Robotic-assisted vs. Open Partial Nephrectomy — ROBOCOP  

Renal Cell Carcinoma Clinical Trial

Official title: ROBOtic-assisted Versus Conventional Open Partial Nephrectomy: a Single-center, Open-label, Randomized Controlled Feasibility Trial

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

• 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