Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638814
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
HEmorrhoidAl Disease in Inflammatory Bowel Disease a Multicenter Prospective Cohort Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HEmorrhoidAl Disease in Inflammatory Bowel Disease a Multicenter Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
HEAD-IBD-II
Brief Summary:
Patients who will undergo surgery for HD after the diagnosis of IBD over a 12-month period will be enrolled across Europe
Primary objective of this study is to determine the safety and effectiveness of surgical treatments for HD in a large multicenter cohort of IBD patients
Secondary aim is to identify factors that may affect clinical and surgical outcomes
Primary objective of this study is to determine the safety and effectiveness of surgical treatments for HD in a large multicenter cohort of IBD patients
Secondary aim is to identify factors that may affect clinical and surgical outcomes
Detailed Description:
To date there is no consensus in the scientific literature regarding the exact indications for surgery for hemorrhoidal disease HD in patients with inflammatory bowel disease IBD The HEAD-IBD-II study is a multicenter prospective cohort designed to evaluate the safety and effectiveness of surgical treatments for hemorrhoidal disease HD in patients with inflammatory bowel disease IBD This study aims to collect contemporary real-world data from multiple hospitals across various countries focusing on the surgical management of HD in this unique patient population The study will include adult patients with a confirmed diagnosis of Crohns disease or ulcerative colitis who undergo surgery for HD
The data collection process will involve detailed records of patient demographics pre-operative status operative techniques and post-operative outcomes with a specific focus on short- medium- and long-term surgical and clinical results The study will track outcomes such as postoperative complications recurrence of symptoms IBD flare-ups and anal continence
In addition factors such as surgical volume techniques employed and individual patient characteristics will be analyzed to identify variables that may impact the outcomes The study is designed to generate hypotheses and explore variability in current practices thereby highlighting areas in need of further investigation through randomized controlled trials
All patient data will be collected anonymously through a secure electronic case report form eCRF and results will be disseminated according to the STROBE guidelines for observational studies Ethical approval will be obtained from participating institutions and all patients will provide informed consent prior to inclusion The study is expected to improve the understanding of surgical approaches to HD in IBD patients and potentially guide future clinical recommendations
The data collection process will involve detailed records of patient demographics pre-operative status operative techniques and post-operative outcomes with a specific focus on short- medium- and long-term surgical and clinical results The study will track outcomes such as postoperative complications recurrence of symptoms IBD flare-ups and anal continence
In addition factors such as surgical volume techniques employed and individual patient characteristics will be analyzed to identify variables that may impact the outcomes The study is designed to generate hypotheses and explore variability in current practices thereby highlighting areas in need of further investigation through randomized controlled trials
All patient data will be collected anonymously through a secure electronic case report form eCRF and results will be disseminated according to the STROBE guidelines for observational studies Ethical approval will be obtained from participating institutions and all patients will provide informed consent prior to inclusion The study is expected to improve the understanding of surgical approaches to HD in IBD patients and potentially guide future clinical recommendations
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