Robotic-assisted vs. Open Partial Nephrectomy (ROBOCOP)

Universitätsmedizin Mannheim

Status and phase: Unknown; Phase 2

Conditions: Renal Cell Carcinoma

Treatments: Procedure: Partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04534998

2020-542N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled for elective partial nephrectomy for renal neoplasms
• Patient must be at least 18 years old and capable to consent
• abdominal MRI or CT scan
• curative-intent surgery
• robotic-assisted and open approach for surgery are both feasible
• ability of patient to understand the goal, consequences and alternatives of participation in the trial
• written informed consent

Exclusion criteria

• patients with solitary kidney
• multiple kidney tumors
• emergency intervention, for example because of bleeding or perforation
• 2nd malignancy that will make PN needless, this does not include secondary malignancies which are under curative treatment or cases in which death from RCC is more likely
• patient belongs to a vulnerable patient group
• simultaneous 2nd surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Robotic-assisted partial nephrectomy

Experimental group

Description:

Partial nephrectomy will be performed using a robotic-assisted laparoscopic approach.

Treatment:

Procedure: Partial nephrectomy

Open partial nephrectomy

Active Comparator group

Description:

Partial nephrectomy will be performed using an open retroperitoneal approach.

Treatment:

Procedure: Partial nephrectomy