NCT04534998

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

August 16, 2020

Last Update Submit

September 2, 2021

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Recruitment rate

    Proportion of randomized patients in relation to the eligible ones.

    15 months

Secondary Outcomes (25)

  • Perioperative complications

    throughout patient´s hospital stay, on average 6 days

  • Postoperative complications

    90 days

  • Self-reported generic health status

    90 days

  • Self-reported quality of life assessment of cancer patients

    90 days

  • Self-reported quality of life in patients with kidney disease

    90 days

  • +20 more secondary outcomes

Study Arms (2)

Robotic-assisted partial nephrectomy

EXPERIMENTAL

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

Procedure: Partial nephrectomy

Open partial nephrectomy

ACTIVE COMPARATOR

Partial nephrectomy will be performed using an open retroperitoneal approach.

Procedure: Partial nephrectomy

Interventions

Partial nephrectomyPROCEDURE

Partial nephrectomy for localized kidney cancer as curative treatment.

Also known as: nephron-sparing surgery
Open partial nephrectomyRobotic-assisted partial nephrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients with solitary kidney
  • multiple kidney tumors
  • emergency intervention, for example because of bleeding or perforation
  • nd 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, University Medical Center Mannheim, University of Heidelberg

Mannheim, Baden-Wurttemberg, 68167, Germany

RECRUITING

Related Publications (1)

  • Kowalewski KF, Sidoti Abate MA, Neuberger M, Kirchner M, Krisam R, Egen L, Haney CM, Siegel F, Michel MS, Honeck P, Nuhn P, Westhoff N, Kriegmair MC. ROBOCOP II (ROBOtic assisted versus conventional open partial nephrectomy) randomised, controlled feasibility trial: clinical trial protocol. BMJ Open. 2021 Nov 3;11(11):e052087. doi: 10.1136/bmjopen-2021-052087.

    PMID: 34732486DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Maximilian C. Kriegmair, M.D.

    Department of Urology, University Medical Center Mannheim, University of Heidelberg

    STUDY DIRECTOR

Central Study Contacts

Karl-Friedrich Kowalewski, M.D.

CONTACT

00496213832201karl-friedrich.kowalewski@umm.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2020

First Posted

September 1, 2020

Study Start

June 15, 2020

Primary Completion

December 15, 2021

Study Completion

March 15, 2022

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Patient information might be shared after signing a data sharing agreement and IRB approval

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
After completion of the study (anticipated March 2021)

Locations

DE(1)