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

Study Purpose

The main aim of the study is to assess the quality of life of people with Crohn's disease after treatment for complex perianal fistulas in a standard clinic setting. Study doctors will review the participants' medical records in the last 3 years. Participants will also be asked to visit the clinic once to complete 1 questionnaire on their quality of life.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Diagnosed with CD. 2. Presence of CPF(s), defined as >=1 of the following criteria:
  • - High intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric location; - >=2 external openings; - Associated collections.
3. Attending routine gastroenterology appointments at the participating hospitals.

Exclusion Criteria:

1. Diagnosed with ulcerative colitis or indeterminate inflammatory bowel disease (IBD). 2. With non-complex fistulas or with fistulas types other than perianal (example, rectovaginal).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04876690
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Portugal
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease, Rectal Fistula
Study Website: View Trial Website
Additional Details

This is a national, observational, cross-sectional study. The study will assess the general QoL among CD participants with CPFs in the Portuguese routine clinical practice. This study will enroll approximately 80 participants. All participants will be enrolled in one observational cohort. The data will be collected retrospectively, from the medical records, on healthcare resource utilization and on the pharmacological and surgical treatments used for the management of CPFs in the three years prior to the inclusion visit. This multi-center trial will be conducted in Portugal. The overall duration of this study is approximately 8 months.

Arms & Interventions

Arms

: All Participants

Participants diagnosed with CD and CPF in the Portuguese routine clinical practice will be assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years will be obtained from the medical records.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Coimbra, Portugal

Status

Not yet recruiting

Address

Centro Hospitalar e Universitario de Coimbra (CHUC)

Coimbra, , 3000-075

Site Contact

Site Contact

fportela@chuc.min-saude.pt

+351 966329152

Lisboa, Portugal

Status

Not yet recruiting

Address

Centro Hospitalar Universitario de Lisboa Central (CHULC)

Lisboa, , 1169-050

Site Contact

Site Contact

jaime.ramos.estudos@gmail.com

+351 966329715

Lisboa, Portugal

Status

Recruiting

Address

Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria (CHULN-HSM)

Lisboa, , 1649-028

Site Contact

Site Contact

Samuelrmfernandes@gmail.com

+351 968644836

Porto, Portugal

Status

Not yet recruiting

Address

Centro Hospitalar Universitario de Sao Joao (CHUSJ)

Porto, , 4200-319

Site Contact

Site Contact

fm@med.up.pt

+351 962302089

Centro Hospitalar Tondela-Viseu (CHTV), Viseu, Portugal

Status

Not yet recruiting

Address

Centro Hospitalar Tondela-Viseu (CHTV)

Viseu, , 3504-509

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