
timeFrame: 30 days
Secondary outcomes:
measure: Long-term colectomy rate
timeFrame: 12 months
measure: Total mortality
timeFrame: 12 months
measure: Postoperative complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology, Russian Federation
Study officials:
affiliation: Sub-investigator
name: Ayrat Mingazov
role: STUDY_CHAIR
References: