Robotic-assisted vs. Open Partial Nephrectomy (ROBOCOP)

U

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)

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

Trial contacts and locations

1

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Central trial contact

Karl-Friedrich Kowalewski, M.D.

Data sourced from clinicaltrials.gov

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