NCT03849820

Open vs Robotic Assisted Partial Nephrectomy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate that Robotic-Assisted partial nephrectomy is superior to Open partial nephrectomy in reducing the number of 30 day post-operative complications (Clavien-Dindo Type I-V) for patients with intermediate to high complexity kidney tumors.

Detailed description

Partial nephrectomy is the surgical removal of a kidney tumor while unaffected tissue remains intact so that the kidney function is maintained as far as possible. The more radical procedure would be the complete removal of the kidney, which is not examined in this trial. Surgery will be randomized either to an open technique involving a large incision or the robotic assisted technique with a few small incisions (keyhole surgery). With robotic assisted surgery the movements of the surgeon are translated into the movement of the instruments. It is not clear which of the two procedures, open or robotic assisted, has less complications. It is expected that these are different due to the different level of invasiveness and the level of direct access to the organ. This study aims to show that robotic assisted surgery results in less complications than open surgery.

Conditions

• Renal Cancer

Interventions

Type	Name	Description
DEVICE	Robotic-assisted partial nephrectomy	Application of the da Vinci surgical robot to assist the partial nephrectomy
OTHER	Open partial nephrectomy	Open surgery to conduct the partial nephrectomy

Timeline

• Start date: 2019-03-12
• Primary completion: 2021-12-15
• Completion: 2022-10-25
• First posted: 2019-02-21
• Last updated: 2025-06-17

Locations

12 sites across 1 country: Germany

Regulatory

• FDA-regulated device study