Russian Extremely Severe Ulcerative Colitis Study (REXs_UC)

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis

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 Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • State Scientific Centre of Coloproctology, Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who admissions with acute severe ulcerative colitis and classified as extremely severe UC.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
General group; Patient with extremely severe ulcerative colitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inpatient colectomy rate	Operation performed due to the treatment failure and complications during hospitalization.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total mortality		12 months
Long-term colectomy rate		12 months
Postoperative complications	Compared between early and later surgical treatment	12 months

Collaborators and Investigators

• Sponsor: State Scientific Centre of Coloproctology, Russian Federation
• Investigators: Study Chair: Ayrat Mingazov, Sub-investigator

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Actual): June 20, 2021
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: ulcerative colitis, acute severe ulcerative colitis, predictors of colectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Ulcer; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 127 (Tumor Vaccine Group)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No