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Female Urogenital Diseases and Pregnancy Complications

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The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney.

The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney.

partial kidney nephrectomy

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

DaVinci Robot

investigational product to generate the 3D model

Innersight 3D software

Sigrun Holze, Dr.

Nicole Köppe-Bauernfeind

Christian Thomas, Prof.

Jens-Uwe Stolzenburg, Prof.

Hoang Minh Do, PD Dr.

Matthias Oelke, Prof.

Stefan Siemer, Prof.

Martin Schostak, Prof.

Axel Haferkamp, Prof.

Karl-Friedrich Kowalewski, PD Dr.

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.

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.

Parallel Assignment randomization to 3D or 2D modelling

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

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

According to the recommendations on data sharing by the International Committee of Medical Journal Editors (ICMJE) data resulting from the 3DPN trial will be made available to the scientific community.

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

Number of operation- or kidney-related readmissions

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

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"

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

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

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

Patient satisfaction questionnaire regarding the informed consent process

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

Total Operative time measured from incision to suture in minutes

Number of conversions to radical nephrectomy

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

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

Spots Global Cancer Trial Database for kidney tumours