PRognOstiC valuE of rEd Density in Ulcerative Colitis (PROCEED-UC)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Diagnostic Test: Red Density

Study type: Observational

Funder types: Other

Identifiers

NCT04408703

s63012

Details and patient eligibility

About

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.

Enrollment: 243 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

243 participants in 1 patient group

Ulcerative colitis in clinical remission

Description:

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

Treatment:

Diagnostic Test: Red Density