Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-01 @ 10:02 AM
Study NCT ID:
NCT02252250
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2014-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2020-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2014-09-29', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'defecating functional outcomes', 'timeFrame': '1-6 years', 'description': 'constipation score and incontinence score'}, {'measure': 'sexual functional outcomes', 'timeFrame': '1-6 years', 'description': 'We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (International Index of Erectile Function (IIEF)'}, {'measure': 'Quality of life outcomes evaluation', 'timeFrame': '1-6 years', 'description': 'We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36) and Gastro-Intestinal Functional Outcome(GIFO)) .'}], 'primaryOutcomes': [{'measure': 'Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.', 'timeFrame': '1-6 years', 'description': 'Lymph nodes number; rate of positive circumferential resection margin(CRM);'}], 'secondaryOutcomes': [{'measure': 'Incidence of 30-day perioperative complications including intraoperative, and postoperative complications', 'timeFrame': '0-30 days', 'description': 'bleeding, injury of adjacent organs, ileus, leakage, infection'}, {'measure': 'Incidence of long-term complications', 'timeFrame': '1-6 years', 'description': 'incision hernia,'}, {'measure': 'Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.', 'timeFrame': '1-6 years', 'description': 'overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rectal cancer', 'laparoscopic', 'taTME', 'TME'], 'conditions': ['Rectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.', 'detailedDescription': 'Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show that such NOTES procedures are feasible and safe. And also, lots of experimental studies and small case series reporting the feasibility of transanal anterior resection with single incision laparoscopic surgery(SILS) port or other devices. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function, sexual function, QOF) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive total mesentery excision for rectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy-proven adenocarcinoma of the rectum\n* Eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma\n* Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI\n* Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI\n* Rectal cancer located 3-10 cm from the anal verge\n\nExclusion Criteria:\n\n* Metastasis\n* Obstructing rectal cancer\n* Synchronous colon cancer\n* T4 rectal cancer not treated preoperatively with full-course chemoradiation\n* Pregnant or breast-feeding\n* Receiving any other study agents\n* Fecal incontinence\n* History of prior colorectal cancer\n* History of inflammatory bowel disease\n* History of pelvic radiation\n* BMI \\> 40\n* Large uterine fibroids\n* Uncontrolled intercurrent illness'}, 'identificationModule': {'nctId': 'NCT02252250', 'briefTitle': 'Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer', 'orgStudyIdInfo': {'id': '20141056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional laparoscopic', 'description': 'conventional laparoscopic total mesentery excision surgery for rectal cancer.', 'interventionNames': ['Procedure: conventional laparoscopic total mesentery excision']}, {'type': 'EXPERIMENTAL', 'label': 'Transanal hybrid-laparoscopic', 'description': 'Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer.', 'interventionNames': ['Procedure: transanal hybrid-laparoscopic total mesentery excision']}], 'interventions': [{'name': 'conventional laparoscopic total mesentery excision', 'type': 'PROCEDURE', 'otherNames': ['LTME'], 'description': 'conventional laparoscopic total mesentery excision', 'armGroupLabels': ['conventional laparoscopic']}, {'name': 'transanal hybrid-laparoscopic total mesentery excision', 'type': 'PROCEDURE', 'otherNames': ['TLTME'], 'description': 'transanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA.', 'armGroupLabels': ['Transanal hybrid-laparoscopic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Daping hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Weidong Tong, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daping Hospital, Third Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Weidong Tong', 'investigatorAffiliation': 'Third Military Medical University'}}}}