Clinical trial · Interventional
ELRR by TEM Versus Laparoscopic TME in iT2N0M0 SMALL LOW RECTAL CANCER
Randomized Controlled Clinical Trial: Endoluminal Loco-regional Resection (ELRR) by Transanal Endoscopic Microsurgery (TEM) Versus Laparoscopic Total Mesorectal Excision (LTME) in it2n0m0 Small Low Rectal Cancer
NCT01609504CI-TRIAL-00007031ELRRvsLTMEcompletedPhase 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)
The present prospective randomized study investigated the results of ELRR (ENDOLUMINAL LOCO-REGIONAL RESECTION BY TRANSANAL ENDOSCOPIC MICROSURGERY) versus LTME (LAPAROSCOPIC TOTAL MESORECTAL EXCISION) in the management of 100 patients with iT2N0M0 small low rectal cancer after Neoadjuvant Treatment.
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 |
|---|---|---|---|
| ELRR BY TEM | Procedure | — | UNRESOLVED |
| LTME | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transanal Endoscopic Microsurgery
- description
- Patients were treated by TEM as follows: mucosal incision included all the tatoo spots performed at admission staging, in order to excise a minimum of 1 cm of normal mucosa around the tumor, according to its diameter before NT (ELRR- Endo Luminal Loco Regional Resection)
- interventionNames
- Procedure: ELRR BY TEM
- type
- ACTIVE_COMPARATOR
- label
- Total Mesorectal Excision
- interventionNames
- Procedure: LTME
Primary outcomes (1)
- measure
- oncological result in term of local and/or systematic recurrence
- timeFrame
- 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Tumor located within 6 cm from the anal verge * Tumor diameter not larger than 3 cm, and staged as iT2, N0, G1-2 Exclusion Criteria: * Patients classified as American Society of Anaesthesiologists (ASA) 3 or 4
References
Publications (2)
- DERIVEDMotamedi MAK, Mak NT, Brown CJ, Raval MJ, Karimuddin AA, Giustini D, Phang PT. Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy. Cochrane Database Syst Rev. 2023 Jun 13;6(6):CD002198. doi: 10.1002/14651858.CD002198.pub3. PMID 37310167
- DERIVEDLezoche E, Baldarelli M, Lezoche G, Paganini AM, Gesuita R, Guerrieri M. Randomized clinical trial of endoluminal locoregional resection versus laparoscopic total mesorectal excision for T2 rectal cancer after neoadjuvant therapy. Br J Surg. 2012 Sep;99(9):1211-8. doi: 10.1002/bjs.8821. PMID 22864880