Clinical trial NCT04534998: Robotic-assisted vs. Open Partial Nephrectomy
Official title: ROBOtic-assisted Versus Conventional Open Partial Nephrectomy: a Single-center, Open-label, Randomized Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
Collaborators: name: Institute of Medical Biometry and Informatics, University of Heidelberg
name: Dietmar Hopp Stiftung
First posted: 2020-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 15 months
Secondary outcomes:
measure: Perioperative complications
timeFrame: throughout patient´s hospital stay, on average 6 days
measure: Postoperative complications
timeFrame: 90 days
measure: Self-reported generic health status
timeFrame: 90 days
measure: Self-reported quality of life assessment of cancer patients
timeFrame: 90 days
measure: Self-reported quality of life in patients with kidney disease
timeFrame: 90 days
measure: Self-assessment of depression in patients ≥ 65 years old
timeFrame: 90 days
measure: Self-evaluation of cancer disease´s influence on elderly patients´ life
timeFrame: 90 days
measure: Self-assessment of comorbidity in elderly patients
timeFrame: 90 days
measure: Postoperative self-reported quality of life
timeFrame: 90 days
measure: Kidney function - creatinine
timeFrame: 90 days
measure: Kidney function - GFR
timeFrame: 90 days
measure: Length of hospital stay
timeFrame: throughout patient´s hospital stay, on average 6 days
measure: Operative time
timeFrame: Immediately after surgery
measure: Inflammatory response - leucocytes
timeFrame: throughout patient´s hospital stay, on average 6 days
measure: Inflammatory response - C-reactive protein
timeFrame: throughout patient´s hospital stay, on average 6 days
measure: Inflammatory response
timeFrame: throughout patient´s hospital stay, on average 6 days
measure: Surgical ergonomics
timeFrame: Immediately after surgery
measure: Surgical ergonomics
timeFrame: During surgery
measure: Resection status
timeFrame: up to 5 days
measure: Use of analgesia
timeFrame: throughout patient´s hospital stay, on average 6 days
measure: Trifecta outcomes of partial nephrectomy
timeFrame: 90 days
measure: Blood loss
timeFrame: Immediately after surgery
measure: Conversion to open surgery
timeFrame: Immediately after surgery
measure: Conversion to radical nephrectomy
timeFrame: Immediately after surgery
measure: Case cost
timeFrame: 90 days
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Department of Urology, University Medical Center Mannheim, University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Department of Urology, University Medical Center Mannheim, University of Heidelberg
name: Maximilian C. Kriegmair, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.