Health-Related Quality of Life in Crohn's Disease Participants With Complex Perianal Fistula Before and After Treatment

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-26

Study Completion Date

2021-05-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the impact of treatment (medical and/or surgical) on Health-related Quality of Life (HRQoL) in participants with Crohn's Disease (CD) and Complex Perianal Fistula (CPF), by the Quality of Life in patients with Anal Fistula Questionnaire (QoLAF-Q), at 12 months after treatment initiation in routine clinical practice.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas

NCT04876690

Crohn Disease Rectal Fistula

COMPLETED

Comparison of Quality of Life With or Without Automatic Seton Placement in Perianal Crohn's Fistula

NCT05330416

Crohn Disease

UNKNOWN NA

Impact of Therapeutic Intervention on Quality of Life in Patients With Ulcerative Colitis

NCT05271773

IBD-Inflammatory Bowel Disease UC - Ulcerative Colitis

COMPLETED

Study of the 12-month Efficacy of Stem Cell Injection in Crohn's Disease With Complex Ano-perineal Fistula

NCT05177003

Crohn Disease Ano Fistula

UNKNOWN

Anal Crohn Fistula Surgery

NCT01388257

Crohn Disease Fistula Anoperineal Fistula +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective follow-up post-authorization observational study of participants with CD and CPF. The study will provide real-world data on how CPF treatments in CD participants affect their HRQoL.

The study will enroll approximately 300 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Spain. The study will collect data from a routine medical practice visits for CD participants with CPF and an application that will be designed ad hoc and will passively record participant's data. The overall duration of this study will be approximately 31 months. Participants will be followed up at Months 6 and 12 post-treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease Inflammatory Bowel Disease Gastrointestinal Diseases Intestinal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All Participants

Participants diagnosed with CD and CPF from approximately 20 Spanish hospitals, who will initiate medical or surgical treatment for their CPF within the eligibility period from Sep 2020 to Sep 2021, will be observed prospectively for approximately 31 months.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Diagnosed with CD and CPF (defined as a fistula meeting any of the following criteria: high location \[high intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric\], multiple external openings, perianal abscess, anal stenosis, or proctitis).
2. Has tried and failed at least one prior treatment for CPF.
3. Starting a new pharmacological or surgical treatment for CPF.

Exclusion Criteria

1. Diagnosed with indeterminate/unspecified type of inflammatory bowel disease (IBD).
2. Diagnosed with ulcerative colitis.
3. Diagnosed with fistula other than CPF (example rectovaginal).
4. Treated with darvadstrocel or other stem cells-based therapies within the eligibility period.
5. Previous fecal incontinence.
6. Lost to site follow-up for reasons other than death.
7. Participates or plans to participate in any interventional clinical trial.
8. Non fluent in Spanish.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No