N/A N=15

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

Crohn Disease · Rectal Fistula

Bottom Line

View on ClinicalTrials.gov: NCT04876690 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12] — 45.36 score on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Takeda
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12]	45.36	—
PRIMARY Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12])	38.00	—
SECONDARY Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score	45.00	—
SECONDARY Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants	44.57	—
SECONDARY Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants	72.80	—
SECONDARY Fecal Incontinence as Assessed by Wexner Score	7.43	—
SECONDARY Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score	3.80; 57.78; 58.89; 52.67	—
SECONDARY Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years	15; 3; 5	—
SECONDARY Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics	15; 8; 7; 0; 9; 4	—
SECONDARY Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics	4; 1; 3; 5; 2; 8	—
SECONDARY Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF	2; 13; 7; 10; 2; 2	—
SECONDARY Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables	48.63; 42.50; 44.01; 48.22; 48.18; 43.25	=0.1217
SECONDARY Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables	36.27; 39.51; 35.84; 41.22; 45.19; 33.45	=0.4814
SECONDARY Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables	-0.072; 0.210; -0.014; -0.270; -0.185; 0.071	=0.8001
SECONDARY Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables	0.484; 0.022; -0.132; 0.077; -0.323; -0.018	=0.0674

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04876690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.