Ulcerative ColitisREXs_UCNCT03947931
Russian Extremely Severe Ulcerative Colitis Study
An observational study of Ulcerative Colitis and Inflammatory Bowel Diseases, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases
- How many people
- 71 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jun 2019to 20 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who admissions with acute severe ulcerative colitis and classified as extremely severe UC.
Who may be able to join
- 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).
Who cannot join
- Pregnancy;
- Infectious, ischemic colitis;
- Transformation of diagnosis into Crohn's disease;
- Medical treatment failure before the admission.
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Scientific Centre of Coloproctology, Russian Federation
Moscow
About this study
Official title: 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.
Read the 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.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Keywords
- ulcerative colitis, acute severe ulcerative colitis, predictors of colectomy
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General group | Patient with extremely severe ulcerative colitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient colectomy rate
Operation performed due to the treatment failure and complications during hospitalization.
Measured: 30 days
Secondary outcomes (3)
Long-term colectomy rate
Measured: 12 months
Total mortality
Measured: 12 months
Postoperative complications
Compared between early and later surgical treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start20 Jun 2019
- Primary completion20 Jun 2021
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Achkasov Sergey, State Scientific Centre of Coloproctology, Russian Federation
- Investigators
- Ayrat Mingazov, Study chair, Sub-investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947931
- Sponsor's protocol ID
- 127
- Acronym
- REXs_UC
- Status last verified
- Aug 2022
- First submitted
- 9 May 2019
- Last updated
- 25 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Non-randomized Study: Predictors of Colectomy in Patients With Extremely Severe Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT03947931
- Acronym / sponsor ID
- REXs_UC / 127
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Keywords
- ulcerative colitis, acute severe ulcerative colitis, predictors of colectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General group | – | –Patient with extremely severe ulcerative colitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who admissions with acute severe ulcerative colitis and classified as extremely severe UC.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- Pregnancy;
- Infectious, ischemic colitis;
- Transformation of diagnosis into Crohn's disease;
- Medical treatment failure before the admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inpatient colectomy rate
Time frame: 30 days
Operation performed due to the treatment failure and complications during hospitalization.
3 secondary outcomes
Long-term colectomy rate
Time frame: 12 months
Total mortality
Time frame: 12 months
Postoperative complications
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
RecruitingPhase 2
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Ulcerative Colitis, Inflammatory Bowel Diseases
Enrolling by invitationPhase 2
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
Ulcerative Colitis, Inflammatory Bowel Diseases
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Ulcerative Colitis
RecruitingPhase 2
Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
Crohn's Disease, Ulcerative Colitis
RecruitingObservational study
Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayrat Mingazov study chair
Sub-investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Inflammatory Bowel Diseases, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inpatient colectomy rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.