Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-02-26 @ 6:22 AM
Study NCT ID:
NCT02476357
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2015-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D008210', 'term': 'Lymphocele'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maurice.matter@chuv.ch', 'phone': '795561071', 'title': 'Prof. Dr Med. Maurice MATTER', 'phoneExt': '0041', 'organization': 'Lausanne University Hospita! and University of Lausanne'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Harmonic', 'description': 'Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Monopolar scalpel and ligature', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Draining Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Harmonic', 'description': 'Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)'}, {'id': 'OG001', 'title': 'Control', 'description': 'Monopolar scalpel and ligature'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '20', 'groupId': 'OG000'}, {'value': '32', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days', 'description': 'Duration (days) between surgery and removal of postoperative suction drain', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Amount of Drained Lymph', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Harmonic', 'description': 'Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)\n\nHarmonic scalpel'}, {'id': 'OG001', 'title': 'Control', 'description': 'Monopolar scalpel and ligature\n\nHarmonic scalpel'}], 'classes': [{'categories': [{'measurements': [{'value': '2908', 'spread': '2453', 'groupId': 'OG000'}, {'value': '3898', 'spread': '5791', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Lymph quantity measured every day, up to 50 days.', 'description': 'Patients had to record on a list the amount in ml. of lymph in the suction drain bottles', 'unitOfMeasure': 'ml.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient in the Harmonic group was excluded due to insufficient data collection of lymph at home'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Harmonic', 'description': 'Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)\n\nHarmonic scalpel'}, {'id': 'FG001', 'title': 'Control', 'description': 'Monopolar scalpel and ligature\n\nHarmonic scalpel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Harmonic', 'description': 'Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)'}, {'id': 'BG001', 'title': 'Control', 'description': 'Monopolar scalpel and ligature'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.7', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '61.9', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '60.8', 'spread': '14.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'unblinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Monocentric, open, interventional, randomized with two arms 1:1'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2015-02-20', 'resultsFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2015-06-18', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-28', 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Draining Time', 'timeFrame': 'Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days', 'description': 'Duration (days) between surgery and removal of postoperative suction drain'}], 'secondaryOutcomes': [{'measure': 'Daily Amount of Drained Lymph', 'timeFrame': 'Lymph quantity measured every day, up to 50 days.', 'description': 'Patients had to record on a list the amount in ml. of lymph in the suction drain bottles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lymph Node Dissection', 'Lymphoedema', 'Lymphocoele']}, 'referencesModule': {'references': [{'pmid': '28327108', 'type': 'DERIVED', 'citation': 'Gie O, Matthey-Gie ML, Marques-Vidal PM, Demartines N, Matter M. Impact of the Ultrasonic scalpel on the amount of drained lymph after axillary or inguinal lymphadenectomy. BMC Surg. 2017 Mar 21;17(1):27. doi: 10.1186/s12893-017-0222-1.'}]}, 'descriptionModule': {'briefSummary': 'Patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND, after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were randomized in a controlled trial for surgical dissection technique. Harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and oedema.', 'detailedDescription': 'The aim of the present study was to assess the value of USS in RLND in groin and axilla in a homogenous group of patients.\n\nIn a tertiary academic centre, patients undergoing groin or axillary RLND or CLND after positive SLNB for melanoma, skin cancer, sarcoma or breast cancer were enrolled in a randomized controlled trial for surgical dissection technique. The study was reviewed and accepted by the local ethical committee. Patients were older than 18 years and gave an informed consent. All patients with a past medical history of contralateral lymph node dissection or other cause of lymphedema (previous trauma, deep venous thrombosis, radiotherapy, etc.) were excluded. Patients undergoing both iliac and inguinal lymph node dissections were excluded as well. No patients had distant or in transit metastasis. Patients were randomly assigned using sealed numbered envelopes to one of two arms of the study in a 1: 1 ratio. In the first group the dissection was conducted with USS (Harmonic Focus ®, Ethicon Endo-Surgery (Europe) GmbH) exclusively. In the control group the lymphadenectomy was performed using ligation and monopolar electrocautery. All patients were operated by a dedicated team headed by a single surgeon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND), after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were included.\n\nExclusion Criteria:\n\n* Patient with a past medical history of contralateral lymph node dissection or other cause for lymphedema (trauma, deep venous thrombosis, radiotherapy, etc.) were excluded.'}, 'identificationModule': {'nctId': 'NCT02476357', 'briefTitle': 'A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'A Randomized Control Trial for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection', 'orgStudyIdInfo': {'id': 'LYMPH-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Harmonic', 'description': 'Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)', 'interventionNames': ['Device: Harmonic scalpel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Monopolar scalpel and ligature', 'interventionNames': ['Device: Harmonic scalpel']}], 'interventions': [{'name': 'Harmonic scalpel', 'type': 'DEVICE', 'armGroupLabels': ['Control', 'Harmonic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Department of Visceral Surgery, University Hospital Center', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Maurice Matter, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Lausanne Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nicolas DEMARTINES', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}