Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT03422835
Status:
UNKNOWN
Last Update Posted:
2018-02-06
First Post:
2018-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Robotic Assisted Transanal Total Mesorectal Excision Surgery for Rectal Cancer in Low Site
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-30', 'studyFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2018-01-30', 'lastUpdatePostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'defecating functional outcomes', 'timeFrame': '3 years after surgery', 'description': 'Wexner scale'}, {'measure': 'sexual functional outcomes', 'timeFrame': '2 years after surgery', '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': '2 years rafter surgery', 'description': 'We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36).'}], 'primaryOutcomes': [{'measure': 'Positive rate of circumferential resection margin (CRM) of the specimens', 'timeFrame': '10 days after surgery', 'description': 'Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while \\>1mm is negative.'}], 'secondaryOutcomes': [{'measure': 'The grade score of the specimens integrity', 'timeFrame': '10 days after surgery', 'description': 'the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see \\>5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.'}, {'measure': 'The distance between lower tumor margin and the lower reaction margin', 'timeFrame': '10 days after surgery', 'description': 'the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.'}, {'measure': 'postoperative hospital stay', 'timeFrame': '3 years after surgery', 'description': 'recovery information.'}, {'measure': 'disease free survival rate', 'timeFrame': '3 years after surgery', 'description': 'the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.'}, {'measure': 'overall survival rate', 'timeFrame': '3 years after surgery', 'description': 'the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.'}, {'measure': 'the rate of postoperative complications', 'timeFrame': '30 days after surgery', 'description': 'preoperative safety containing operation information, complication information.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transanal surgery', 'robotic surgery', 'total mesorectal excision'], 'conditions': ['Rectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '6751457', 'type': 'BACKGROUND', 'citation': 'Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.'}, {'pmid': '28549014', 'type': 'BACKGROUND', 'citation': 'Kim MJ, Park SC, Park JW, Chang HJ, Kim DY, Nam BH, Sohn DK, Oh JH. Robot-assisted Versus Laparoscopic Surgery for Rectal Cancer: A Phase II Open Label Prospective Randomized Controlled Trial. Ann Surg. 2018 Feb;267(2):243-251. doi: 10.1097/SLA.0000000000002321.'}, {'pmid': '27744632', 'type': 'BACKGROUND', 'citation': 'Kuo LJ, Ngu JC, Tong YS, Chen CC. Combined robotic transanal total mesorectal excision (R-taTME) and single-site plus one-port (R-SSPO) technique for ultra-low rectal surgery-initial experience with a new operation approach. Int J Colorectal Dis. 2017 Feb;32(2):249-254. doi: 10.1007/s00384-016-2686-3. Epub 2016 Oct 15.'}, {'pmid': '26620555', 'type': 'BACKGROUND', 'citation': 'Wang Y, Liu R, Zhang Z, Xue Q, Yan J, Yu J, Liu H, Zhao L, Mou T, Deng H, Li G. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial. Trials. 2015 Nov 30;16:539. doi: 10.1186/s13063-015-1067-5.'}, {'pmid': '26342816', 'type': 'BACKGROUND', 'citation': 'Odermatt M, Flashman K, Khan J, Parvaiz A. Laparoscopic-assisted abdominoperineal resection for low rectal cancer provides a shorter length of hospital stay while not affecting the recurrence or survival: a propensity score-matched analysis. Surg Today. 2016 Jul;46(7):798-806. doi: 10.1007/s00595-015-1244-x. Epub 2015 Sep 5.'}, {'pmid': '22936590', 'type': 'BACKGROUND', 'citation': 'Zhang H, Zhang YS, Jin XW, Li MZ, Fan JS, Yang ZH. Transanal single-port laparoscopic total mesorectal excision in the treatment of rectal cancer. Tech Coloproctol. 2013 Feb;17(1):117-23. doi: 10.1007/s10151-012-0882-x. Epub 2012 Aug 31.'}, {'pmid': '23519489', 'type': 'BACKGROUND', 'citation': 'de Lacy AM, Rattner DW, Adelsdorfer C, Tasende MM, Fernandez M, Delgado S, Sylla P, Martinez-Palli G. Transanal natural orifice transluminal endoscopic surgery (NOTES) rectal resection: "down-to-up" total mesorectal excision (TME)--short-term outcomes in the first 20 cases. Surg Endosc. 2013 Sep;27(9):3165-72. doi: 10.1007/s00464-013-2872-0. Epub 2013 Mar 22.'}, {'pmid': '25185463', 'type': 'BACKGROUND', 'citation': 'Fernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865.'}]}, 'descriptionModule': {'briefSummary': 'To investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.', 'detailedDescription': 'Transanal total mesorectal excision (TaTME) may offer a better way to achieve radical resection and functional protection for lower rectal cancer, which have been regarded as challenging situations in rectal cancer surgery. However, the narrow angle and limited space of the operation restrict the wide spread of this technique. Da Vinci robotic system has achieved good results in rectal cancer surgery. Robotics may help to overcome technical difficulties in TaTME. The purpose of this study was to explore the availability of Da Vinci robotic-assisted transanal total mesorectal excision(R-TaTME) This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adenocarcinoma of the rectum by biopsy\n* the lower edge of the tumor from the anal margin less than 8cm according to MRI or rigid endoscopy\n* tumor diameter less than 4cm\n* baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)\n* tolerable to surgery\n* be able to understand and willing to participate in this trial with signature\n\nExclusion Criteria:\n\n* history of malignant colorectal neoplasia\n* recent diagnosis with other malignancies\n* patients requiring emergency surgery such as obstruction，perforation and bleeding\n* tumor involving adjacent organs, anal sphincter, or levator ani muscle muti-focal colorectal cancer\n* preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence history of inflammatory bowel disease or familial adenomatous polyposis\n* participating in other clinical trails\n* History of pelvic radiation\n* BMI \\> 40\n* Large uterine fibroids\n* can not tolerate the surgery\n* history of serious mental illness\n* pregnancy or lactating women\n* preoperative uncontrolled infection\n* the researchers believe the patients should not enrolled in'}, 'identificationModule': {'nctId': 'NCT03422835', 'briefTitle': 'Robotic Assisted Transanal Total Mesorectal Excision Surgery for Rectal Cancer in Low Site', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'A Prospective Cohort Study of Robotic Transanal Total Mesentery Excision Versus Conventional Robotic Surgery for Rectal Cancer in Low Site', 'orgStudyIdInfo': {'id': 'RATERAL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'R-TME', 'description': 'Robotic total mesentery excision surgery for rectal cancer.', 'interventionNames': ['Procedure: R-TME']}, {'type': 'EXPERIMENTAL', 'label': 'R-TaTME', 'description': 'Robotic transanal total mesentery excision surgery for rectal cancer.', 'interventionNames': ['Procedure: R-TaTME']}], 'interventions': [{'name': 'R-TME', 'type': 'PROCEDURE', 'description': 'Conventional Robotic Total Mesentery Excision', 'armGroupLabels': ['R-TME']}, {'name': 'R-TaTME', 'type': 'PROCEDURE', 'description': 'Robotic Transanal Total Mesentery Excision', 'armGroupLabels': ['R-TaTME']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'fan li, MD.', 'role': 'CONTACT', 'email': 'levinecq@163.com', 'phone': '+86 023 68757958'}], 'overallOfficials': [{'name': 'fan li, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daping Hospital, Third Military Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'fan li', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}