Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT01929993
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2012-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fabiorussomano@gmail.com', 'phone': '55 21 25541815', 'title': 'Dr Fábio Russomano', 'organization': 'Fundação Oswaldo Cruz'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were observed during or through the first week after the procedures.', 'description': 'Participants at risk: the ones originally included and who received one of the procedures, no matter who had been excluded from the primary outcome analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'SWETZ', 'description': 'Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.\n\nSWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.', 'otherNumAtRisk': 81, 'otherNumAffected': 1, 'seriousNumAtRisk': 81, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'LLETZ Cone', 'description': 'LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.\n\nLLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.', 'otherNumAtRisk': 78, 'otherNumAffected': 1, 'seriousNumAtRisk': 78, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Needed general anesthesia', 'notes': 'Needed general anesthesia due to some discomfort during the procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hysterectomy', 'notes': 'Hysterectomy due to vascular injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'vaginal injury', 'notes': 'Accidental opening of the vaginal mucosa up to near the muscle layer of the bladder.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SWETZ', 'description': 'Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.\n\nSWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.'}, {'id': 'OG001', 'title': 'LLETZ Cone', 'description': 'LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.\n\nLLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one month after the procedure', 'description': 'Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Any compromised margin.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Straight Wire Excision of Transformation Zone (SWETZ)', 'description': 'Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode to remove the dysplastic epithelium of the cervix.'}, {'id': 'FG001', 'title': 'Large Loop Excision of the Transformation Zone (LLETZ-cone)', 'description': 'Large Loop Excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Absent CIN, invasion present or artifact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}], 'recruitmentDetails': 'Women who needed type 3 excision of the Transformation Zone referred to a colposcopy clinic in Rio de Janeiro, Brazil, after cytological screening between January 2008 thru December 2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Straight Wire Excision of Transformation Zone (SWETZ)', 'description': 'Straight wire excision of transformation zone (SWETZ) is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.'}, {'id': 'BG001', 'title': 'Large Loop Excision of the Transformation Zone (LLETZ-cone)', 'description': 'Large loop excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '42.3', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '43.1', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-30', 'studyFirstSubmitDate': '2012-06-10', 'resultsFirstSubmitDate': '2015-05-24', 'studyFirstSubmitQcDate': '2013-08-22', 'lastUpdatePostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-24', 'studyFirstPostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.', 'timeFrame': 'one month after the procedure', 'description': 'Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Conization', 'Cervical Intraepithelial Neoplasia', 'Cervix Dysplasia', 'Therapy', 'Electrosurgery'], 'conditions': ['Cervical Intraepithelial Neoplasia']}, 'referencesModule': {'references': [{'pmid': '25783647', 'type': 'DERIVED', 'citation': 'Russomano F, Tristao MA, Cortes R, de Camargo MJ. A comparison between type 3 excision of the transformation zone by straight wire excision of the transformation zone (SWETZ) and large loop excision of the transformation zone (LLETZ): a randomized study. BMC Womens Health. 2015;15:12. doi: 10.1186/s12905-015-0174-5. Epub 2015 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate if Straight Wire Excision of the Transformation Zone (SWETZ) is superior to (Large Loop Excision of the Transformation Zone) LLETZ cone in reducing the incomplete excision of disease.', 'detailedDescription': 'Cone biopsy is a surgical procedure which objectives the excision of endocervical pre-invasive disease located at transformation zone or glandular epithelium. Although cone biopsy is considered adequate for the treatment of endocervical dysplastic epithelium , using electrosurgery as opposed to the cold knife technique of cone biopsy has been criticized because of the perceived potential for incomplete excision of disease, thermal damage and surgical specimen fragmentation, which might increase the risk of missing early invasive cancer. Also, incomplete excision margin of disease exposes women to an increased risk of residual post-treatment disease.\n\nThe standard procedure, Large Loop Excision of the Transformation Zone (LLETZ-cone), is performed with a large loop electrode of 20-25 mm depth.\n\nThe experimental intervention is Straight Wire Excision of the Transformation Zone (SWETZ), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease.\n\nBoth procedures were previously studied in another clinical trial(NCT00995020), but the histological analysis were inconclusive for many outcomes. SWETZ were superior to LLETZ cone to acquire complete excision of disease, with no statistical significance, probably due to the small sample size.\n\nThis study objectives a better histological analyses of the surgical specimens related to incomplete excision, thermal damage and fragmentation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were eligible if the colposcopist decided that a cone biopsy was indicated.\n* Common indications for a cone biopsy included:\n\n * High-grade Squamous Intraepithelial Lesion in a type 3 transformation zone,\n * suspicion of micro-invasive or invasive carcinoma and\n * suspicion of glandular disease.\n\nExclusion Criteria:\n\n* Patients were excluded if pregnancy, coagulation disorders and cervicitis were present or if they refused to participate in the study.'}, 'identificationModule': {'nctId': 'NCT01929993', 'briefTitle': 'A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins', 'organization': {'class': 'OTHER', 'fullName': 'Oswaldo Cruz Foundation'}, 'officialTitle': 'Large Loop Excision of Transformation Zone Cone Versus Straight Wire Excision of Transformation Zone : Histopathological Analysis of Excision Margins', 'orgStudyIdInfo': {'id': '522/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SWETZ', 'description': 'Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.', 'interventionNames': ['Procedure: SWETZ']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LLETZ cone', 'description': 'LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.', 'interventionNames': ['Procedure: LLETZ cone']}], 'interventions': [{'name': 'SWETZ', 'type': 'PROCEDURE', 'otherNames': ['NETZ - Needle excision of transformation zone'], 'description': 'Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.', 'armGroupLabels': ['SWETZ']}, {'name': 'LLETZ cone', 'type': 'PROCEDURE', 'otherNames': ['LEEP - Loop electrosurgical excision procedure.'], 'description': 'LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.', 'armGroupLabels': ['LLETZ cone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22250-020', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Fernandes Figueira Institute - Oswaldo Cruz Foundation', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Maria J Camargo, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oswaldo Cruz Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oswaldo Cruz Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'MJCamargo', 'investigatorAffiliation': 'Oswaldo Cruz Foundation'}}}}