Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-20 @ 3:33 PM
Study NCT ID:
NCT02822820
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2016-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison of Conventional and Advanced Bipolar Energy Modalities During Laparoscopic Staging Surgery of Gynecologic Cancers
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-22', 'studyFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of operation', 'timeFrame': 'six months'}, {'measure': 'Perioperative complications', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'Pain measured by Visual Analog Scale', 'timeFrame': 'Postoperative pain scores at 8th and 24th hours'}, {'measure': 'Total cost of hospitalization, operation and complications', 'timeFrame': 'six months'}]}, 'conditionsModule': {'conditions': ['Perioperative Period']}, 'referencesModule': {'references': [{'pmid': '29323616', 'type': 'DERIVED', 'citation': 'Taskin S, Sukur YE, Altin D, Turgay B, Varli B, Baytas V, Ortac F. Bipolar Energy Instruments in Laparoscopic Uterine Cancer Surgery: A Randomized Study. J Laparoendosc Adv Surg Tech A. 2018 Jun;28(6):645-649. doi: 10.1089/lap.2017.0639. Epub 2018 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'This single-institution prospective randomized clinical trial will be performed at the Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix cancer who will be operated for staging via laparoscopic approach will be included in the study. The included patients will be randomized to two groups before surgery. During the operation of first group instruments with advanced bipolar energy will be used during lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation will be performed by conventional bipolar energy forceps. The outcome parameters to be measured are intra-operative bleeding, duration of operation, intraoperative complications, postoperative pain score, postoperative complications, postoperative duration of hospitalization, late complications such as lymphocele formation and costs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologic diagnosis of endometrial or cervix cancer\n* Stage I, IB1, IIA1 cervix cancer or patients with partial or complete response to chemoradiotherapy\n* Clinically stage I and II endometrial cancer\n\nExclusion Criteria:\n\n* Hematologic abnormality\n* Coagulation disorder\n* Present or past thromboembolic disease\n* ECOG performance \\>2\n* Advanced stage disease\n* Fertility preserving surgery'}, 'identificationModule': {'nctId': 'NCT02822820', 'briefTitle': 'The Comparison of Conventional and Advanced Bipolar Energy Modalities During Laparoscopic Staging Surgery of Gynecologic Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'The Impact of Bipolar Energy Modalities on Peri-operative Outcome During Laparoscopic Staging Surgery of Gynecologic Cancers: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Advanced bipolar (Ligasure-Covidien)', 'description': 'Devices with advanced bipolar energy (Ligasure-Covidien) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy', 'interventionNames': ['Device: Ligasure-Covidien']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional bipolar (RoBi forceps-Karl Storz)', 'description': 'Devices with conventional bipolar energy (RoBi rotating bipolar forceps-Karl Storz) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy', 'interventionNames': ['Device: RoBi forceps-Karl Storz']}], 'interventions': [{'name': 'Ligasure-Covidien', 'type': 'DEVICE', 'description': 'Vessel sealing device Ligasure-Covidien used during laparoscopic hysterectomy and pelvic lymphadenectomy', 'armGroupLabels': ['Advanced bipolar (Ligasure-Covidien)']}, {'name': 'RoBi forceps-Karl Storz', 'type': 'DEVICE', 'description': 'Vessel sealing device RoBi forceps-Karl Storz used during laparoscopic hysterectomy and pelvic lymphadenectomy', 'armGroupLabels': ['Conventional bipolar (RoBi forceps-Karl Storz)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Medical Faculty Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'salih taskin', 'investigatorAffiliation': 'Ankara University'}}}}