Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876690
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2021-05-03
Brief Title:
A Study of the Quality of Life in Adults With Crohns Disease With Complex Perianal Fistulas
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Quality of Life of Crohns Disease Patients With Complex Perianal Fistulas an Observational Cross-sectional Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONFLICT
Brief Summary:
The main aim of the study is to assess the quality of life of people with Crohns 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None