CompletedPhase 3

ELRR by TEM Versus Laparoscopic TME in iT2N0M0 SMALL LOW RECTAL CANCER

283 participantsStarted 1997-04

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT01609504

SponsorUniversity of Roma La Sapienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-04

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