Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT03765320
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2018-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008210', 'term': 'Lymphocele'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-19', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Factors predicting lymphocele occurrence', 'timeFrame': '10 year', 'description': 'To find independent factors that can predict lymphocele occurrence in patients who underwent laparotomic gynecologic oncologic surgery'}], 'secondaryOutcomes': [{'measure': 'Factors predicting surgical complication', 'timeFrame': '10 years', 'description': 'To find independent factors that can predict occurrence of surgical complication in patients who underwent laparotomic gynecologic oncologic surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphocele', 'Gynecologic Cancer']}, 'descriptionModule': {'briefSummary': 'To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection.', 'detailedDescription': 'To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection by reviewing the medical records of patients who underwent retroperitoneal lymph node dissection for stage I or II gynecological cancer in Far Eastern Memorial Hospital, January 2011\\~December 2017.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Early gynecologic cancer patients who underwent retroperitoneal lymph node dissection in Far Eastern Memorial Hospital between January 2011 and December 2017.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage I or stage II gynecologic cancer (including cervical cancer, endometrial cancer, ovarian cancer, and fallopian tube cancer)\n* Underwent laparotomic gynecologic oncologic surgery, including retroperitoneal lymphadenectomy.\n\nExclusion Criteria:\n\n* nil'}, 'identificationModule': {'nctId': 'NCT03765320', 'briefTitle': 'Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection for Early Gynecological Cancer', 'orgStudyIdInfo': {'id': '107150-E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Peritoneal closure', 'type': 'PROCEDURE', 'description': 'Peritoneal closure after pelvic lymph node dissection for early gynecologic cancer'}, {'name': 'Retroperitoneal drainage', 'type': 'PROCEDURE', 'description': 'Retroperitoneal drainage after pelvic lymph node dissection for early gynecologic cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22050', 'city': 'Banqiao District', 'state': 'New Taipei', 'country': 'Taiwan', 'facility': 'Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Department of Obstetrics & Gynecology', 'investigatorFullName': 'Sheng-Mou Hsiao', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}