Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-18 @ 12:45 PM
Study NCT ID:
NCT03826251
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2019-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Small Bowel Obstruction and Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative morbidity', 'timeFrame': 'within 30 days', 'description': 'morbidity classified according to Dindo Clavien classification'}], 'secondaryOutcomes': [{'measure': 'Nasogastric tube replacement', 'timeFrame': 'within 30 days', 'description': 'nasogastric tube replacement after removal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Small Intestine Obstruction']}, 'descriptionModule': {'briefSummary': 'Postoperative management after small bowel obstruction (SBO) surgery is not consensual and better knowledge of risk factors for postoperative morbidity could help to add evidence of the feasibility of enhanced recovery programs (ERPs).\n\nIn elective surgery, ERPs have shown a significant benefit for the patient but this is not performed routinely in emergency surgery due to the difficulty to avoid postoperative nasogastric tube.\n\nThe aim was to identify risk factors for postoperative morbidity and for nasogastric tube (NGT) replacement after SBO surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing surgery for adhesive small bowel obstruction in the CHU of Angers between January 1, 2014 and December 31, 2017', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical management of Small bowel obstruction due to adhesions\n\nExclusion Criteria:\n\n* obstruction not caused by single band adhesion\n* matted adhesions, or if they were less than 18 years old'}, 'identificationModule': {'nctId': 'NCT03826251', 'briefTitle': 'Small Bowel Obstruction and Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Nasogastric Tube After Small Bowel Obstruction Surgery is Not Mandatory: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'UH Angers 2018/75'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'systematic nasogastric tube', 'description': 'NGT was left systematically after surgery and removed after the first flattus'}, {'label': 'Non systematic nasogastric tube', 'description': 'Nasogastric tube was removed immediately after surgery and was replaced in case of vomiting', 'interventionNames': ['Procedure: Nasogastric tube removal']}], 'interventions': [{'name': 'Nasogastric tube removal', 'type': 'PROCEDURE', 'description': 'Nasogastric tube was removed immediately after surgery', 'armGroupLabels': ['Non systematic nasogastric tube']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}