Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551194
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Prevalence Characteristics Management and Outcomes of Difficult-to-treat Inflammatory Bowel Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevalence Characteristics Management and Outcomes of Difficult-to-treat Inflammatory Bowel Disease Multicenter Retrospective Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DTT-IBD
Brief Summary:
Crohns disease CD and ulcerative colitis UC are the two main types of chronic inflammatory bowel disease IBD Despite recent advances many patients do not respond to available treatments and or lose response over time
In 2023 the International Organisation for the Study of IBD IOIBD proposed a common definition of difficult-to-treat inflammatory bowel disease IBD-IBD to homogenise terminology and promote research into patients most in need of new treatments and therapeutic strategies According to the IOIBD criteria IBD is defined by any of the following failure of two or more advanced treatments with different mechanisms of action postoperative recurrence of Crohns disease after two or more bowel resections pouchitis refractory to antibiotics complex perianal Crohns disease or the presence of psychiatric comorbidity that prevents adequate therapeutic management
As the definition of DTT-IBD is very recent the prevalence and risk factors of DTT-IBD are not yet known This study aims to determine the prevalence of DTT-IBD in the patient population and the risk factors associated with the development of DTT-IBD The study will be conducted as a retrospective cross-sectional study in two large tertiary care centers IRCCS Ospedale San Raffaele and IRCCS Humanitas Research Hospital both in Milan Italy The study will evaluate the criteria and risk factors for DTT-IBD in the latest available gastroenterological examination report provided it was performed in the last 5 years from 1 January 2019
In 2023 the International Organisation for the Study of IBD IOIBD proposed a common definition of difficult-to-treat inflammatory bowel disease IBD-IBD to homogenise terminology and promote research into patients most in need of new treatments and therapeutic strategies According to the IOIBD criteria IBD is defined by any of the following failure of two or more advanced treatments with different mechanisms of action postoperative recurrence of Crohns disease after two or more bowel resections pouchitis refractory to antibiotics complex perianal Crohns disease or the presence of psychiatric comorbidity that prevents adequate therapeutic management
As the definition of DTT-IBD is very recent the prevalence and risk factors of DTT-IBD are not yet known This study aims to determine the prevalence of DTT-IBD in the patient population and the risk factors associated with the development of DTT-IBD The study will be conducted as a retrospective cross-sectional study in two large tertiary care centers IRCCS Ospedale San Raffaele and IRCCS Humanitas Research Hospital both in Milan Italy The study will evaluate the criteria and risk factors for DTT-IBD in the latest available gastroenterological examination report provided it was performed in the last 5 years from 1 January 2019
Detailed Description:
This is a multicentre retrospective cross-sectional study with two aims
1 To evaluate the prevalence of difficult-to-treat IBD
2 To evaluate which and how demographic and clinical variables affect the risk of DTT-IBD
The subjects considered are adult patients 18 years diagnosed with UC or CD followed at San Raffaele Hospital and Humanitas Research Hospital
Crohns disease CD and ulcerative colitis UC are the two main types of chronic inflammatory bowel disease IBD Despite recent advances many patients do not respond to available treatments and or lose response over time
In 2023 the International Organisation for the Study of IBD IOIBD proposed a common definition of difficult-to-treat inflammatory bowel disease IBD-IBD to homogenise terminology and promote research into patients most in need of new treatments and therapeutic strategies According to the IOIBD criteria IBD is defined by any of the following failure of two or more advanced treatments with different mechanisms of action postoperative recurrence of Crohns disease after two or more bowel resections pouchitis refractory to antibiotics complex perianal Crohns disease or the presence of psychiatric comorbidity that prevents adequate therapeutic management
As the definition of DTT-IBD is very recent the prevalence and risk factors of DTT-IBD are not yet known This study aims to determine the prevalence of DTT-IBD in the patient population and the risk factors associated with the development of DTT-IBD The study will be conducted as a retrospective cross-sectional study in two large tertiary care centers IRCCS Ospedale San Raffaele and IRCCS Humanitas Research Hospital both in Milan Italy The study will evaluate the criteria and risk factors for DTT-IBD in the latest available gastroenterological examination report provided it was performed in the last 5 years from 1 January 2019
1 To evaluate the prevalence of difficult-to-treat IBD
2 To evaluate which and how demographic and clinical variables affect the risk of DTT-IBD
The subjects considered are adult patients 18 years diagnosed with UC or CD followed at San Raffaele Hospital and Humanitas Research Hospital
Crohns disease CD and ulcerative colitis UC are the two main types of chronic inflammatory bowel disease IBD Despite recent advances many patients do not respond to available treatments and or lose response over time
In 2023 the International Organisation for the Study of IBD IOIBD proposed a common definition of difficult-to-treat inflammatory bowel disease IBD-IBD to homogenise terminology and promote research into patients most in need of new treatments and therapeutic strategies According to the IOIBD criteria IBD is defined by any of the following failure of two or more advanced treatments with different mechanisms of action postoperative recurrence of Crohns disease after two or more bowel resections pouchitis refractory to antibiotics complex perianal Crohns disease or the presence of psychiatric comorbidity that prevents adequate therapeutic management
As the definition of DTT-IBD is very recent the prevalence and risk factors of DTT-IBD are not yet known This study aims to determine the prevalence of DTT-IBD in the patient population and the risk factors associated with the development of DTT-IBD The study will be conducted as a retrospective cross-sectional study in two large tertiary care centers IRCCS Ospedale San Raffaele and IRCCS Humanitas Research Hospital both in Milan Italy The study will evaluate the criteria and risk factors for DTT-IBD in the latest available gastroenterological examination report provided it was performed in the last 5 years from 1 January 2019
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None