Comparing Two Different Approaches in Robotic-Assisted Renal Surgery (PIONEER-OPT)

Comparing the Modified Novel Trans-Retro Approach vs Conventional Retroperitoneal Approach in Robotic-Assisted Renal Surgery: An Open Label Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Renal Tumor
• Intervention / Treatment: Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN)

Detailed Description

The trans abdominal approach (TA) for total and partial nephrectomy (PN) has been widely adopted due to the easy trocar placement and the good working space. The retroperitoneal approach (RP) has gained popularity because the renal artery is often found fast and the operation remains in an anatomically separated space, making it preferable, especially for patients who underwent abdominal surgery in the past. However, both approaches face difficulties. Trocar placement for RP can be challenging, and the working space often is limited, while TA is impaired in cases of dorsal tumors and dissection of the renal artery can be challenging due to the anatomic localization dorsally to the renal vein. Up until now, no direct systematically and prospective comparison of these two approaches was performed.

The overall objective of this trial is to assess if the novel TR approach is superior to the conventional RP approach in performing robotic assisted (partial) nephrectomy. To date, no systematic, prospective, randomised study has been conducted on this topic and described in the literature.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Aargau
    • Baden, Canton of Aargau, Switzerland, 5404
      • Kantonsspital Baden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Renal vein tumor thrombus
• Pregnancy or suspected pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hybrid-Group; 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); 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.
Active Comparator: Retroperitoneal-Group; Robotic-assisted laparoscopic (partial) nephrectomy via the retroperitoneal access route	Procedure: Robotic-assisted laparoscopic partial nephrectomy (LPN) or laparoscopic nephrectomy (LN); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
detection of the renal artery	Time from first skin incision to detection of the renal artery [Time in minutes]	During procedure/surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	The time from [Skin Incision] to [Skin Closure] in minutes as documented in OR-Management Information System	During procedure/surgery
Robot docking time	The time from [Skin Incision] to [robot docking] in minutes as documented in OR-Spreadsheet.	During procedure/surgery
Instrument insertion time	The time from [Skin Incision] to [insertion of the last instrument] in minutes as documented in OR-Spreadsheet	During procedure/surgery
Off-console time	The time from [Skin Incision] to [start of first instrument movement by console surgeon] in minutes as documented in OR-Spreadsheet	During procedure/surgery
Ischemia time	The time from [Placement of clamp on artery] to [Release of clamp] in minutes indicated by the console surgeon documented by the anesthesiologist	During procedure/surgery
Surgical conversion to open surgery	Conversion from robotic to open surgery	During procedure/surgery
Surgical conversion to radical nephrectomy	Conversion partial to radical nephrectomy	During procedure/surgery
Intraoperative blood loss	Volume of blood loss during the surgical procedure in mL	During procedure/surgery
Console surgeons perception of Trocar placement and working space	Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)	During procedure/surgery
Side assistants perception of Trocar placement and working space	Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)	During procedure/surgery
Pain assessment	Assessment of pain level via the Visual Analogue Scale (VAS, 1-10, higher scores mean more pain)	During the hospital stay (up to day 7)
Pain Management	Documentation of pain management (according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment)	During the hospital stay (up to day 7)
Kidney function via the estimated glomerular filtration rate (eGRF)	Data will be gathered from routine examination, not a mandatory assessment (Lab value read-outs from in the clinical Information System) [ml/min/1,73 m2]	During the hospital stay (up to day 7)
Post operative complications	Any Clavien-Dindo I-V post-operative complication (standard classification for complication in surgery	Day 30
Length of stay Length of stay	Time from surgery to discharge in days [d]	During the hospital stay (up to day 7)
Procedure related readmissions	Readmission that can be linked to the (partial) nephrectomy, binary [Yes/No]	Day 30
Procedure related reoperations	Re-operation that can be linked to the partial nephrectomy, binary [Yes/No]	Day 30
Comprehensive Complication Index	Any complication that occurred within 30 days post surgery, Scale [from 0 (no complication) to 100 (death)]	Day 30

Collaborators and Investigators

• Sponsor: Lukas J Hefermehl
• Collaborators: Kantonsspital Baden
• Investigators: Principal Investigator: Lukas J Hefermehl, MD, Kantonsspital Baden

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 15, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: robotic surgery; renal tumor
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell; Health Care Facilities Workforce and Services; Health Personnel; Allied Health Personnel; Licensed Practical Nurses
• Other Study ID Numbers: PIONEER-OPTICS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that will be recorded in this study will be available on reasonable request from the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes