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Completed

NCT Number: NCT06056505

Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy

The primary objective is to determine if 3D modelling shortens total console operation time as a surrogate endpoint for clinical outcomes like perioperative complications and morbidity in robotic-assisted partial nephrectomy.

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Key information

Conditions

Kidney 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

Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie, Dresden, Saxony, Germany

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About this study

3DPN is a prospective, multicentre, randomised, controlled, two-armed, open trial to compare the 3D modelling with the 2D modelling in robotic-assisted partial nephrectomy. According to the randomisation the 3D or 2D modelling is used for patient information (before intervention) and for partial nephrectomy. A six-month follow-up visit is provided.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with kidney tumours ≤ 7cm and planned robotic-assisted partial nephrectomy with the DaVinci Surgical System
  • CT scan with contrast medium available
  • Age ≥ 18 years
  • Written informed consent

Exclusion criteria

  • History of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation)
  • Clinical suspicion of metastases (stage cN1/cM1)
  • Horseshoe kidney
  • Previous malignancy with ongoing or planned nephrotoxic chemotherapy
  • Multifocal kidney tumour
  • Von Hippel-Lindau syndrome and other hereditary kidney cancer syndromes
  • Patient is immunosuppressed (e.g., organ transplantation, leukaemia)
  • Tumor thrombus in Vena renalis or Vena cava inferior
  • Severe cognitive impairment
  • Pregnancy or lactation or women with desire for children
  • Patients under legal supervision or guardianship
  • Unable to give informed consent or suspected lack of compliance
  • Patients who decline data collection and storage for the main study

Treatment and study plan

partial kidney nephrectomy

Procedure

surgery for partial nephrectomy

DaVinci Robot

Device

device to perform the surgery for partial nephrectomy (not the intervention of interest)

Innersight 3D software

Device

investigational product to generate the 3D model

Primary outcomes

  1. Primary endpoint is the console operation time measured intra-op.

    Time frame: intra-operative

    Total console time is measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console.

Secondary outcomes

  1. Pre-operative - PRA-D

    Time frame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)

    Quality of the Physician-Patient Relationship - Evaluation of the German Version of the Patient Reactions Assessment (PRA-D); fifteen items with seven expressions from "I do not agree at all" to "I agree completely"

  2. Pre-operative - STOA

    Time frame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)

    STATE-TRAIT-Operations-Angst (STOA) for anxiety; thirty items with four expressions from "not at all" to "very"

  3. Pre-operative - APAIS

    Time frame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)

    Amsterdam Preoperative Anxiety and Information Scale (APAIS) for anxiety; six items with five expressions from "Do not agree at all" to "strongly agree"

  4. Pre-operative - NRS

    Time frame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)

    numeric rating scale (NRS) for anxiety; numeric scale form one to ten (not afraid at all to very big anxiety)

  5. Pre-operative - Patient satisfaction questionnaire

    Time frame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)

    Patient satisfaction questionnaire regarding the informed consent process

  6. Peri-operative - Hilar clamping technique

    Time frame: Visit 2: during operation

    Hilar clamping technique (three levels: global ischemia, selective ischemia, clampless)

  7. Peri-operative - Warm ischaemia time (WIT)

    Time frame: Visit 2: during operation

    Warm ischaemia time (WIT) in minutes

  8. Peri-operative - Estimated blood loss

    Time frame: Visit 2: during operation

    Estimated blood loss in ml

  9. Peri-operative - Number of transfusions

    Time frame: Visit 2: during operation

    Number of transfusions

  10. Peri-operative - Total Operative time

    Time frame: Visit 2: during operation

    Total Operative time measured from incision to suture in minutes

  11. Peri-operative - Number of conversions to open surgery

    Time frame: Visit 2: during operation

    Number of conversions to open surgery

  12. Peri-operative - Number of conversions to radical nephrectomy

    Time frame: Visit 2: during operation

    Number of conversions to radical nephrectomy

  13. Peri-operative - Surgeon confidence level

    Time frame: Visit 2: during operation

    Surgeon confidence level evaluated by questionnaire survey; five questions with five expressions from "excellent" to "very bad"

  14. Post-operative - Positive margin status

    Time frame: Visit 3: after operation up to 6 weeks

    Positive margin status, range: R0, R1, R2, RX

  15. Post-operative - Creatinine

    Time frame: from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation

    Creatinine in µmol/l

  16. Post-operative - eGFR

    Time frame: from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation

    eGFR (CKD-EPI) in ml/min/1,73m²

  17. Post-operative - Patient length of stay

    Time frame: from day of hospitalization (up to 7 days before operation) until the day of discharge (up to 6 days)

    Patient length of stay in days

Other outcomes

  1. Safety endpoints - Post-op complications

    Time frame: from the end of the operation until the day of discharge (up to 6 days)

    Post-op complications categorized by Clavien-Dindo classification (grad 1 to 5)

  2. Safety endpoints - Number of operation- or kidney-related readmissions

    Time frame: Visit 4: six months after operation

    Number of operation- or kidney-related readmissions

  3. Safety endpoints - Number of AEs, SAEs

    Time frame: Visit 4: six months after operation

    Number of AEs, SAEs

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - A Multicentre, Randomised, Controlled Trial

Acronym: 3DPN

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
May 5, 2026

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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