Russian Extremely Severe Ulcerative Colitis Study

Completed

• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis

• Registration Number: NCT03947931
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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.

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Study Start: 2019-06-20
• Primary Completion: 2021-06-20
• Study Completion: 2022-06-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inpatient colectomy rate	30 days	Operation performed due to the treatment failure and complications during hospitalization.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	12 months	Compared between early and later surgical treatment
Long-term colectomy rate	12 months
Total mortality	12 months

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology, Russian Federation; 🇷🇺 Moscow, Russian Federation