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

NCT04876690 | Completed Results

• 1 other identifier: IBD-5007
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 5

Brief Summary

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 (CPF) 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.

Conditions

Crohn Disease; Rectal Fistula

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12]

  SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the physical component summary (PCS) and the mental component summary (MCS), of which the PCS component is presented in this outcome measure. The PCS score has a range of 0 to 100. Higher scores indicate better physical functioning.

  At inclusion visit (Day 1)

• Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12])

  SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the PCS and the MCS, of which the MCS component is presented in this outcome measure. The MCS score has a range of 0 to 100. Higher scores indicate better mental functioning.

  At inclusion visit (Day 1)

Secondary Outcomes (13)

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score

  At inclusion visit (Day 1)

• Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants

  At inclusion visit (Day 1)

• Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants

  At inclusion visit (Day 1)

• Fecal Incontinence as Assessed by Wexner Score

  At inclusion visit (Day 1)

• Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score

  At inclusion visit (Day 1)

Study Arms (1)

CD Participants With CPF

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with CD and CPFs in the Portuguese routine clinical practice will be assessed.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (5)

Centro Hospitalar e Universitario de Coimbra (CHUC)

Coimbra, 3000-075, Portugal

Location

Centro Hospitalar Universitario de Lisboa Central (CHULC)

Lisbon, 1169-050, Portugal

Location

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

Lisbon, 1649-028, Portugal

Location

Centro Hospitalar Universitario de Sao Joao (CHUSJ)

Porto, 4200-319, Portugal

Location

Centro Hospitalar Tondela-Viseu (CHTV)

Viseu, 3504-509, Portugal

Location

Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease; Rectal Fistula

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Intestinal Fistula; Digestive System Fistula; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: July 9, 2021
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: August 5, 2024
• Results First Posted: August 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

PT (5)