Clinical trial NCT06388057: Intraoperative Ultrasound in Crohn's Disease
Official title: Intraoperative Ultrasound of Small Bowel in the Study of the Characteristics of the Surgical Resection Margin in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with Crohn's disease with an indication for surgery
Primary purpose: DIAGNOSTIC

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 Crohn's Disease.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: