Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-18 @ 3:40 PM
Study NCT ID:
NCT01881594
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2013-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stimulation of Efferent Loop Prior to Ileostomy Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2013-04-29', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative ileus', 'timeFrame': 'within the first days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ileostomy closure,postoperative ileus,stimulation ileostomy'], 'conditions': ['Ileostomy; Complications']}, 'referencesModule': {'references': [{'pmid': '25380005', 'type': 'DERIVED', 'citation': 'Abrisqueta J, Abellan I, Lujan J, Hernandez Q, Parrilla P. Stimulation of the efferent limb before ileostomy closure: a randomized clinical trial. Dis Colon Rectum. 2014 Dec;57(12):1391-6. doi: 10.1097/DCR.0000000000000237.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare postoperative ileus between stimulated and unstimulated patients prior to ileostomy closure.', 'detailedDescription': 'Stimulation was performed ten days prior to the intervention, through the efferent limb of the ileostomy with 500 cc of a thickening substance (saline and nutritional thickener)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* protective ileostomy after rectal cancer surgery\n\nExclusion Criteria:\n\n* under 18 years'}, 'identificationModule': {'nctId': 'NCT01881594', 'briefTitle': 'Stimulation of Efferent Loop Prior to Ileostomy Closure', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Virgen de la Arrixaca'}, 'orgStudyIdInfo': {'id': 'SEL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No stimulation', 'description': 'unstimulated patients prior to surgery,ileostomy closure surgery without prior stimulation of efferent limb.', 'interventionNames': ['Procedure: Procedure/Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Stimulation', 'description': 'stimulation of the efferent limb of the ileostomy prior to ileostomy closure.', 'interventionNames': ['Procedure: Procedure/Surgery']}], 'interventions': [{'name': 'Procedure/Surgery', 'type': 'PROCEDURE', 'otherNames': ['Stimulation'], 'description': 'daily stimulation of efferent loop prior to surgery (ileostomy closure)', 'armGroupLabels': ['No stimulation', 'Stimulation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Virgen de la Arrixaca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Section chief. Coloproctology department.', 'investigatorFullName': 'Juan Lujan', 'investigatorAffiliation': 'Hospital Universitario Virgen de la Arrixaca'}}}}