PRognOstiC valuE of rEd Density in Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

243 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-03

Study Completion Date

2022-06-01

Brief Summary

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Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ulcerative colitis in clinical remission

Clinical remission with SCCAI \<3 at baseline and stable remission for the last 3 months

Red Density

Intervention Type DIAGNOSTIC_TEST

Image analysis of endoscopic images in patients with ulcerative colitis

Interventions

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Red Density

Image analysis of endoscopic images in patients with ulcerative colitis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of UC for at least 3 months
* Clinical remission with SCCAI \<3 at baseline and stable remission for the last 3 months
* Ability to give informed consent by the patient or legal representative in case of minority.

Exclusion Criteria

* Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid.
* Uncontrolled coagulopathy.
* Any planned change in UC related treatment (both escalation and de-escalation) after the baseline endoscopy
* Planned UC related surgery
* Previous subtotal or total colectomy
* Short bowel, ileostomy or colostomy
* Pregnancy at baseline
* Age younger than 16 years

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No