Status not kept up to date
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.
Sites
- Gyu seog ChoiDaegu, South Korea
- Nam Kyu KimSeoul, South Korea
- Seon-Hahn KimSeoul, South Korea
