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Russian Extremely Severe Ulcerative Colitis Study

Multicenter Prospective Non-randomized Study: Predictors of Colectomy in Patients With Extremely Severe Ulcerative Colitis.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03947931
Acronym
REXs_UC
Enrollment
71
Registered
2019-05-13
Start date
2019-06-20
Completion date
2022-06-20
Last updated
2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Ulcerative Colitis

Keywords

ulcerative colitis, acute severe ulcerative colitis, predictors of colectomy

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.

Interventions

None listed

Sponsors

State Scientific Centre of Coloproctology, Russian Federation
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Inpatient colectomy rate30 daysOperation performed due to the treatment failure and complications during hospitalization.

Secondary

MeasureTime frameDescription
Long-term colectomy rate12 months
Total mortality12 months
Postoperative complications12 monthsCompared between early and later surgical treatment

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026