Skip to main content
OpenTrials
Completed

NCT Number: NCT03947931

Russian Extremely Severe Ulcerative Colitis Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

State Scientific Centre of Coloproctology, Russian Federation

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Inpatient colectomy rate

    Time frame: 30 days

    Operation performed due to the treatment failure and complications during hospitalization.

Secondary outcomes

  1. Long-term colectomy rate

    Time frame: 12 months

  2. Total mortality

    Time frame: 12 months

  3. Postoperative complications

    Time frame: 12 months

    Compared between early and later surgical treatment

Sponsors and collaborators

Lead sponsor

State Scientific Centre of Coloproctology, Russian Federation

Other Gov

Registry information

Official study title

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

Acronym: REXs_UC

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 13, 2019
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.