Comparing Two Different Approaches in Robotic-Assisted Renal Surgery

NCT05377632 | Completed

• 1 other identifier: PIONEER-OPTICS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the novel TR approach is superior to the standard RP approach. The anticipated study outcome is a time saving of at least 30% from first skin incision to detection of the renal artery compared to the conventional RP approach, and also a better workspace perception by the operating surgeon.

Conditions

Renal Tumor

Keywords

robotic surgery; renal tumor

Outcome Measures

Primary Outcomes (1)

• detection of the renal artery

  Time from first skin incision to detection of the renal artery \[Time in minutes\]

  During procedure/surgery

Secondary Outcomes (18)

• Operative time

  During procedure/surgery

• Robot docking time

  During procedure/surgery

• Instrument insertion time

  During procedure/surgery

• Off-console time

  During procedure/surgery

• Ischemia time

  During procedure/surgery

Study Arms (2)

Hybrid-Group

ACTIVE COMPARATOR

Laparoscopic and Robotic-assisted combined (partial) nephrectomy via the hybrid (trans-peritoneal and retroperitoneal) access route

Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)

Retroperitoneal-Group

ACTIVE COMPARATOR

Robotic-assisted laparoscopic (partial) nephrectomy via the retroperitoneal access route

Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)

Interventions

Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) PROCEDURE

laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN) include bilateral tumors or tumors in a solitary kidney. Relative indications include familial renal cancer syndromes such as Von Hippel-Lindau, hereditary leiomyomatosis, or hereditary papillary renal cell carcinoma. Patients with chronic kidney disease are generally offered nephron sparing surgery for hope of future renal function preservation. This reasoning also applies to those patients with preexisting diseases that may threaten a solitary kidney such as uncontrolled diabetes and hypertension.

Hybrid-Group; Retroperitoneal-Group

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Patient with a renal tumor or non-functionally kidney that is a candidate for robotic assisted surgery (RAS) nephrectomy or partial nephrectomy (PN)
• Informed Consent as documented by signature (Appendix Informed Consent Form)

You may not qualify if:

• Renal vein tumor thrombus
• Pregnancy or suspected pregnancy

Sponsors & Collaborators

• Lukas J Hefermehl: lead
• Kantonsspital Baden: collaborator

Study Sites (1)

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Licensed Practical Nurses

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

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Lukas J Hefermehl, MD

  Kantonsspital Baden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 17, 2022
• Study Start: May 15, 2022
• Primary Completion: December 15, 2024
• Study Completion: January 15, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)