Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

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

University of Leipzig

Prof. Dr.

Urinary Bladder Neoplasms

Urinary Bladder Diseases

Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.

Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.

Standard of care removal of urinary bladder.

Open radical cystectomy

Standard of care removal of urinary bladder using DaVinci robot.

Robotic assisted radical cystectomy

DaVinci robot

Dipen J Parekh, MD

This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference in the risk between the two standard procedures. However, despite these potential advantages, true comparison between the open and robotic technique with regards to long term cancer related and functional outcomes has not been accomplished because previous studies did not compare patients of equal health status. The researchers hope to learn whether or not patients undergoing RARC recover more quickly than or at the same rate as patients undergoing an open radical cystectomy while having non inferior cancer related outcomes. This study is funded by the National Institutes of Health (NIH).

Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy

Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

Progression will be determined by the treating physician using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.

Evaluated are the number of participants with positive surgical, bladder, and urethral margins. Positive margin is defined as presence of tumor cells at the edge of the dissected tissue.

Evaluated are the number of participants requiring extended or standard lymph node dissection

Functional Assessment of Cancer Therapy- Vanderbilt Cystectomy Index (FACT-VCI) scores range is 0-168 which is sum of physical, emotional, wellbeing, and FACTS Bl Cys. higher scores=better QOL.

Post surgical complications will be evaluated using the Clavien grading system with scores ranging from 0-5 with the higher number indicating increased post-surgical complications.

Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml.

Number of participants requiring peri, intra, and post operative blood transfusion.

Number of days of post operative length of hospital stay will be evaluated

Length of minutes of cystectomy procedure

Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL)

Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence.

Progression will be determined by the treating physician using the RECIST Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.

The SF-8 consists of two component summary scores; physical (PCS) and mental component summary (MCS). They are scored by weighting each score to a norm-based scoring model. The total scores will be reported as a percentile with higher score indicating better quality of health.

Total number of participants requiring Intra-operative fluid requirement. (blood+plasma+platelets) Note: In robotic group 1 participant received both plasma and platelets and 1 other received platelets in addition to blood transfusion. In the open group 5 participants received plasma in addition to blood transfusion.

Total postoperative analgesic requirements in milli grams

Serum creatinine will be reported in milligrams per deciliters (mg/dL).

Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence.

The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer.

The TUG test is measured in seconds. Patients will be timed as they rise from a standard chair, walk 3 meters, turn, walk back, and sit again.

FACT-VCI consists of eight domains: Five subscale scores (physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing, and FACT for patients with Bladder Cancer following Cystectomy \[FACT-BL-Cys\]) and three derived scores (trial outcome index), FACT-General form (FACT-G), and FACT-BL-Cys Total.The ranges of scores for each domain are as follows: 0-28 for physical, social, and functional wellbeing; 0-24 for emotional wellbeing; 0-60 for FACT-BL-Cys; 0-116 for FACT-VCI Trial Outcome Index (sum of physical wellbeing, functional wellbeing, and FACT-BL-Cys scores); 0-108 for FACT-G (sum of physical, social, emotional, and functional wellbeing scores); and 0-168 for FACT-BL-Cys Total (sum of physical, social, emotional, and functional wellbeing scores, and FACT-BL-Cys).The higher score indicates increased wellbeing.

Fixed and variable costs associated with the procedure.

National Cancer Institute (NCI)

University of Miami

Chairman of Urology

Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.

Open Cystectomy

Robotic Assisted Radical Cystectomy

Standard of care treatment, open cystectomy

Standard of care treatment, robotic assisted radical cystectomy

Total

Age, Continuous

Data analysis completed for participants who finished the study as per protocol.

Sex: Female, Male

Data analysis were completed only for the participants that completed the study.

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dipen Parekh, MD

Open Radical Cystectomy

Standard of care treatment using the DaVinci robot.

Percentage of Participants With 2-year Progression Free Survival (PFS)

Positive surgical margins

Positive bladder margins

Positive urethral margin

Standard of care treatment, robotic assisted radical cystectomy using the DaVinci robot

Number of Participants With Positive Margins

1 participant in the RARC group did not have lymph node dissection.

Number of Participants Requiring Lymph Node Dissection

Baseline Visit

3 Month Visit

6 Month Visit

Not all enrolled participants completed the QOL questionnaires.

Quality of Life (QOL) Outcomes

Clavien grade 0

Clavien grade I

Clavien grade II

Clavien grade III

Clavien grade IV

Clavien grade V

90 day complication using Clavien Grading system

Number of Participants With Post-surgical Complications

EBL data was not available on 3 of the open radical cystectomy and 2 of the RARC participants.

Amount of Estimated Blood Loss (EBL) in ml

Perioperative transfusion

Intraoperative transfusion

Postoperative transfusion

Standard of care treatment, robotic assisted radical cystectomy using DaVinci robot

Not all participants in the study required blood transfusion and not all blood transfusion data was available.

Number of Participants Requiring Blood Transfusion

Not all length of stay data is available for all the study participants.

Number of Days of Post Operative Length of Hospital Stay

The length of operative time is not available for all participants.

Length of Operative Time

Baseline (Hb)

6-weeks (Hb)

3-months (Hb)

6-months (Hb)

12-months (Hb)

24-months (Hb)

36-months (Hb)

Baseline (Albumin)

6-weeks (Albumin)

3-months (Albumin)

6-months (Albumin)

12-months (Albumin)

24-months (Albumin)

36-months (Albumin)

Number of participants included was based on the data available at specific time points.

Laboratory Values

Baseline

1-month

3-months

6-months

Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.

Open radical cystectomy: Standard of care removal of urinary bladder.

Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.

Robotic assisted radical cystectomy: Standard of care removal of urinary bladder using DaVinci robot.

DaVinci robot: DaVinci robotic surgical system.

Number of participants changes depending on their data availability at different time points.

Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire

Percentage of Participants With 3-year Progression Free Survival (PFS)

Baseline (PCS)

3-months (PCS)

6-months(PCS)

Baseline (MCS)

3-months (MCS)

6-months(MCS)

Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire

Number of participants included was based on the data available at specific time point.

Total Number of Participants Requiring Intra-operative Fluid Requirement

Total Postoperative Analgesic Requirements

6-weeks

12-months

24-months

36-months

Creatinine Value.

Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire

Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test

Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test

Physical Wellbeing baseline

Physical Wellbeing 3 months

Physical Wellbeing 6 months

Social Wellbeing baseline

Social Wellbeing 3 months

Social Wellbeing 6 months

Emotional Wellbeing baseline

Emotional Wellbeing 3 months

Emotional Wellbeing 6 months

Functional Wellbeing baseline

Functional Wellbeing 3 months

Functional Wellbeing 6 months

FACT-BL-Cys Baseline

FACT-BL-Cys 3 months

FACT-BL-Cys 6 months

Trial outcome index Baseline

Trial outcome index 3 months

Trial outcome index 6 months

FACT-G baseline

FACT-G 3 months

FACT-G 6 months

FACT-BL-Cys Total baseline

Not all participants completed the questionnaire at the different visits.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy	NCT06056505	Kidney Tumor	partial kidney ... DaVinci Robot Innersight 3D s...	18 Years -	University of Leipzig
Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial	NCT01157676	Bladder Cancer ...	Open radical cy... Robotic assiste... DaVinci robot	18 Years -	University of Miami

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