ELRR by TEM Versus Laparoscopic TME in iT2N0M0 SMALL LOW RECTAL CANCER
NCT01609504 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 283
Last updated 2012-06-01
Summary
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
Interventions
- PROCEDURE
-
ELRR BY TEM
The surgical technique of ELRR was 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
- PROCEDURE
-
LTME
LAPAROSCOPIC TOTAL MESORECTAL EXCISION INCLUDING MESORECTAL (ACCORDING TO HEALD CRITERIA)
Sponsors & Collaborators
-
Università Politecnica delle Marche
collaborator OTHER -
University of Roma La Sapienza
lead OTHER
Principal Investigators
-
Emanuele Lezoche, Pr · university Sapienza of Rome, Italy
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1997-04-30
- Primary Completion
- 2004-04-30
- Completion
- 2004-04-30
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