Clinical trial · Interventional
Study of NOTES-TME Versus L-LAR in Rectal Cancer
Multicenter Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Low Anterior Resection in Rectal Cancer
- 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)
INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach. MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results. METHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The sample calculation is 58 patients per group.
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-LAR | Procedure | — | UNRESOLVED |
| TRANSANAL TOTAL MESORECTAL EXCISION | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TRANSANAL TOTAL MESORECTAL EXCISION
- description
- Transanal approach of total mesorectal excision.
- interventionNames
- Procedure: TRANSANAL TOTAL MESORECTAL EXCISION
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic-LAR
- description
- Type of surgical intervention as control group: Laparoscopic low anterior resection with total mesorectal excision for rectal cancer
- interventionNames
- Procedure: Laparoscopic-LAR
Primary outcomes (4)
- measure
- Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 years * Patients with rectal cancer stage: cT1-2-3, cN0-1, cM0. * Tumor equal or below 10 cm from the anal verge, candidates to (ETM) low anterior resection and anastomosis, with or without preoperative chemo-radiotherapy. * Adenocarcinoma of low or moderate differentiation * ASA I, II, III. Exclusion Criteria: * Do not sign informed consent * Pregnant patients * Liver cirrhosis * Undifferentiated adenocarcinoma. * cT4 * Metastatic disease (M1) * chronic renal failure on dialysis * ASA IV * BMI \<18 and\> 35 kg / m2
References
Publications (5)
- BACKGROUNDSerra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27. PMID 25814073
- BACKGROUNDSerra-Aracil X. [Transanal total mesorectal excision]. Cir Esp. 2014 Apr;92(4):221-2. doi: 10.1016/j.ciresp.2014.01.002. Epub 2014 Feb 24. No abstract available. Spanish. PMID 24576748
- DERIVEDSerra-Aracil X, Gonzalez A, Bargallo J, Serracant A, Roura J, Cayetano-Paniagua L, Delgado S, Zarate A; Ta-LaTME Study Group. Quality of life, bowel dysfunction, and long-term oncological outcomes after transanal versus laparoscopic total mesorectal excision for mid- and low- rectal cancer (Ta-LaTME study): multicentre randomized open-label trial. BJS Open. 2026 Jul 3;10(4):zrag045. doi: 10.1093/bjsopen/zrag045. PMID 42551037
- DERIVEDSerra-Aracil X, Zarate A, Bargallo J, Gonzalez A, Serracant A, Roura J, Delgado S, Mora-Lopez L; Ta-LaTME study Group. Transanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial. Br J Surg. 2023 Jan 10;110(2):150-158. doi: 10.1093/bjs/znac324. PMID 36224406
- DERIVEDSerra-Aracil X, Zarate A, Mora L, Serra-Pla S, Pallisera A, Bonfill J, Bargallo J, Pando A, Delgado S, Balleteros E, Pericay C. Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer. Int J Colorectal Dis. 2018 May;33(5):649-655. doi: 10.1007/s00384-018-2996-8. Epub 2018 Mar 16. PMID 29546560