Clinical trial · Interventional
Robotic Assisted Transanal Total Mesorectal Excision Surgery for Rectal Cancer in Low Site
A Prospective Cohort Study of Robotic Transanal Total Mesentery Excision Versus Conventional Robotic Surgery for Rectal Cancer in Low Site
NCT03422835CI-TRIAL-00031551unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-TaTME | Procedure | — | UNRESOLVED |
| R-TME | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
- measure
- Positive rate of circumferential resection margin (CRM) of the specimens
- timeFrame
- 10 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * adenocarcinoma of the rectum by biopsy * 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: * history of malignant colorectal neoplasia * 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
References
Publications (8)
- BACKGROUNDHeald 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 6751457
- BACKGROUNDKim 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 28549014
- BACKGROUNDKuo 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 27744632
- BACKGROUNDWang 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 26620555
- BACKGROUNDOdermatt 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 26342816
- BACKGROUNDZhang 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 22936590
- BACKGROUNDde 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.