Robotic-assisted vs. Open Partial Nephrectomy

Renal Cell Carcinoma Clinical Trial

— ROBOCOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04534998
• Other study ID #: 2020-542N
• Status: Recruiting
• Phase: Phase 2
• Start date: June 15, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: September 2021
• Source: Universitätsmedizin Mannheim
• Contact: Karl-Friedrich Kowalewski, M.D.
• Phone: 00496213832201
• Email: karl-friedrich.kowalewski[@]umm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 15, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Procedure:
• Partial nephrectomy
Partial nephrectomy for localized kidney cancer as curative treatment.

Locations

Country	Name	City	State
Germany	Department of Urology, University Medical Center Mannheim, University of Heidelberg	Mannheim	Baden-Württemberg

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim	Dietmar Hopp Stiftung, Institute of Medical Biometry and Informatics, University of Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Proportion of randomized patients in relation to the eligible ones.	15 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Kidney function - creatinine	postoperative change in kidney function - creatinine (measured in mg/dL)	90 days
Secondary	Kidney function - GFR	postoperative change in kidney function - glomerular filtration rate (measured in mL/min)	90 days
Secondary	Length of hospital stay	Total time of hospital stay	throughout patient´s hospital stay, on average 6 days
Secondary	Operative time	Surgery duration	Immediately after surgery
Secondary	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
Secondary	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
Secondary	Inflammatory response	postoperative course of inflammatory parameters (IL-6, TNF-a, IL-1ß, VEGF, measured in ng/L)	throughout patient´s hospital stay, on average 6 days
Secondary	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
Secondary	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
Secondary	Resection status	Rate of R0/R1 status in each arm	up to 5 days
Secondary	Use of analgesia	Need for pain medications	throughout patient´s hospital stay, on average 6 days
Secondary	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
Secondary	Blood loss	Blood loss during surgery	Immediately after surgery
Secondary	Conversion to open surgery	Rate of conversion to open surgery	Immediately after surgery
Secondary	Conversion to radical nephrectomy	Rate of conversion to radical nephrectomy	Immediately after surgery
Secondary	Case cost	DRG-related case costs per arm	90 days