Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-02 @ 10:24 AM
Study NCT ID:
NCT01974193
Status:
UNKNOWN
Last Update Posted:
2015-02-11
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-06-29', 'releaseDate': '2022-07-26'}], 'estimatedResultsFirstSubmitDate': '2022-07-26'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C411004', 'term': 'FloSeal Matrix'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-10', 'studyFirstSubmitDate': '2013-10-28', 'studyFirstSubmitQcDate': '2013-10-31', 'lastUpdatePostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of pelvic lymphocele', 'timeFrame': '6 month', 'description': 'Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.'}], 'secondaryOutcomes': [{'measure': 'Post-operative drainage', 'timeFrame': 'post-operative 3 days', 'description': 'left and right post-operative drainage'}, {'measure': 'lymphedema', 'timeFrame': 'post-operative 3 and 6 month', 'description': 'lymphedema symptoms and sign at post-operative 3 and 6 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gynecologic Cancer']}, 'descriptionModule': {'briefSummary': 'Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies.\n\nSometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment.\n\nA number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND.\n\nThe investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND.\n\nThe investigators designed prospective randomized controlled study as a pilot study.\n\nThe investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Gynecologic cancer patients who need laparotomic bilateral PLND\n\nExclusion Criteria:\n\n* Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)"}, 'identificationModule': {'nctId': 'NCT01974193', 'briefTitle': 'Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University Mokdong Hospital'}, 'officialTitle': 'Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study', 'orgStudyIdInfo': {'id': 'BFL01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Floseal', 'description': 'application of floseal to one side of pelvis after pelvic lymphadenectomy', 'interventionNames': ['Drug: Floseal']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'counter-site of pelvis; no intervention after pelvic lymphadenectomy'}], 'interventions': [{'name': 'Floseal', 'type': 'DRUG', 'description': 'application of floseal on intervention arm', 'armGroupLabels': ['Floseal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '158-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yun Hwan Kim, Dr', 'role': 'CONTACT', 'email': 'medok74@gmail.com', 'phone': '+82-10-9096-7875'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University Mokdong Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yun Hwan KIM', 'investigatorAffiliation': 'Ewha Womans University Mokdong Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-07-26', 'type': 'RELEASE'}, {'date': '2023-06-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yun Hwan KIM, Assistant Professor, Ewha Womans University Mokdong Hospital'}}}}