Clinical trial · Interventional
Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer.
Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer. A Multicentre Randomised Clinical Trial on Anastomotic Leak
NCT03413904CI-TRIAL-00034247taTMEunknownN/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)
This study is designed as a prospective, multi-center, randomized, open-labelled, parallel group, non-inferiority trial. The aim of this study is to evaluate the TaTME technique compared with conventional laparoscopic rectal surgery, focusing on, anastomotic dehiscence, conversion rate to open surgery, hospital stay and long-term functional outcomes.
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 |
|---|---|---|---|
| laparoscopic TME | Procedure | — | UNRESOLVED |
| transanal TME | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- transanal TME
- description
- Study procedure will consist in 2-team (combined) LAR with transanal TME using laparoscopic abdominal assistance.Transanal TME is performed either at the same time or following the above steps. Transanal endoscopic TME dissection will proceed circumferentially until the peritoneal cavity is entered anteriorly. Following complete mobilization of the rectosigmoid, the specimen is extracted transanally or using a Pfannenstiel incision followed by colorectal anastomosis, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
- interventionNames
- Procedure: transanal TME
- type
- ACTIVE_COMPARATOR
- label
- laparoscopic TME
- description
- Procedure will consist in 1 team performing laparoscopic TME. Following stapled closure of the rectum below the tumor, and complete mobilization of the rectosigmoid, the specimen is extracted using a Pfannenstiel incision . A stapled (knight-Griffen) colorectal anastomosis or coloanal anastomosis will be created and a temporary diverting stoma will be fashioned which is standard of care following surgery for this type of cancer.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven solitary mid and low rectal cancer * proven by rigid rectoscopy, pelvic MRI and digital rectal examination (DRE) * amenable to curative sphincter-preserving surgery * no evidence of distant metastases (T3-4a,N0 or T1-4a,N1-2) * if evaluated after neoadiuvant therapy, no evidence of threaten of the mesorectal fascia (MRF) after therapy Exclusion Criteria: * no indication to perform sphincter preservation surgery (Tumors invading into the internal anal sphincter muscle based on pelvic MRI) * T4b tumor invading adjacent organs * recurrent cancer * concurrent or previous diagnosis of invasive cancer within 5 years * prior history of colorectal resection * tumors with in growth more than 1/3 of anal sphincter complex or levator ani. * presence of fecal incontinence at baseline according to Wexner's classification * emergent surgery with intestinal obstruction or perforation * absolute contraindications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease (ASA class \> III)
References
Publications (20)
- BACKGROUNDKang J, Choi GS, Oh JH, Kim NK, Park JS, Kim MJ, Lee KY, Baik SH. Multicenter Analysis of Long-Term Oncologic Impact of Anastomotic Leakage After Laparoscopic Total Mesorectal Excision: The Korean Laparoscopic Colorectal Surgery Study Group. Medicine (Baltimore). 2015 Jul;94(29):e1202. doi: 10.1097/MD.0000000000001202. PMID 26200636
- BACKGROUNDLeroy J, Jamali F, Forbes L, Smith M, Rubino F, Mutter D, Marescaux J. Laparoscopic total mesorectal excision (TME) for rectal cancer surgery: long-term outcomes. Surg Endosc. 2004 Feb;18(2):281-9. doi: 10.1007/s00464-002-8877-8. Epub 2003 Dec 29. PMID 14691716
- BACKGROUNDMorino M, Parini U, Giraudo G, Salval M, Brachet Contul R, Garrone C. Laparoscopic total mesorectal excision: a consecutive series of 100 patients. Ann Surg. 2003 Mar;237(3):335-42. doi: 10.1097/01.SLA.0000055270.48242.D2. PMID 12616116
- BACKGROUNDGoldberg S, Klas JV. Total mesorectal excision in the treatment of rectal cancer: a view from the USA. Semin Surg Oncol. 1998 Sep;15(2):87-90. doi: 10.1002/(sici)1098-2388(199809)15:23.0.co;2-1. PMID 9730414
- BACKGROUNDKapiteijn E, Kranenbarg EK, Steup WH, Taat CW, Rutten HJ, Wiggers T, van Krieken JH, Hermans J, Leer JW, van de Velde CJ. Total mesorectal excision (TME) with or without preoperative radiotherapy in the treatment of primary rectal cancer. Prospective randomised trial with standard operative and histopathological techniques. Dutch ColoRectal Cancer Group. Eur J Surg. 1999 May;165(5):410-20. doi: 10.1080/110241599750006613. PMID 10391155
- BACKGROUNDMarks JH, Myers EA, Zeger EL, Denittis AS, Gummadi M, Marks GJ. Long-term outcomes by a transanal approach to total mesorectal excision for rectal cancer. Surg Endosc. 2017 Dec;31(12):5248-5257. doi: 10.1007/s00464-017-5597-7. Epub 2017 Jun 22. PMID 28643051
- Arroyave MC, DeLacy FB, Lacy AM. Transanal total mesorectal excision (TaTME) for rectal cancer: Step by step description of the surgical technique for a two-teams approach. Eur J Surg Oncol. 2017 Feb;43(2):502-505. doi: 10.1016/j.ejso.2016.10.024. Epub 2016 Nov 20.