Intraoperative Ultrasound in Crohn's Disease

NCT06388057 | Unknown

• 1 other identifier: 5836
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with Crohn's disease with indication for surgery

EXPERIMENTAL

Diagnostic Test: Intraoperative Small Bowel Ultrasonography

Interventions

Intraoperative Small Bowel Ultrasonography DIAGNOSTIC_TEST

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

Patients with Crohn's disease with indication for surgery

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with Crohn's disease with an indication for surgery

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: April 29, 2024
• Study Start: August 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: September 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2023-11