Robotic Assisted Transanal Total Mesorectal Excision Surgery for Rectal Cancer in Low Site
NCT ID: NCT03422835
Last Updated: 2018-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2018-02-15
2023-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Robotic vs. TaTME Rectal Surgery (ROTA STUDY)
NCT04200027
The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer
NCT01125111
Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer
NCT02673177
Study on Effect of Robotic Versus Laparoscopic Surgical Technology on Genitourinary Function After Total Mesorectal Excision for Rectal Cancer
NCT06409403
Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation
NCT06814093
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
R-TME
Robotic total mesentery excision surgery for rectal cancer.
R-TME
Conventional Robotic Total Mesentery Excision
R-TaTME
Robotic transanal total mesentery excision surgery for rectal cancer.
R-TaTME
Robotic Transanal Total Mesentery Excision
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
R-TME
Conventional Robotic Total Mesentery Excision
R-TaTME
Robotic Transanal Total Mesentery Excision
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* the lower edge of the tumor from the anal margin less than 8cm according to MRI or rigid endoscopy
* tumor diameter less than 4cm
* baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
* tolerable to surgery
* be able to understand and willing to participate in this trial with signature
Exclusion Criteria
* recent diagnosis with other malignancies
* patients requiring emergency surgery such as obstruction，perforation and bleeding
* tumor involving adjacent organs, anal sphincter, or levator ani muscle muti-focal colorectal cancer
* preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence history of inflammatory bowel disease or familial adenomatous polyposis
* participating in other clinical trails
* History of pelvic radiation
* BMI \> 40
* Large uterine fibroids
* can not tolerate the surgery
* history of serious mental illness
* pregnancy or lactating women
* preoperative uncontrolled infection
* the researchers believe the patients should not enrolled in
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
fan li
Prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
fan li, MD.
Role: PRINCIPAL_INVESTIGATOR
Daping Hospital, Third Military Medical University
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RATERAL-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.