Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT06147492
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2023-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D016055', 'term': 'Urinary Retention'}], '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'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 526}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-11-22', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urinary retention', 'timeFrame': '30 days', 'description': 'urinary retention rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urinary retention'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'A comprehensive study with prospectively collected data. These patients were assigned to either the taTME group or the laTME group according to the surgery procedure received', 'detailedDescription': 'Transanal total mesorectal excision has emerged as a potential solution to certain limitations associated with laparoscopic total mesorectal excision in rectal cancer patients. Differences in surgical approaches have raised questions regarding their impact on the risk of postoperative urinary retention, with limited data available from large scale study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range from 18 to 65 years,\n* Diagnosed with rectal cancer at clinical tumor node metastasis stages II or III.\n* Palpable tumor determined by digital rectal examination or proctoscopy\n* The distal border of the tumor located within 12 cm from the anal verge\n\nExclusion Criteria:\n\n* Patients presenting clear indications of pelvic side wall involvement or distant metastasis\n* Uncontrolled hypertension or cardiovascular disease\n* Patients with synchronous colon cancer\n* History of other malignancies within the past 5 years'}, 'identificationModule': {'nctId': 'NCT06147492', 'briefTitle': 'Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Urinary Retention Following Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer', 'orgStudyIdInfo': {'id': 'GIH-SYip66'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'laTME', 'description': 'Laparoscopic Total Mesorectal Excision', 'interventionNames': ['Procedure: Laparoscopic Total Mesorectal Excision']}, {'type': 'OTHER', 'label': 'taTME', 'description': 'a transanal bottom-up approach was employed for the Total Mesorectal Excision procedure', 'interventionNames': ['Procedure: transanal total mesorectal excision', 'Procedure: Laparoscopic Total Mesorectal Excision']}], 'interventions': [{'name': 'transanal total mesorectal excision', 'type': 'PROCEDURE', 'description': 'a transanal bottom-up approach was employed for the TME procedure', 'armGroupLabels': ['taTME']}, {'name': 'Laparoscopic Total Mesorectal Excision', 'type': 'PROCEDURE', 'description': 'Laparoscopic Total Mesorectal Excision', 'armGroupLabels': ['laTME', 'taTME']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yanhong Deng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Yanhong Deng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}