Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT05517057
Status:
COMPLETED
Last Update Posted:
2022-08-26
First Post:
2022-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiologic Score and Failure of Conservative Management of Adhesive Small Bowel Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2022-08-20', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angers CT score', 'timeFrame': 'immediately after the completion of the CT-scan', 'description': 'The Angers CT score ≥5 was considered to be risk factor for failure of the medical management.\n\nAngers CT score was calculated by reading the CT scan as follow:\n\n* beak sign (+2), if not (0)\n* closed loop (+4), if not (0)\n* focal (+4) or diffuse (+4) intraperitoneal liquid, if not (0)\n* focal (+2) or diffuse (0) mesenteric haziness, if not (0)\n* focal (-3) or diffuse (-3) mesenteric liquid, if not (0)\n* diameter of the most dilated small bowel loop \\> 40 mm (-2) (if not (0).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small Bowel Obstruction', 'Conservative Management', 'Imaging']}, 'descriptionModule': {'briefSummary': 'The management of acute adhesive small bowel obstruction remains challenging for the digestive surgeon. The Bologna guidelines recommend that conservative management of aSBO. The literature reports that this form of management has a failure rate between 10 and 40%.\n\nA radiological score has been proposed and was associated with an increased risk of failure of conservative management.\n\nThis tool is promising to select patients further requiring surgery but it has to be assessed in a multi centric prospective cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was an observational multicentric cohort study including all the consecutive patients admitted for initial non-surgical management for aSBO. The study took place over a period of 3 months (September 15 - December 15, 2021) in 15 French centers.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all the consecutive patients admitted for initial non-surgical management for aSBO\n* during the period of inclusion\n\nExclusion Criteria:\n\n* the cause of SBO was functional or other than adhesive\n* patients requiring initial surgical management.\n* absence of computed tomography performed at admission'}, 'identificationModule': {'nctId': 'NCT05517057', 'acronym': 'PREDIFAIL', 'briefTitle': 'Radiologic Score and Failure of Conservative Management of Adhesive Small Bowel Obstruction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Assessment of a Predictive Radiologic Score to Predict the Failure of the Non-operative Management of Adhesive Small Bowel Obstruction: a Prospective Cohort Analysis', 'orgStudyIdInfo': {'id': '2021-099'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'success of the medical management', 'description': 'Patients that recovered flatus and stools, and that tolerated solid food within the 3 days after the admission'}, {'label': 'failure of the medical management', 'description': 'Patients that did not recover flatus and stools, and that did not tolerate solid food within the 3 days after the admission. These patients had an indication for surgery.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'university hospital of Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}