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A Trial to Assess Robot-assisted Surgery and Laparoscopy-assisted Surgery in Patients With Mid or Low Rectal Cancer

NCT01423214 · Kyungpook National University Hospital · Updated 11 March 2015

What is being tested
robot-assisted surgery; Laparoscopic surgery
For
Rectal Cancer
Kind of study
Tests a treatment or device on volunteers. Phase 3.
Who can join
Ages 18 years to 80 years. About 540 people. The full rules are on the registry page.
Where
South Korea (3 sites)
When
Starts or started June 2013, ends Dec 2018. Registered 25 Aug 2011.
Results
None posted yet.

In the researchers' words

This study sets up the final study end point and three detailed goals as the following. The main objective of study: This trial is done to assess the safety and benefit of robotic resection compared with conventional laparoscopy-assisted resection for curative treatment of patients with cancer of the mid or low rectum. Detailed goal of study: The primary endpoint: This study is designed to assess whether robotic surgical system improves the quality of rectal cancer surgery, especially in total mesorectal excision quality and a circumferential margin positivity rate The secondary endpoint: This study aims to compare 3- and 5-year disease-free survival and overall survival after robot and laparoscopic resection of distal rectal cancer. This study will also assess the pelvic autonomic nerve preservation, short-term morbidity, pathological quality (i.e. number of harvested lymph node), local recurrence, and blood loss during surgery.
ClinicalTrials.gov, NCT01423214

Sites

  • Gyu seog ChoiDaegu, South Korea
  • Nam Kyu KimSeoul, South Korea
  • Seon-Hahn KimSeoul, South Korea