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Pathology Assessment of Mesorectal Fascia After TME by Laparoscopic, Open, TransAnal and Robotic Approaches (LOTARTME)

NCT04949672 · San Giovanni Addolorata Hospital · Updated 2 July 2021

What is being tested
Not stated
For
Rectal Cancer; Surgery
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages Not stated. About 153 people. The full rules are on the registry page.
Where
Italy
When
Starts or started Jan 2017, ends 29 June 2021. Registered 2 July 2021.
Results
None posted yet.

In the researchers' words

TME is the gold standard surgical treatment of rectal cancer. Specimen quality, integrity of mesorectal fascia and lymph nodes harvest are expression of radicality and good surgery. The LOTARTME study is designed to assess which of the open, laparoscopic, robotic and endoscopic transanal approach is superior. Primary outcome is the evaluation of completeness of mesorectal fascia according to Quirke classification. Secondary outcomes are lymph nodes harvest, local recurrences, overall survivals, cancer related survivals. Inclusion criteria: any patient of any age and sex undergoing to intent-to-treat surgery operated by experienced surgeon. Exclusion criteria: patients with rectal cancer undergoing palliative surgery or multivisceral resection; all patients operated by less experienced surgeons. Study period January 1, 2017 - June 30 2021 and patients enrollment: January 1, 2017 - December 31, 2020. Data collection and analysis: data are collected in a prospective database and statical analysis is carried out using AnalystSoft StatPlus for Windows Software.
ClinicalTrials.gov, NCT04949672

Sites

  • San Giovanni Addolorata Hospital ComplexRoma, RM, Italy