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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.
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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.
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50 participants in 2 patient groups
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Karl-Friedrich Kowalewski, M.D.
Data sourced from clinicaltrials.gov
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