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

NCT03900364 | Completed

• 1 other identifier: AT2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Renal Cell; Renal Malignant Tumor; Renal Cyst; Renal Tumor

Keywords

partial nephrectomy; robot-assisted partial nephrectomy; laparoscopic partial nephrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Operation time

  one year

• Ischemia time

  one year

• Blood loss

  one year

• Postoperative pain

  one year

• Kidney function

  one year

Study Arms (2)

robot-assisted partial nephrectomy

OTHER

partial nephrectomy performed with the da Vinci Surgical System

Procedure: partial nephrectomy

laparoscopic partial nephrectomy

OTHER

partial nephrectomy performed with conventional laparoscopic surgery

Procedure: partial nephrectomy

Interventions

partial nephrectomy PROCEDURE

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.

laparoscopic partial nephrectomy; robot-assisted partial nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Salzburger Landeskliniken: lead

Study Sites (1)

Uniklinikum Salzburg, Department for Urology and Andrology

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: April 3, 2019
• Study Start: September 3, 2018
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

AU (1)