Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-20 @ 1:43 PM
Study NCT ID:
NCT01847703
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2013-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Versus Abdominal Surgery for Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065287', 'term': 'Robotic Surgical Procedures'}], 'ancestors': [{'id': 'D025321', 'term': 'Surgery, Computer-Assisted'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D012371', 'term': 'Robotics'}, {'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2013-05-02', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of harvested lymph nodes', 'timeFrame': '2 years', 'description': 'Extracted lymphatic tissue from 3 stations (above inferior mesenteric artery, below inferior mesenteric artery, pelvic) is analysed by a pathologist and the number of nodes for each station recorded and compared between the two groups'}], 'secondaryOutcomes': [{'measure': 'Recurrence of cancer', 'timeFrame': '3 years', 'description': 'Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site'}, {'measure': 'Lymphatic side-effects', 'timeFrame': '2 years', 'description': 'Lymphatic side-effects will be monitored by repeated computed tomography (CT) 3 months and 12 months after surgery. Enrolled women will be asked specific, validated questions at follow-up'}, {'measure': 'Quality of life', 'timeFrame': '2 years', 'description': 'All included participants will be asked to fill out a questionnaire (EORTC) to assess quality of life before and 1 year after surgery'}, {'measure': 'Healthcare cost', 'timeFrame': '2 years', 'description': 'All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endometrial Neoplasms']}, 'referencesModule': {'references': [{'pmid': '28463759', 'type': 'DERIVED', 'citation': 'Salehi S, Avall-Lundqvist E, Legerstam B, Carlson JW, Falconer H. Robot-assisted laparoscopy versus laparotomy for infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer: A randomised controlled trial. Eur J Cancer. 2017 Jul;79:81-89. doi: 10.1016/j.ejca.2017.03.038. Epub 2017 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'This study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.', 'detailedDescription': 'Hypothesis: Robotic assisted laparoscopy (RAL)is equal in terms of oncologic and surgical safety as conventional abdominal surgery (AS) for high risk endometrial cancer (EC).\n\nMethods: Women with high risk EC (defined as high grade endometrial, clear cell or serous) are randomized to either RAL or AS. Both groups will undergo complete surgical staging (hysterectomy, bilateral salpingoophorectomy, pelvic and paraaortal lymphadenectomy)\n\nPrimary endpoint: Number of harvested lymph nodes per station Secondary endpoints: Recurrences up to 3 year after surgery. Lymphatic side-effects, quality of life, cost, surgical morbidity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years of age\n* High risk endometrial cancer\n\nExclusion Criteria:\n\n* WHO performance\\>1\n* Severe comorbidity, ASA\\>3\n* Unable to understand information'}, 'identificationModule': {'nctId': 'NCT01847703', 'acronym': 'RASHEC', 'briefTitle': 'Robotic Versus Abdominal Surgery for Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer', 'orgStudyIdInfo': {'id': '2013/361-31/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic surgery', 'description': 'Experimental method, to be compared with standard care', 'interventionNames': ['Procedure: Robotic surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abdominal surgery', 'description': 'Conventional open surgery (laparotomy)', 'interventionNames': ['Procedure: Abdominal surgery']}], 'interventions': [{'name': 'Robotic surgery', 'type': 'PROCEDURE', 'description': 'Minimal invasive surgery performed with daVinci robotic system', 'armGroupLabels': ['Robotic surgery']}, {'name': 'Abdominal surgery', 'type': 'PROCEDURE', 'description': 'Current gold standard', 'armGroupLabels': ['Abdominal surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Henrik Falconer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Henrik Falconer', 'investigatorAffiliation': 'Karolinska Institutet'}}}}