Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-01-25 @ 4:17 AM
Study NCT ID:
NCT02399605
Status:
UNKNOWN
Last Update Posted:
2015-03-26
First Post:
2015-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045823', 'term': 'Ileus'}], 'ancestors': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-21', 'studyFirstSubmitDate': '2015-03-10', 'studyFirstSubmitQcDate': '2015-03-21', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first flatus', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 5 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ileus']}, 'descriptionModule': {'briefSummary': 'Assess whether the application of electrical stimulation in patients undergoing subcutaneous colon cancer in a Multimodal Rehabilitation Program (Fast track) decreases the incidence of postoperative ileus, improving the results of morbidity and mortality, hospitalization and health care costs.', 'detailedDescription': 'Prospective randomized study on the application of subcutaneous abdominal electrical stimulation in the postoperative of colonic surgery and its relationship with the appearance of postoperative ileus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing colorectal surgery.\n* Signing informed consent.\n\nExclusion Criteria:\n\n* Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)\n* Patients with contraindications for electrical stimulation.\n* Psychiatric Disorders\n* HIV\n* Pregnant or breastfeeding\n* intestinal obstruction\n* uncontrolled infection\n* ASA IV\n* No acceptance or failure to follow protocol multimodal rehabilitation.'}, 'identificationModule': {'nctId': 'NCT02399605', 'acronym': 'SESPI', 'briefTitle': 'Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Elche'}, 'officialTitle': 'Subcutaneous Electrical Stimulation in the Prevention of Postoperative Ileus in Colorectal Surgery', 'orgStudyIdInfo': {'id': 'Cirugia1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention, group control.'}, {'type': 'EXPERIMENTAL', 'label': 'Stimulation', 'description': 'Subcutaneous Electrical Intervention', 'interventionNames': ['Other: Stimulation']}], 'interventions': [{'name': 'Stimulation', 'type': 'OTHER', 'description': 'Subcutaneous abdominal electrical stimulation', 'armGroupLabels': ['Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Elche', 'state': 'Spain', 'country': 'Spain', 'facility': 'Pedro Moya', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '03203', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Pedro Moya', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}], 'overallOfficials': [{'name': 'Pedro Moya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HGU ELCHE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Elche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Pedro Moya', 'investigatorAffiliation': 'Hospital General Universitario Elche'}}}}