ROBOCOP II (ROBOtic assisted versus conventional open partial nephrectomy) randomised, controlled feasibility trial:...

Area of Science:

• Urology
• Surgical Oncology
• Minimally Invasive Surgery

Background:

• Limited randomized controlled trials exist comparing robotic-assisted partial nephrectomy (RAPN) and open partial nephrectomy (OPN).
• There is a need to evaluate the feasibility and outcomes of RAPN versus OPN for renal neoplasms.

Purpose of the Study:

• To report the study protocol for a randomized controlled feasibility trial comparing RAPN and OPN.
• To assess the feasibility of recruitment for a trial comparing these two surgical approaches.
• To gather preliminary data on perioperative results, quality of life, and surgical ergonomics.

Main Methods:

• A single-center, randomized, open-label, feasibility trial design.
• Enrollment of 50 patients with renal neoplasms suitable for both RAPN and OPN.
• 1:1 allocation ratio with feasibility of recruitment as the primary endpoint (success if 1/3 eligible patients consent).

Main Results:

• The primary outcome is the feasibility of patient recruitment.
• Secondary endpoints include perioperative outcomes, health-related quality of life, inflammatory response, and surgical ergonomics.
• Results will inform the design of a future phase III trial if recruitment is feasible.

Conclusions:

• This feasibility trial is crucial for establishing the groundwork for a larger, confirmative phase III study.
• Successful recruitment will validate the comparison of RAPN and OPN in a randomized setting.
• The study aims to provide essential data for optimizing surgical management of renal neoplasms.