Open vs Robotic Assisted Partial Nephrectomy

Renal Cancer Clinical Trial

— OpeRa  

Official title:

Open vs Robotic Assisted Partial Nephrectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03849820
• Other study ID #: OpeRa-2018
• Status: Terminated
• Phase: N/A
• Start date: March 12, 2019
• Est. completion date: October 25, 2022

Study information

• Verified date: April 2023
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate that Robotic-Assisted partial nephrectomy is superior to Open partial nephrectomy in reducing the number of 30 day post-operative complications (Clavien-Dindo Type I-V) for patients with intermediate to high complexity kidney tumors.

Description:

Partial nephrectomy is the surgical removal of a kidney tumor while unaffected tissue remains intact so that the kidney function is maintained as far as possible. The more radical procedure would be the complete removal of the kidney, which is not examined in this trial. Surgery will be randomized either to an open technique involving a large incision or the robotic assisted technique with a few small incisions (keyhole surgery). With robotic assisted surgery the movements of the surgeon are translated into the movement of the instruments. It is not clear which of the two procedures, open or robotic assisted, has less complications. It is expected that these are different due to the different level of invasiveness and the level of direct access to the organ. This study aims to show that robotic assisted surgery results in less complications than open surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 247
• Est. completion date: October 25, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older
• Patient with a renal tumor that is a candidate for OPEN surgery and robotic assisted surgery (RAS) partial nephrectomy (PN)
• R.E.N.A.L. score = 7
• eGFR = 50 ml/min/1.73 m²
• Anticoagulation is accepted according to the surgeon's practice

Exclusion Criteria:

• Solitary kidney or functionally solitary kidney
• Prior surgery at the affected kidney excluding endoscopic kidney stone surgery
• Bilateral tumors
• Multiple renal tumors requiring excision
• Renal vein tumor thrombus
• Likely insufficient volume of remaining parenchyma after partial nephrectomy to maintain viable kidney remnant
• Metastatic disease with life expectancy of less than 1 year
• Pregnancy or suspected pregnancy
• Planned concomitant procedure
• Subject who is unable or unwilling to comply with the protocol requirements
• Subject considered to be from a vulnerable population according to IS0 14155:2011

Related Conditions & MeSH terms

• Kidney Neoplasms
• Renal Cancer

Intervention

Device:
• Robotic-assisted partial nephrectomy
Application of the da Vinci surgical robot to assist the partial nephrectomy

Other:
• Open partial nephrectomy
Open surgery to conduct the partial nephrectomy

Locations

Country	Name	City	State
Germany	Department of Urology, University Hospital Düsseldorf	Düsseldorf
Germany	Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid	Essen
Germany	Department of Urology, University Hospital Freiburg	Freiburg
Germany	Universitätsklinik und Poliklinik für Urologie	Halle
Germany	Universitätsklinikum Heidelberg, Urologische Klinik	Heidelberg
Germany	Klinik für Urologie, Marien Hospital Herne	Herne
Germany	Department of Urology - Universitätsklinikum des Saarlandes	Homburg
Germany	Department of Urology, University Hospital Jena	Jena
Germany	Klinik für Urologie, Marien-Hospital Marl	Marl
Germany	Department of Urology, Klinikum rechts der Isar der Technischen Universität	Munich
Germany	Dept. of Urology, University Hospital Tübingen	Tübingen
Germany	Helios Universitätsklinkum Wuppertal - Department of Urology	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day complications	Any complication that occurred within 30 days post surgery	Day of surgery to 30th post operative day
Secondary	Operative time	Timing of surgical steps in the OR	Day of surgery
Secondary	Ischemia time	Period in which the kidney has no blood supply	Day of surgery
Secondary	Surgical radicality conversions	Conversion from robotic to open, partial to radical	Day of surgery
Secondary	Intraoperative blood loss	Volume of blood loss during the surgical procedure	Day of surgery
Secondary	Pain assessment	Assessment of pain level via the Brief Pain Inventory (BPI)	Baseline until Day 90
Secondary	Pain Medication	Recording pain medication	Baseline until Day 90
Secondary	Neuropathic pain	Development of neuropathic pain via the DN-4 Patient interview questions	Baseline and Day 30 and Day 90
Secondary	Kidney function via the estimated glomerular filtration rate (eGRF)	Data will be gathered from routine examination, not a mandatory assessment	Baseline until Day 5 / discharge (whatever is earlier)
Secondary	Post operative complications	Any Clavien-Dindo I-V post-operative complication	Day 90
Secondary	Length of stay	Time from surgery to discharge	Discharge
Secondary	Procedure related readmissions	Readmission that can be linked to the partial nephrectomy	Day 90
Secondary	Procedure related reoperations	Re-operation that can be linked to the partial nephrectomy	Day 90
Secondary	Quality of recovery from the intervention	Quality of recovery questionnaire QoR-9	Baseline until Day 5 / discharge (whatever is earlier)
Secondary	Quality of life questionnaire, generic measure	EQ-5D 5L	Baseline until Day 90
Secondary	Quality of life questionnaire, cancer patient specific	EORTC QLQ-C30	Baseline until Day 90
Secondary	Overall survival	time from surgery to death from any cause	Day of surgery to 5 years
Secondary	Disease specific survival	time from surgery to death due to kidney cancer	Day of surgery to 5 years
Secondary	Disease free survival	time from surgery to first documented recurrence of renal cell carcinoma as defined by the investigator	Day of surgery to 5 years
Secondary	Local recurrence free survival	Time from surgery to the first documented local recurrence e.g. tumor in the operated kidney or in the immediate vicinity (e.g. perirenal fat) at the surgical site. Portside recurrence / incisional, surgical access site recurrence to the affected kidney would also be considered as a local recurrence.	Day of surgery to 5 years
Secondary	Comprehensive Complication Index	Any complication that occurred within 30 days post surgery	Day of surgery to 30th post operative day