a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy

Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy: A Prospective, Randomised, Single-blind Trial Comparing Two Surgical Techniques

In this trial the investigators want to examine and compare oncological and surgical outcomes of two surgical techniques in a prospective, randomised, single-blind trial. Therefore the investigators are going to include 30 patients with a renal mass who need surgical treatment. When they fulfill the inclusion criteria they get randomised either for robot-assisted partial nephrectomy or laparoscopic partial nephrectomy. Primary endpoint is the oncological outcome (residual tumor classification, TNM classification), secondary endpoints are operation time, time of ischemia, blood loss, pain after surgery, kidney function, complications and hospital stay.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Renal Cell; Renal Tumor; Renal Cyst; Renal Malignant Tumor
• Intervention / Treatment: Procedure: partial nephrectomy

Detailed Description

All patients taking part in the study are first given a R.E.N.A.L. nephrometry score. Based on that score they are allocate to either of :

cohort I (low complexity of the tumour) or cohort II (intermediate complexity of the tumour).

Thereafter, the patient will be randomly placed into either to laparoscopic partial nephrectomy or robotic-assisted partial nephrectomy. Both these surgical techniques are well established and standardized procedures to remove a renal mass.

Preoperatively, the preparation is nearly the same for both techniques. The patient is positioned in flank position with the affected side up.

Thereafter:

Pneumoperitoneum is achieved with a Veress needle and trocars which are placed under direct vision. The only difference between the two techniques is the number of trocars, performing the laparoscopic partial nephrectomy three or four ports are used, performing the robotic-assisted partial nephrectomy five ports are used.

Intraabdominal, the kidney is exposed by incising along the Toldt line to moblize the colon. After exposing the ureter and the gonadal vein dissection is continued proximally toward the renal hilum. Following this, Gerota's fascia is incised to expose the tumour and the surrounding renal capsule. Now the renal artery has to be clamped to avoid bleeding followed by excision of the tumour. The surgery takes about three hours, the complication rate is more the same for both techniques.

Primary endpoint is the resection margin to see if there are any difference between the two surgical techniques.

Information about the resection margin and pathological staging will be given through our pathological department. The histological examination normally takes about five to seven days.

Further parameters are taken by following schema:

Information about age, sex, body mass index, other diseases and medication is documented on the day of inpatient admission.

Blood samples for haemoglobin and kidney function are taken at the day of inpatient admission, four hours after surgery, first day after surgery and the day of discharge from hospital.

The duration of surgery is documented throughout the operative protocol. R.E.N.A.L Nephrometry score is evaluated preoperative, to be able to compare the complexity of surgery.

Renal ischemia is documented throughout the operative protocol. Blood loss is documented during surgery. Pain is documented with the aid of the visual analogue scale (VAS Scale). This will be evaluated four hours after surgery, day one after surgery, day two after surgery and on the day of discharge from hospital.

Complications are documented with the aid of the clavien-dindo classification. Three follow-ups will be performed. The first follow-up will be held two weeks after surgery to discuss the histological result and examine haemoglobin, kidney function and pain. The second follow-up will be held six months after surgery, the third follow-up 12 months after surgery. At this time a re-examination again haemoglobin and kidney function will be performed as well as a computed tomography.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Uniklinikum Salzburg, Department for Urology and Andrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• minimum age of 18 years
• solid renal mass suspicious for renal cell carcinoma or at least Bosniak III cyst
• signed informed consent

Exclusion Criteria:

• performed kidney surgery at the same side
• Pregnancy
• RENAL Nephrometry score III

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: robot-assisted partial nephrectomy; partial nephrectomy performed with the da Vinci Surgical System	Procedure: partial nephrectomy; Partial nephrectomy is the standard technique for organ-sparing resection of renal tumors. The EAU Guidelines recommend partial nephrectomy to all patients with T1 tumours and can be performed either with an open, pure laparoscopic or robot-assisted approach, based on surgeon's expertise and skills.
OTHER: laparoscopic partial nephrectomy; partial nephrectomy performed with conventional laparoscopic surgery	Procedure: partial nephrectomy; Partial nephrectomy is the standard technique for organ-sparing resection of renal tumors. The EAU Guidelines recommend partial nephrectomy to all patients with T1 tumours and can be performed either with an open, pure laparoscopic or robot-assisted approach, based on surgeon's expertise and skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with R0 status	The tumor status following further treatment is described by the residual tumor classification. R0 means no residual tumor, R1 means microscopic residual tumor. The investigators are going to examine if there are any significant differences concerning tumor status between these two surgical techniques	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	time of surgery (in minutes)	one year
Ischemia time	Time of warm ischemia during laparoscopic or robot-assisted partial nephrectomy	one year
Blood loss	The amount of blood loss during performing partial nephrectomy	one year
Postoperative pain	Postoperative pain is going to be documented with the aid of the visual analogue scale. The visual analogue scale is a validated, subjective measure for pain. With the aid of a scale from zero to ten which represents a continuum between 'no pain' (0) and 'worst pain' (10) the subjective pain of each participant will be evaluated. This will be done four hours after surgery, day one after surgery, day two after surgery and on the day of discharge from hospital.	one year
Kidney function	Before and after surgery blood samples are taken to evaluate the kidney function with the aid of Serum creatinine and the glomerular Filtration rate	one year
Complications	Postoperative complications evaluated by 'clavien-dindo' classification	one year
Hospital stay	The length of hospital stay	one year

Collaborators and Investigators

• Sponsor: Salzburger Landeskliniken

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2018
• Primary Completion (ACTUAL): October 15, 2020
• Study Completion (ACTUAL): October 15, 2020

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (ACTUAL): April 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: partial nephrectomy; laparoscopic partial nephrectomy; robot-assisted partial nephrectomy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: AT2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No