Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-29 @ 5:15 PM
Study NCT ID:
NCT06388057
Status:
UNKNOWN
Last Update Posted:
2024-06-14
First Post:
2023-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Ultrasound in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "Patients with Crohn's disease with an indication for surgery"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2024-04-24', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease", 'timeFrame': '10 minutes', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Patients with indication for resective surgery for Crohn's Disease will be enrolled and undergo to the planned surgery.\n\nDuring 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).\n\nBefore conducting the surgical resection, will be performed intraoperative ultrasonography of the small bowel at the intestinal segment chosen as the site of the resection.\n\nUltrasound features will be evaluated to determine whether or not there are any ultrasonographic signs ascribable to Crohn's Disease.\n\nOnce 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.\n\nThe 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.\n\nThe 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.\n\nPatients will then enter a regular gastroenterological/surgical follow-up and undergo colonoscopy at 12 months after surgery as usual.\n\nData 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 12 years or older.\n* Confirmed diagnosis of Crohn's disease\n* Indication for intestinal resection surgery for Crohn's Disease (first surgery or surgery for postoperative recurrence).\n\nExclusion Criteria:\n\n* Patients who did not express their consent to participate in the study by signing the appropriate informed consent\n* Patients younger than 12 years of age\n* Patients with an indication for non-resective surgery for Crohn's Disease (e.g., ileostomy closure)."}, 'identificationModule': {'nctId': 'NCT06388057', 'briefTitle': "Intraoperative Ultrasound in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': "Intraoperative Ultrasound of Small Bowel in the Study of the Characteristics of the Surgical Resection Margin in Crohn's Disease", 'orgStudyIdInfo': {'id': '5836'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Patients with Crohn's disease with indication for surgery", 'interventionNames': ['Diagnostic Test: Intraoperative Small Bowel Ultrasonography']}], 'interventions': [{'name': 'Intraoperative Small Bowel Ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'An intraoperative ultrasound study will be performed on the intestinal segment identified as the resection site', 'armGroupLabels': ["Patients with Crohn's disease with indication for surgery"]}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}