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CME Versus Standard Right Hemicolectomy for Right Sided Cancers

NCT05230329 · Odense University Hospital · Updated 8 Feb 2022

What is being tested
right sided hemicolectomy, laparoscopy
For
Colon 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
When
Starts or started 1 March 2022, ends 1 Feb 2028. Registered 8 Feb 2022.
Results
None posted yet.

In the researchers' words

Our aim of this study is to compare the difference in lymph node yield in CME specimens versus those patients having a standard right hemicolectomy for right sided cancer .The secondary aim of this study was to investigate whether there is an interaction between greater lymph node harvest towards increased survival. Another subgroup analysis of this study is to compare the complications and oncological outcome between laparoscopic versus Robotic CME. Trial Title CME versus standard right hemicolectomy for right sided cancers Internal ref. no. Clinical Phase Trial Design Observational, prospective, international, multi-center study Trial sites 10 sites over 5 different countries Planned Sample Size At least 330 subjects will be enrolled in this study per cohort, including 10% of lost to follow-up patients). All patients during the enrolment period shall be screened and recorded at sites in order to identify any selection bias Treatment duration 3 years Follow up duration 5 years Planned Trial Period 10 years Objectives Outcome Measures Primary To compare the lymph node yield between complete mesocolic excision versus standard right hemicolectomy for patients with right sided cancer Number of harvested lymph nodes Secondary Incidence of local recurrence after surgery at 2 and 5 years Disease free survival (2 and 5 years) 5-year overall survival 30-day and 90-day mortality,…
ClinicalTrials.gov, NCT05230329

Sites

  • Issam al-NajamiSvendborg, Southern Denmark, Denmark