Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:30 PM
Study NCT ID:
NCT05682794
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2022-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2502}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-27', 'studyFirstSubmitDate': '2022-12-27', 'studyFirstSubmitQcDate': '2022-12-27', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival rate', 'timeFrame': '5 years after the surgery'}, {'measure': 'disease-free survival ratev', 'timeFrame': '5 years after the surgery'}], 'secondaryOutcomes': [{'measure': 'Local recurrence rate', 'timeFrame': '3 years after the surgery', 'description': 'Local recurrence was defined as radiologic or histopathologic evidence of any recurrent disease deposit located in the pelvis in the prior area of dissection following a primary rectal cancer resection, with or without distal metastasis'}, {'measure': 'Cancer special survival rate', 'timeFrame': '5 years after the surgery', 'description': 'Cancer special survival was defined as the time from the date of primary rectal cancer resection to the date of death caused by rectal cancer.'}, {'measure': 'Quality of the mesorectum specimen', 'timeFrame': '30 days after the surgery', 'description': 'The quality of the resected mesorectum was classified into three grades: (a) incomplete, (b) nearly complete, and (c) complete'}, {'measure': 'CRM status', 'timeFrame': '30 days after the surgery', 'description': 'The CRM was regarded as positive if the tumor distance or malignant lymph node to CRM was ≦1 mm.'}, {'measure': 'DRM status', 'timeFrame': '30 days after the surgery', 'description': 'The DRM was regarded as positive if it was microscopically involved by or ≦1 mm from the tumor margins.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal cancer', 'taTME', 'Local recurrence'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '38091943', 'type': 'DERIVED', 'citation': 'Li Z, Liu H, Luo S, Hou Y, Zhou Y, Zheng X, Zhang X, Huang L, Zeng Z, Kang L. Long-term oncological outcomes of transanal versus laparoscopic total mesorectal excision for mid-low rectal cancer: a retrospective analysis of 2502 patients. Int J Surg. 2024 Mar 1;110(3):1611-1619. doi: 10.1097/JS9.0000000000000992.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the long-term oncology outcomes and specimen quality of taTME and laTME in the treatment of middle and low rectal cancer by a large sample cohort. At the same time, the local recurrence following a primary rectal cancer resection was analyzed to respond to the concerns about the event of the national suspension for TaTME due to the high local recurrence rate in Norway.', 'detailedDescription': 'Laparoscopic surgery is considered to have better visualization for more accurate separation and further injury reduction than open surgery. However, the oncology outcomes are still controversial. Especially in the challenging patients who have narrow and deep pelvic, the disadvantage that it is difficult to obtain high-quality resected specimens during laparoscopic TME (laTME) surgery is considered to be magnified. It is considered transanal total mesorectal excision (taTME) is an alternative method to solve this "old problem". However, as a new technology that has been around for only 10 years, the applicability of taTME worldwide needs to be further proved in long-term oncology. This prospective cohort study aimed to compare taTME surgery to laTME surgery for mid and low-rectal cancer on long-term oncology outcomes from a single, experienced Chinese center that was an early adopter of taTME.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Low-mid rectal cancer within Stage III.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 80 years old\n2. Confirmed rectal adenocarcinoma cancer pathologically\n3. Tumor location ≦ 12 cm from the anal margin\n4. Willing and able to provide written informed consent for participation in this study\n\nExclusion Criteria:\n\n1. Distant metastasis before surgery\n2. More than one colorectal tumor at diagnosis\n3. Familial adenomatous polyposis\n4. Recurrent rectal cancer\n5. Undergo transanal minimally invasive surgery\n6. Undergo palliative treatment\n7. Undergo emergency surgery'}, 'identificationModule': {'nctId': 'NCT05682794', 'briefTitle': 'Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort', 'orgStudyIdInfo': {'id': 'GIHSYSU-32'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'taTME', 'description': 'patients who underwent transanal total mesorectal excision', 'interventionNames': ['Procedure: transanal total mesorectal excision']}, {'label': 'laTME', 'description': 'patients who underwent laparoscopic total mesorectal excision'}], 'interventions': [{'name': 'transanal total mesorectal excision', 'type': 'PROCEDURE', 'otherNames': ['laparoscopic total mesorectal excision'], 'description': 'transanal TME', 'armGroupLabels': ['taTME']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Liang Kang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data can be obtained with a proper request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yanhong Deng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}