Robotic-assisted vs. Open Partial Nephrectomy

Phase 2

• Conditions: Renal Cell Carcinoma
• Interventions: Procedure: Partial nephrectomy

• Registration Number: NCT04534998
• Lead Sponsor: Universitätsmedizin Mannheim

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.

Study Timeline

• Study Start: 2020-06-15
• Study First Submitted: 2020-08-16
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-13
• Primary Completion: 2021-12-15
• Study Completion: 2022-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open partial nephrectomy	Partial nephrectomy	Partial nephrectomy will be performed using an open retroperitoneal approach.
Robotic-assisted partial nephrectomy	Partial nephrectomy	Partial nephrectomy will be performed using a robotic-assisted laparoscopic approach.

Primary Outcome Measures

Name	Time	Method
Recruitment rate	15 months	Proportion of randomized patients in relation to the eligible ones.

Secondary Outcome Measures

Name	Time	Method
Use of analgesia	throughout patient´s hospital stay, on average 6 days	Need for pain medications
Perioperative complications	throughout patient´s hospital stay, on average 6 days	Measured with 1) the comprehensive complication index (CCI), on a scale from 0 (no complications) to 100 (death) and 2) the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death
Length of hospital stay	throughout patient´s hospital stay, on average 6 days	Total time of hospital stay
Inflammatory response	throughout patient´s hospital stay, on average 6 days	postoperative course of inflammatory parameters (IL-6, TNF-α, IL-1β, VEGF, measured in ng/L)
Postoperative self-reported quality of life	90 days	Participants will evaluate their postoperative quality of life on a 0-100 scale, higher scores indicating a better quality of life and return to daily life activities.
Resection status	up to 5 days	Rate of R0/R1 status in each arm
Blood loss	Immediately after surgery	Blood loss during surgery
Conversion to open surgery	Immediately after surgery	Rate of conversion to open surgery
Self-reported quality of life in patients with kidney disease	90 days	Patients will assess the influence of their kidney disease on everyday activities, work status, social interactions, mental and physical health making use of KDQOL-SF (Kidney Disease Quality of Life Short Form), ranging from 0 ("worst possible health") to 10 ("best possible health")
Kidney function - creatinine	90 days	postoperative change in kidney function - creatinine (measured in mg/dL)
Trifecta outcomes of partial nephrectomy	90 days	Trifecta is defined as no major complication, R0-resection status and ischemia time of less than 25 minutes
Postoperative complications	90 days	Measured with 1) the comprehensive complication index (CCI), on a scale from 0 (no complications) to 100 (death) and 2) the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death
Kidney function - GFR	90 days	postoperative change in kidney function - glomerular filtration rate (measured in mL/min)
Conversion to radical nephrectomy	Immediately after surgery	Rate of conversion to radical nephrectomy
Case cost	90 days	DRG-related case costs per arm
Self-reported generic health status	90 days	Patient-reported generic health status using EQ-5D-5L(EuroQol-5D-5L) questionnaire (the scale ranges from 0 to 100, with 100 representing the highest health status)
Self-reported quality of life assessment of cancer patients	90 days	Cancer patients will be reporting their quality of life making use of the questionnaire QLQ-C30 (Quality of Life Questionnaire C30) (range 0-100, high scores represent a better quality of life)
Self-assessment of depression in patients ≥ 65 years old	90 days	Elderly patients (≥ 65 years old) will report their depression symptoms filling GDS (Geriatric Depression Scale) questionnaire, ranging from 0 to 30, with 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".
Self-evaluation of cancer disease´s influence on elderly patients´ life	90 days	Elderly patients (≥ 65 years old) will evaluate the influence of their cancer disease on their life (activities of daily living, cognition, mood, nutritional status, mobility, polypharmacy and social support), on a scale ranging from 0 to 17, 17 indicating the best outcome possible on quality of life.
Self-assessment of comorbidity in elderly patients	90 days	Elderly patients (≥ 65 years old) will make use of SCQ (Self-Administered Comorbidity Questionnaire) to assess common comorbidities; a higher score indicates higher comorbidities (range 0-39)
Operative time	Immediately after surgery	Surgery duration
Inflammatory response - leucocytes	throughout patient´s hospital stay, on average 6 days	postoperative course of inflammatory parameters (leucocytes, unit of measure: white cells x10\^9/L)
Inflammatory response - C-reactive protein	throughout patient´s hospital stay, on average 6 days	postoperative course of inflammatory parameters (c-reactive protein, measured in mg/L)
Surgical ergonomics	During surgery	Surgeons will be asked to fill NASA TLX questionnaire (NASA Task Load Index). Range: 0-100, high scores indicate a high task load

Trial Locations

Locations (1)

Department of Urology, University Medical Center Mannheim, University of Heidelberg; 🇩🇪 Mannheim, Baden-Württemberg, Germany