Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT02815956
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tibial Nerve Stimulation and Postoperative Ileus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-30', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-06-23', 'lastUpdatePostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delay before solid food tolerance and first stool recovery (expressed in days afters surgery). Day 0 (D0) is the day of surgery.', 'timeFrame': 'data collected from 6 hours after the end of surgery to the recovery. This recovery is expected to be between 1 and 6 days after surgery. Recovery will be assessed 3 times a day (7.00 am, 12.00 am, 6.00 pm)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['percutaneous tibial nerve stimulation', 'randomized', 'controlled study'], 'conditions': ['Postoperative Ileus']}, 'descriptionModule': {'briefSummary': "Postoperative ileus (POI) causes patient's discomfort and leads to an increase of cost of management after colorectal surgery because of an increase of the morbidity rate or of the rate of early rehospitalization after discharge.\n\nEnhanced recovery programs allowed a reduction of its rate but 20 to 30% of patients will experiment POI.\n\nA new approach during preoperative era, using mastication or preoperative physical activity, has been proposed to improve postoperative course. This leads to a vagal activation (action especially on upper GI).\n\nSacral stimulation using percutaneous tibial nerve stimulation (PTNS) has an effect on lower GI.\n\nThe aim of this study was to assess the efficacy and the feasibility of PTNS during perioperative course, to prevent POI with respect with placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients \\> 18 years\n* elective colectomy or proctectomy\n* agreement for the research\n\nExclusion Criteria:\n\n* chronic inflammatory bowel disease\n* irritable bowel disease documented\n* history of surgery on oesophagus or stomach\n* acetylcholine dysfunction\n* enterostoma\n* patient holder of pace-maker'}, 'identificationModule': {'nctId': 'NCT02815956', 'acronym': 'pre-TAPIOCA', 'briefTitle': 'Tibial Nerve Stimulation and Postoperative Ileus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'InteresT And Mechanisms of Percutaneous Posterior tIbial Nerve Stimulation to Prevent pOstoperative Ileus in ColorectAl Surgery: A Preliminary Study', 'orgStudyIdInfo': {'id': '2016-A00438-43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'percutaneous tibial nerve stimulation (ST)', 'description': 'Stimulation the day before surgery (x1), 30 minutes Stimulation the day of surgery, before surgery (at least 2 hours before surgery) and after surgery.\n\nStimulation every day (x3) after surgery until gastrointestinal functions recovery.\n\nThe protocol of stimulation is the same, that the one performed for fecal incontinence.', 'interventionNames': ['Device: percutaneous tibial nerve stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo (P)', 'description': 'Stimulation the day before surgery (x1), 30 minutes Stimulation the day of surgery, before surgery (at least 2 hours before surgery) and after surgery.\n\nStimulation every day (x3) after surgery until gastrointestinal functions recovery.\n\nThe device delivers ineffective impulses.', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'percutaneous tibial nerve stimulation', 'type': 'DEVICE', 'armGroupLabels': ['percutaneous tibial nerve stimulation (ST)']}, {'name': 'Placebo', 'type': 'DEVICE', 'armGroupLabels': ['placebo (P)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'University Hospital Center', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Aurélien Venara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Center of Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}