Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-11-06
Brief Title:
Intraoperative Ultrasound in Crohns Disease
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Intraoperative Ultrasound of Small Bowel in the Study of the Characteristics of the Surgical Resection Margin in Crohns Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
To study the role of intraoperative ultrasound of small bowel as a possible tool that can reduce the rate of histologically involved resection margins from Crohns Disease
Detailed Description:
Patients with indication for resective surgery for Crohns Disease will be enrolled and undergo to the planned surgery
During surgery the site where to conduct the bowel resection will be decided according to the current indications in the literature and according to good clinical practice absence of macroscopical signs of disease
Before conducting the surgical resection will be performed intraoperative ultrasonography of the small bowel at the intestinal segment chosen as the site of the resection
Ultrasound features will be evaluated to determine whether or not there are any ultrasonographic signs ascribable to Crohns Disease
Once the above ultrasound has been completed estimated time approximately 5-10 minutes the predetermined resection will be conduct and the surgical piece will be sent for final histological examination as usual
The outcome of intraoperative ultrasound will be schematized as positive or negative based on the presence or absence of specific ultrasound signs of intestinal inflammation attributable to Crohns Disease
The data will be collected and subsequently analyzed in order to compare the ultrasound findings acquired on the resection margins with the outcome of the histological examination conducted on the same site
Patients will then enter a regular gastroenterologicalsurgical follow-up and undergo colonoscopy at 12 months after surgery as usual
Data on clinical surgical or endoscopic recurrence in the follow-up period will be collected and analyzed to compare the recurrence rate in the group of patients with intraoperative ultrasonographic features with the group without intraoperative ultrasonographic features on the resection margin
During surgery the site where to conduct the bowel resection will be decided according to the current indications in the literature and according to good clinical practice absence of macroscopical signs of disease
Before conducting the surgical resection will be performed intraoperative ultrasonography of the small bowel at the intestinal segment chosen as the site of the resection
Ultrasound features will be evaluated to determine whether or not there are any ultrasonographic signs ascribable to Crohns Disease
Once the above ultrasound has been completed estimated time approximately 5-10 minutes the predetermined resection will be conduct and the surgical piece will be sent for final histological examination as usual
The outcome of intraoperative ultrasound will be schematized as positive or negative based on the presence or absence of specific ultrasound signs of intestinal inflammation attributable to Crohns Disease
The data will be collected and subsequently analyzed in order to compare the ultrasound findings acquired on the resection margins with the outcome of the histological examination conducted on the same site
Patients will then enter a regular gastroenterologicalsurgical follow-up and undergo colonoscopy at 12 months after surgery as usual
Data on clinical surgical or endoscopic recurrence in the follow-up period will be collected and analyzed to compare the recurrence rate in the group of patients with intraoperative ultrasonographic features with the group without intraoperative ultrasonographic features on the resection margin
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