Clinical trial · Interventional
Trans-anal Versus Laparoscopic TME for Mid and Low Rectal Cancer
(MansTaTME) Trans-anal Versus Laparoscopic Total Mesorectal Excision for Mid and Low Rectal Cancer
NCT03242187CI-TRIAL-00028969MansTaTMEunknownPhase 2 / Phase 3ClinicalTrials.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)
This study is designed to assess the surgical, oncological and functional outcome of either the laparoscopic or trans-anal TME in management of mid and low rectal cancer.
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 Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lap. TME | Procedure | — | UNRESOLVED |
| Trans-anal total mesorectal excision(TaTME) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trans-anal TME (TaTME)
- description
- Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)
- interventionNames
- Procedure: Trans-anal total mesorectal excision(TaTME)
- type
- ACTIVE_COMPARATOR
- label
- Lap. TME
- description
- Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection
- interventionNames
- Procedure: Lap. TME
Primary outcomes (3)
- measure
- Circumferential radial margin (CRM)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Anesthetically fit patient. 2. Non metastatic pathologically proven rectal cancer (Mid-Low). 3. Patients who received neoadjuvant chemo-radiotherapy will be included Exclusion Criteria: 1. Patients with American Society of Anesthesiologist (ASA) score 4 and 5. 2. Patients with cardiac or chest problems that cannot withstand CO2 insufflation. 3. Unresectable tumors (T4) (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation). 4. Obstructed or perforated cancer. 5. Patients with unresectable metastatic rectal cancer.
References
Publications (6)
- BACKGROUNDBrenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11. PMID 24225001
- BACKGROUNDVennix S, Pelzers L, Bouvy N, Beets GL, Pierie JP, Wiggers T, Breukink S. Laparoscopic versus open total mesorectal excision for rectal cancer. Cochrane Database Syst Rev. 2014 Apr 15;2014(4):CD005200. doi: 10.1002/14651858.CD005200.pub3. PMID 24737031
- BACKGROUNDQu C, Yuan RF, Huang J, Liu L, Jiang CH, Yang ZQ, Shao JH. [Meta-analysis of laparoscopic versus open total mesorectal excision for middle and low rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2013 Aug;16(8):748-52. Chinese. PMID 23980046
- BACKGROUNDDeijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4. PMID 26537907
- BACKGROUNDAtallah S, Martin-Perez B, Albert M, deBeche-Adams T, Nassif G, Hunter L, Larach S. Transanal minimally invasive surgery for total mesorectal excision (TAMIS-TME): results and experience with the first 20 patients undergoing curative-intent rectal cancer surgery at a single institution. Tech Coloproctol. 2014 May;18(5):473-80. doi: 10.1007/s10151-013-1095-7. Epub 2013 Nov 23. PMID 24272607
- BACKGROUNDSimillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151. PMID 26466751