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Completed

NCT Number: NCT05377632

Comparing Two Different Approaches in Robotic-Assisted Renal Surgery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. detection of the renal artery

    Time frame: During procedure/surgery

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

Secondary outcomes

  1. Operative time

    Time frame: During procedure/surgery

    The time from [Skin Incision] to [Skin Closure] in minutes as documented in OR-Management Information System

  2. Robot docking time

    Time frame: During procedure/surgery

    The time from [Skin Incision] to [robot docking] in minutes as documented in OR-Spreadsheet.

  3. Instrument insertion time

    Time frame: During procedure/surgery

    The time from [Skin Incision] to [insertion of the last instrument] in minutes as documented in OR-Spreadsheet

  4. Off-console time

    Time frame: During procedure/surgery

    The time from [Skin Incision] to [start of first instrument movement by console surgeon] in minutes as documented in OR-Spreadsheet

  5. Ischemia time

    Time frame: During procedure/surgery

    The time from [Placement of clamp on artery] to [Release of clamp] in minutes indicated by the console surgeon documented by the anesthesiologist

  6. Surgical conversion to open surgery

    Time frame: During procedure/surgery

    Conversion from robotic to open surgery

  7. Surgical conversion to radical nephrectomy

    Time frame: During procedure/surgery

    Conversion partial to radical nephrectomy

  8. Intraoperative blood loss

    Time frame: During procedure/surgery

    Volume of blood loss during the surgical procedure in mL

  9. Console surgeons perception of Trocar placement and working space

    Time frame: During procedure/surgery

    Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)

  10. Side assistants perception of Trocar placement and working space

    Time frame: During procedure/surgery

    Assessment via The surgical rating score (Likert-scale, 1-5, higher scores mean a better outcome)

  11. Pain assessment

    Time frame: During the hospital stay (up to day 7)

    Assessment of pain level via the Visual Analogue Scale (VAS, 1-10, higher scores mean more pain)

  12. Pain Management

    Time frame: During the hospital stay (up to day 7)

    Documentation of pain management (according to the WHO Analgesic Ladder, 1-4, higher scores mean more intense pain treatment)

  13. Kidney function via the estimated glomerular filtration rate (eGRF)

    Time frame: During the hospital stay (up to day 7)

    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]

  14. Post operative complications

    Time frame: Day 30

    Any Clavien-Dindo I-V post-operative complication (standard classification for complication in surgery

  15. Length of stay Length of stay

    Time frame: During the hospital stay (up to day 7)

    Time from surgery to discharge in days [d]

  16. Procedure related readmissions

    Time frame: Day 30

    Readmission that can be linked to the (partial) nephrectomy, binary [Yes/No]

  17. Procedure related reoperations

    Time frame: Day 30

    Re-operation that can be linked to the partial nephrectomy, binary [Yes/No]

  18. Comprehensive Complication Index

    Time frame: Day 30

    Any complication that occurred within 30 days post surgery, Scale [from 0 (no complication) to 100 (death)]

Sponsors and collaborators

Lead sponsor

Lukas J Hefermehl

Other

Collaborators

  • Kantonsspital Baden

Registry information

Official study title

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

Acronym: PIONEER-OPT

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 17, 2022
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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