Crohn DiseaseNCT06388057
Intraoperative Ultrasound in Crohn's Disease
A study testing Intraoperative Small Bowel Ultrasonography in people with Crohn Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Intraoperative Small Bowel Ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
About this study
Official title: Intraoperative Ultrasound of Small Bowel in the Study of the Characteristics of the Surgical Resection Margin in Crohn's Disease
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- Intraoperative Small Bowel Ultrasonography
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Small Bowel UltrasonographyDiagnostic test
An intraoperative ultrasound study will be performed on the intestinal segment identified as the resection site
| Study group | Role | What they receive |
|---|---|---|
| Patients with Crohn's disease with indication for surgery | Experimental | Not described Receives: Diagnostic Test: Intraoperative Small Bowel Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with Crohn's disease with an indication for surgery
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388057
- Sponsor's protocol ID
- 5836
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Ultrasound of Small Bowel in the Study of the Characteristics of the Surgical Resection Margin in Crohn's Disease
- ClinicalTrials.gov ID
- NCT06388057
- Acronym / sponsor ID
- 5836
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with Crohn's disease with an indication for surgery
| Arm | Type | Receives |
|---|---|---|
| Patients with Crohn's disease with indication for surgery | Experimental | Diagnostic Test: Intraoperative Small Bowel Ultrasonography |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Small Bowel UltrasonographyAn intraoperative ultrasound study will be performed on the intestinal segment identified as the resection site | Diagnostic test | Patients with Crohn's disease with indication for surgery |
Primary outcome
Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease
Time frame: 10 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Small Bowel Ultrasonography in people with Crohn Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.