Clinical trial · Interventional
Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer
NCT04573738CI-TRIAL-00071727completedN/AClinicalTrials.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)
Total mesorectal excision has greatly reduced the local recurrence rate of rectal cancer after colorectal surgery. Transanal total mesorectal excision(TaTME) is potentially a suitable option for patients with middle and low rectal cancer. Robotic systems are expected to develop the advantages of TaTME to overcome the limitations of laparoscopic surgery. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Perioperative Complication | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic assisted transanal total mesorectal excision | Procedure | — | UNRESOLVED |
| Robotic assisted transanal total mesorectal excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic transanal surgery
- description
- Robotic assisted transanal total mesorectal excision for rectal cancer patients
- interventionNames
- Procedure: Robotic assisted transanal total mesorectal excision
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic transanal surgery
- description
- Laparoscopic transanal total mesorectal excision for rectal cancer patients
- interventionNames
- Procedure: Laparoscopic assisted transanal total mesorectal excision
Primary outcomes (4)
- measure
- The local recurrence rates of rectal cancer
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathological biopsy confirmed adenocarcinoma of the rectum. 2. Preoperative assessment of tolerance to surgery without major organ dysfunction. 3. Patients must be able to understand and voluntarily sign written informed consent. 4. The surgical method is robotic assisted transanal total mesorectal excision 5. Distance of the edge of the tumour within 8 cm Exclusion Criteria: 1. The patient cannot tolerate the operation. 2. Refusal to sign informed consent. 3. Patients with distant metastasis of rectal cancer. 4. The surgical method was changed to miles or Hartman; 5. Unable to complete the follow - up
References
Publications (4)
- BACKGROUNDLee L, de Lacy B, Gomez Ruiz M, Liberman AS, Albert MR, Monson JRT, Lacy A, Kim SH, Atallah SB. A Multicenter Matched Comparison of Transanal and Robotic Total Mesorectal Excision for Mid and Low-rectal Adenocarcinoma. Ann Surg. 2019 Dec;270(6):1110-1116. doi: 10.1097/SLA.0000000000002862. PMID 29916871
- BACKGROUNDJayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219. PMID 29067426
- BACKGROUNDAtallah S, Martin-Perez B, Pinan J, Quinteros F, Schoonyoung H, Albert M, Larach S. Robotic transanal total mesorectal excision: a pilot study. Tech Coloproctol. 2014 Nov;18(11):1047-53. doi: 10.1007/s10151-014-1181-5. Epub 2014 Jun 24. PMID 24957360
- BACKGROUNDYe J, Tian Y, Wang L, Ye Y, Zhang Y, Li F, Liu B, Tong W. [Robotic-assisted transanal total mesorectal excision for lower rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Aug 25;20(8):900-903. Chinese. PMID 28836251