Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407674
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
Non-invasive Assessment of RECTUM POUCH by US RECT-US in a Cohort of IBD Patients
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Non-invasive Assessment of RECTUM POUCH by US RECT-US Multicentric Observational and Cross-sectional Comparison Study With Colonoscopy in a Cohort of IBD Patients
Status:
RECRUITING
Status Verified Date:
2024-05
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:
RECT-US
Brief Summary:
At enrollment after informed consent form will be discussed and signed subjects will undergo complete disease assessment
In this study 150 adult subjects with IBD will be enrolled at the Gastroenterology Department of the San Raffaele Hospital 50 patients with Crohns disease 50 with Ulcerative colitis not undergoing proctocolectomy and 50 with Ulcerative colitis undergoing proctocolectomy with ileal pouch-anal anastomosis
All the patients will perform routine investigations with Ileocolonoscopy IC according to the current standard of care indications and ECCO guidelines and they will be assessed by both Intestinal Ultrasound IUS and Trans-perineal ultrasound TPUS Blood and stool samples will be obtained for fecal calprotectin FC and C-reactive protein CRP measurements respectively as normal clinical practice
All the procedures of this study are performed routinely in clinical practice All the procedures are performed in a single day-visit for the patient
In this study 150 adult subjects with IBD will be enrolled at the Gastroenterology Department of the San Raffaele Hospital 50 patients with Crohns disease 50 with Ulcerative colitis not undergoing proctocolectomy and 50 with Ulcerative colitis undergoing proctocolectomy with ileal pouch-anal anastomosis
All the patients will perform routine investigations with Ileocolonoscopy IC according to the current standard of care indications and ECCO guidelines and they will be assessed by both Intestinal Ultrasound IUS and Trans-perineal ultrasound TPUS Blood and stool samples will be obtained for fecal calprotectin FC and C-reactive protein CRP measurements respectively as normal clinical practice
All the procedures of this study are performed routinely in clinical practice All the procedures are performed in a single day-visit for the patient
Detailed Description:
None
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