Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-29 @ 6:29 AM
Study NCT ID:
NCT02324556
Status:
TERMINATED
Last Update Posted:
2020-04-28
First Post:
2014-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A LAparoscopic and TransAnal Total Mesorectal Excision (TME) for Rectal Cancer Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Patients are currently being operated in the robot instead due to logistics', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-26', 'studyFirstSubmitDate': '2014-11-27', 'studyFirstSubmitQcDate': '2014-12-18', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of specimens with grade I specimen according to Quirke', 'timeFrame': '4 weeks postoperatively', 'description': 'Comparison with control group'}], 'secondaryOutcomes': [{'measure': 'Conversion rate', 'timeFrame': 'day of surgery'}, {'measure': 'Re-admission', 'timeFrame': '30 days'}, {'measure': 'Postoperative complications scored according to Clavien-Dindo within the first 12 months', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rectal Cancer', 'Surgery', 'Laparoscopy'], 'conditions': ['Colorectal Neoplasm']}, 'descriptionModule': {'briefSummary': 'All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed.\n\nPrimary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.', 'detailedDescription': 'The design is comparative and prospective, we will compare specimens from patients operated at our institution during the last year with standard open or laparoscopic approach with patients operated with the new technique. Patients in the control arm will be patients operated prior to the commencement of the new technique or patients not eligible or possible to include in the study.\n\nIt is possible to obtain a macroscopically and microscopically adequate specimen after a combined approach with laparoscopic and transanal TME compared to open or laparoscopic conventional TME.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Rectal cancer possible to operate with an anterior resection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presenting with a rectal cancer possible to operate with a total mesorectal excision and an anastomosis according to the local multidisciplinary conference\n* possible to operate with laparoscopic technique\n* possible to operate in regard to concomitant disease\n* giving informed consent to participate\n\nExclusion Criteria:\n\n-Participation in other trials in conflict with the protocol and end-points the LATA-trial'}, 'identificationModule': {'nctId': 'NCT02324556', 'acronym': 'LATA', 'briefTitle': 'A LAparoscopic and TransAnal Total Mesorectal Excision (TME) for Rectal Cancer Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'A LAparoscopic and TransAnal Total Mesorectal Excision (TME for Rectal Cancer Trial', 'orgStudyIdInfo': {'id': 'LATA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laparoscopic total mesorectal excision', 'description': 'Patients operated with laparoscopic total mesorectal surgery for rectal cancer'}, {'label': 'transanal total mesorectal excision', 'description': 'Patients operated with a combined transanal and laparosocopic total mesorectal surgery for rectal cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE 416 85', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Dept. of Surgery, Sahlgrenska University Hospital/Ostra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Trollhättan', 'country': 'Sweden', 'facility': 'NU-sjukvården', 'geoPoint': {'lat': 58.28365, 'lon': 12.28864}}], 'overallOfficials': [{'name': 'Eva Angenete, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska Universitetssjukhuset/Östra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant Surgeon, Associate professor', 'investigatorFullName': 'Eva Angenete', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}