Intraoperative Ultrasound in Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Intraoperative Ultrasound of Small Bowel in the Study of the Characteristics of the Surgical Resection Margin in Crohn's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388057
• Other study ID #: 5836
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Crohn's Disease.

Description:

Patients with indication for resective surgery for Crohn's 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 Crohn's 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 Crohn's 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 gastroenterological/surgical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 12 years or older.

• Confirmed diagnosis of Crohn's disease

• Indication for intestinal resection surgery for Crohn's Disease (first surgery or surgery for postoperative recurrence).

Exclusion Criteria:

• Patients who did not express their consent to participate in the study by signing the appropriate informed consent

• Patients younger than 12 years of age

• Patients with an indication for non-resective surgery for Crohn's Disease (e.g., ileostomy closure).

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Diagnostic Test:
• Intraoperative Small Bowel Ultrasonography
An intraoperative ultrasound study will be performed on the intestinal segment identified as the resection site

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease	To compare the number of ultrasound-positive resection margins with the number of histologically positive resection margins. This comparison will be conducted using basic statistics to determine the specificity and sensitivity of intraoperative ultrasound of the small bowel in identifying resection margins histologically involved by Crohn's disease.	10 minutes