Robotic-assisted vs. Open Partial Nephrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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ROBOtic-assisted Versus Conventional Open Partial Nephrectomy: a Single-center, Open-label, Randomized Controlled Feasibility Trial

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Procedure: Partial nephrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic-assisted partial nephrectomy<br>Partial nephrectomy will be performed using a robotic-assisted laparoscopic approach. | Procedure: Partial nephrectomy<br>* Partial nephrectomy for localized kidney cancer as curative treatment.<br>* Other names: nephron-sparing surgery;|
| Active Comparator: Open partial nephrectomy<br>Partial nephrectomy will be performed using an open retroperitoneal approach. | Procedure: Partial nephrectomy<br>* Partial nephrectomy for localized kidney cancer as curative treatment.<br>* Other names: nephron-sparing surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Proportion of randomized patients in relation to the eligible ones. | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications | 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 | throughout patient´s hospital stay, on average 6 days | 
| Postoperative complications | 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 | 90 days | 
| Self-reported generic health status | 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) | 90 days | 
| Self-reported quality of life assessment of cancer patients | 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) | 90 days | 
| Self-reported quality of life in patients with kidney disease | 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) | 90 days | 
| Self-assessment of depression in patients ≥ 65 years old | 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. | 90 days | 
| Self-evaluation of cancer disease´s influence on elderly patients´ life | 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. | 90 days | 
| Self-assessment of comorbidity in elderly patients | 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) | 90 days | 
| Postoperative self-reported quality of life | 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. | 90 days | 
| Kidney function - creatinine | postoperative change in kidney function - creatinine (measured in mg/dL) | 90 days | 
| Kidney function - GFR | postoperative change in kidney function - glomerular filtration rate (measured in mL/min) | 90 days | 
| Length of hospital stay | Total time of hospital stay | throughout patient´s hospital stay, on average 6 days | 
| Operative time | Surgery duration | Immediately after surgery | 
| Inflammatory response - leucocytes | postoperative course of inflammatory parameters (leucocytes, unit of measure: white cells x10^9/L) | throughout patient´s hospital stay, on average 6 days | 
| Inflammatory response - C-reactive protein | postoperative course of inflammatory parameters (c-reactive protein, measured in mg/L) | throughout patient´s hospital stay, on average 6 days | 
| Inflammatory response | postoperative course of inflammatory parameters (IL-6, TNF-α, IL-1β, VEGF, measured in ng/L) | throughout patient´s hospital stay, on average 6 days | 
| Surgical ergonomics | Surgeons will be asked to evaluate localized muscle pain on a scale from 0 to 10, 10 indicating extreme discomfort | Immediately after surgery | 
| Surgical ergonomics | Surgeons will be asked to fill NASA TLX questionnaire (NASA Task Load Index). Range: 0-100, high scores indicate a high task load | During surgery | 
| Resection status | Rate of R0/R1 status in each arm | up to 5 days | 
| Use of analgesia | Need for pain medications | throughout patient´s hospital stay, on average 6 days | 
| Trifecta outcomes of partial nephrectomy | Trifecta is defined as no major complication, R0-resection status and ischemia time of less than 25 minutes | 90 days | 
| Blood loss | Blood loss during surgery | Immediately after surgery | 
| Conversion to open surgery | Rate of conversion to open surgery | Immediately after surgery | 
| Conversion to radical nephrectomy | Rate of conversion to radical nephrectomy | Immediately after surgery | 
| Case cost | DRG-related case costs per arm | 90 days |