NCT03947931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 20, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

May 9, 2019

Last Update Submit

August 24, 2022

Conditions

Ulcerative ColitisInflammatory Bowel Diseases

Keywords

ulcerative colitis, acute severe ulcerative colitis, predictors of colectomy

Outcome Measures

Primary Outcomes (1)

  • Inpatient colectomy rate

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

    30 days

Secondary Outcomes (3)

  • Long-term colectomy rate

    12 months

  • Total mortality

    12 months

  • Postoperative complications

    12 months

Study Arms (1)

General group

Patient with extremely severe ulcerative colitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • Pregnancy;
  • Infectious, ischemic colitis;
  • Transformation of diagnosis into Crohn's disease;
  • Medical treatment failure before the admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Scientific Centre of Coloproctology, Russian Federation

Moscow, Russia

Location

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Ayrat Mingazov

    Sub-investigator

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Achkasov Sergey, Professor of State Scientific Centre of Coloproctology, Head of sugery and oncology of colon department, Moscow

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 13, 2019

Study Start

June 20, 2019

Primary Completion

June 20, 2021

Study Completion

June 20, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)