Impact of Therapeutic Intervention on Quality of Life in Patients With Ulcerative Colitis Depending on the Mucosal Healing Degree

Status: Recruiting
Location: See all (10) locations...
Study Type: Observational
SUMMARY

This study is therefore postulated as a clear alternative that evaluates patients´quality of life, and recognises fecal calprotectin as an inflammatory marker. Longitudinal, prospective, multi-center cohort study to measure the impact that the therapeutic attitude (treatment intensification/de-intensification o escalation/de-escalation) has on the quality of life of patients with UC given a colonoscopy revealing mucosal healing (Mayo 0, Mayo 1); considering as treatment intensification/de-intensification a dose increase or decrease on the same line of treatment, and escalation/de-escalation if there is a change to a new line of treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• UC diagnosed.

• Age ≥ 18.

• Signed and dated informed consent form.

• Have undergone a Mayo 0 or 1 endoscopic score colonoscopy while in clinical remission.

Locations
Other Locations
Spain
Hospital Universitario de Cáceres
RECRUITING
Cáceres
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario La Princesa
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital de Santa Bárbara de Puertollano
RECRUITING
Puertollano
Hospital Universitari Parc Taulí
RECRUITING
Sabadell
Hospital Universitario de Canarias
RECRUITING
San Cristóbal De La Laguna
Hospital Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario de Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario. Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Inmaculada Alonso Abreu
macuaa@hotmail.com
646555151
Backup
Secretaría Científica
secretariacientifica2@geteccu.org
635899553
Time Frame
Start Date: 2022-11-18
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 114
Treatments
Mayo 0
Patients with an established diagnosis of UC through regular criteria (clinical, analytical, endoscopic, radiological and/or histological ones), in clinical remission (partial Mayo score ≤2) for at least three months, who had undergone surveillance colonoscopy after 12 months from the study outset, with a Mayo 0 endoscopic activity.
Mayo 1
Patients with an established diagnosis of UC through regular criteria (clinical, analytical, endoscopic, radiological and/or histological ones), in clinical remission (partial Mayo score ≤2) for at least three months, who had undergone surveillance colonoscopy after 12 months from the study outset, with a Mayo 1 endoscopic activity.
Sponsors
Leads: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

This content was sourced from clinicaltrials.gov

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