Intraoperative Ultrasound in Crohn's Disease

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Not yet enrolling

Conditions

Crohn Disease

Treatments

Diagnostic Test: Intraoperative Small Bowel Ultrasonography

Study type

Interventional

Funder types

Other

Identifiers

NCT06388057

5836

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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).