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Intraoperative Ultrasound in Crohn's Disease

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06388057
Enrollment
100
Registered
2024-04-29
Start date
2024-08-01
Completion date
2025-09-01
Last updated
2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

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.

Interventions

DIAGNOSTIC_TESTIntraoperative Small Bowel Ultrasonography

An intraoperative ultrasound study will be performed on the intestinal segment identified as the resection site

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Patients with Crohn's disease with an indication for surgery

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease10 minutesTo 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026