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Clinical Trial Summary

ROBOCOP is an open-label, randomized controlled feasibility trial comparing robotic-assisted and open partial nephrectomy in preparation for a confirmative phase III randomized controlled trial.


Clinical Trial Description

Surgical excision is the gold standard for the treatment for localized kidney cancer. An organ-preserving procedure should be carried out whenever possible in order to maintain kidney function. Partial nephrectomy can be performed through the conventional open technique as well as through a robotic-assisted approach. Although both methods belong to the standard care, there is still no published data from randomized controlled trials in the scientific literature comparing them. The ROBOCOP-trial is designed as a single-center comparison of the two surgical approaches in preparation for a phase III study. 50 patients are to be included in the trial within a period of 15 months. The primary endpoint is feasibility of patient recruitment. In addition, potential primary outcomes for a confirmative trial such as perioperative complications, quality of life, inflammatory response, survival and ergonomic aspects for the operating surgeons will be investigated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04534998
Study type Interventional
Source Universitätsmedizin Mannheim
Contact Karl-Friedrich Kowalewski, M.D.
Phone 00496213832201
Email karl-friedrich.kowalewski@umm.de
Status Recruiting
Phase Phase 2
Start date June 15, 2020
Completion date March 15, 2022

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