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Not recruiting yet

Robotic vs. TaTME Rectal Surgery (ROTA STUDY)

NCT04200027 · Odense University Hospital · Updated 3 Aug 2021

What is being tested
total mesorectal excision
For
Rectal Cancer
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 330 people. The full rules are on the registry page.
Where
Denmark, United Kingdom (2 sites)
When
Starts or started 15 Nov 2021, ends 1 Nov 2026. Registered 16 Dec 2019.
Results
None posted yet.

In the researchers' words

Background Recent novel surgical techniques for resection of low rectal cancer have been introduced and these approaches have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME). Both approaches have distinct advantages and limitations however there have been no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experienced surgeons. Previous studies looking at the oncological outcomes of either TaTME or robotic TME included many centres where the surgeons were on a learning curve and hence the true oncological outcomes and clinical benefits cannot be measured accurately. The primary objective of this pilot study is to conduct a multicentre prospective trial to investigate clinical outcomes, in particular disease free survival (DFS) in patients undergoing RLAR and TaTME. The additional goal is to investigate other efficacy measures, complications rates, recruitment feasibility and protocol refinement. Method This pilot study will be a prospective, observational, case-matched, two -cohort, multicentre designed to investigate the oncological and clinical outcomes of patients with mid-to-low, non-metastatic rectal cancer undergoing low anterior…
ClinicalTrials.gov, NCT04200027

Sites

  • Issam al-NajamiSvendborg, Southern Denmark, Denmark
  • Jim KhanPortsmouth, United Kingdom