Russian Extremely Severe Ulcerative Colitis Study

Ulcerative Colitis Clinical Trial

— REXs_UC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03947931
• Other study ID #: 127
• Status: Completed
• Start date: June 20, 2019
• Est. completion date: June 20, 2022

Study information

• Verified date: August 2022
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology, Russian Federation	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inpatient colectomy rate	Operation performed due to the treatment failure and complications during hospitalization.	30 days
Secondary	Long-term colectomy rate		12 months
Secondary	Total mortality		12 months
Secondary	Postoperative complications	Compared between early and later surgical treatment	12 months