Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-04-02 @ 12:08 AM
Study NCT ID:
NCT02083003
Status:
TERMINATED
Last Update Posted:
2016-11-03
First Post:
2014-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'End of commercialization of low polyamin diet', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2014-03-07', 'studyFirstSubmitQcDate': '2014-03-07', 'lastUpdatePostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity for the 7 days', 'timeFrame': '7 days', 'description': 'Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients'}], 'secondaryOutcomes': [{'measure': 'Pain scores measured on the day of surgery,', 'timeFrame': '12 hours', 'description': 'Pain score (numerical scale from 0 to 10) measured in mid-afternoon, resting lying down, coughing and mobilization (from lying to sitting position)'}, {'measure': 'frequency of impeded hospital discharge the day of surgery', 'timeFrame': '24 hours', 'description': 'Failure of outpatient care (i.e. the patient cannot leave the hospital the day of surgery)'}, {'measure': 'Each day pain', 'timeFrame': '7 days', 'description': 'Pain scores (numerical scale from 0 to 10) assessed daily from J1 ( after surgery) to J7 in mid afternoon , lying at rest position , coughing and mobilization (from lying to sitting position) .'}, {'measure': 'Quality of life', 'timeFrame': '7 days', 'description': 'QLQC30 Questionnaire (version 3)'}, {'measure': 'Residual pain', 'timeFrame': '30 days', 'description': 'Pain score (numerical scale from 0 to 10)'}, {'measure': 'Blood levels of polyamine', 'timeFrame': '2 years', 'description': 'Blood samples are performed the day of surgery and at J7. The dosages will be performed when all patients will be recruited'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Polyamine', 'Cholecystectomy'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': "It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine) potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has shown antinociceptive properties. This research aims at evaluating analgesic properties of polyamine-low diet after laparoscopic cholecystectomy performed in an ambulatory setting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laparoscopic cholecystectomy\n* ambulatory surgery\n* agreeing to follow a polyamine-low diet with Polydol plus\n\nExclusion Criteria:\n\n* Pregnancy\n* Contra-indication to a non-steroidal anti-inflammatory, to tramadol\n* Intolerance to cow proteins\n* Diabetic patients\n* Poor understanding of the French language.'}, 'identificationModule': {'nctId': 'NCT02083003', 'briefTitle': 'Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy', 'orgStudyIdInfo': {'id': '2011/68'}, 'secondaryIdInfos': [{'id': '2011-A01675-36', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polyamine low-diet', 'description': 'Polyamines depleted diet during the week before surgery : 2 cans per day of Polydol (oral alimentation without polyamines), associated to predefined menus low in polyamines', 'interventionNames': ['Dietary Supplement: Polyamine low-diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liberal alimentation', 'description': 'No specific alimentary diet', 'interventionNames': ['Dietary Supplement: Liberal alimentation']}], 'interventions': [{'name': 'Polyamine low-diet', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Poyldol plus (Nutrialys)'], 'armGroupLabels': ['Polyamine low-diet']}, {'name': 'Liberal alimentation', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['No specific alimentary recommendation'], 'armGroupLabels': ['Liberal alimentation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'state': 'Hauts de Seine', 'country': 'France', 'facility': 'Hôpital de la Croix Saint-Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Marc Fischler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}