Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.

EinsteinVision 3D visualization system

The aim of the study is collecting clinical data on the learning curve of different surgeons using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.

Prostatectomies Using Einstein Vision® 3D

Prospective, Multi-centre, Non-interventional Trial on Laparoscopic Radical PROSTatectomies Using EinsteinVISion® 3D Visualization System

learning curve of different surgeons with diverse level of experience using EinsteinVision® 3D visualization system

(e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings)

using a questionnaire at the beginning (First Patient In) and the end of the study (Last Patient In)

Pre- and postoperative patient's quality of life using the questionnaire EQ-5D-5L

The following dimensions are assessed:

* Mobility
* Self-care
* Usual activities
* Pain / discomfort
* Anxiety / depression
* Health

using a questionnaire containing different dimensions and a 5-point assessment level (Likert Scale: 1 = excellent, 5 = unacceptable).

The following dimensions are assessed:

* Control
* Expenditure of energy
* Image quality
* Overall satisfaction

using a 10-point assessment level (1 = completely dissatisfied, 10 = completely satisfied)

Aesculap AG

Nathan Lawrentschuk, MBBS,PhD, FRACS

Farleigh Reeves, MBBS, PhD

Damien Bolton

Lih-Ming Wong

Marlon Perara

Nathan Lawrentschuk

Surgical notes are detailed reports written by surgeons during and after surgeries. These notes cover everything from the techniques, instruments used, any issues with the surgical procedure and post-surgical care for the patient. This information is a treasure trove for researchers because they can study it to understand how surgeries go, what works best, and how certain treatments affect patients.

By looking closely at these notes, researchers can find patterns and trends, helping them in understanding what makes surgeries successful and identify the best ways to perform them. This information is crucial for creating guidelines based on solid evidence. Also, these surgical notes are a goldmine for looking back at past surgeries to see how they have affected patients in the long run.

The real power for research comes when we combine these surgical notes within the Electronic Medical Records (EMR) and research databases. This makes it easy to collect information systematically, making it simpler for researchers to study a large number of cases. Unfortunately, not many people have paid attention to this idea for a long time, leading to big gaps in the data collection.

To address this issue, we aim to create a database that collects information from surgical notes effortlessly. This includes details about how surgeons are trained and how they progress. It's important to make sure that doctors work aligns with research - which is the best way to address data collection issues. This data can also help record different technical aspects of surgery and different surgeons' learning curve, making it easier to compare and improve training. Thus, we aim to standardise notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy.

The present study aims to model integration of clinical workflow data from Electronic Medical Records (EMR) to a research database using REDCap platform to enhance Prostate Cancer (PCa) research.

The objectives of the Victorian Robotic-assisted Radical Prostatectomy database are:

1. Collect functional outcomes from the PROMs, using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire at baseline (pre-surgery), 4 weeks, 6 months, 12 months, 24 months and 36 months post-surgery.
2. Gather detailed insights into surgical measures in terms of demographics, operative and post-operative characteristics.

   1. Operative characteristics will include: Protein-Specific Antigen (PSA) at surgery, surgery Gleason score, International Society of Urological Pathologists (ISUP) grade group, pathological T score, scans at surgery, amount of blood loss, operation duration, type of anesthesia, survival status, mortality, surgical margins and pain score.
   2. Post-operative characteristics will include: length of hospital stay, duration of catheter use, complications (if any) and reasons of readmission (if any).
3. Collect the oncological measures in terms of biochemical recurrence and margin status.
4. Track the progress of surgeons learning curve by comparing the surgeons' training data with Patient Reported Outcome Measures (PROM).

Males who are diagnosed with localized Prostate cancer

National Robotics-Assisted Radical Prostatectomy Database

National Robotics Radical Prostatectomy Database: Exploring Learning Curves and Long Term Surgical, Oncological and Patient Reported Outcomes

* Patient data will only be transferred and analysed in a coded form by mentioned investigators.
* Transferring patient data will require host organisation's formal approval
* Individual patients will not be identifiable from the presented or published material.
* The institution and the researcher must comply with all relevant laws and standards in relation to the use of the material.
* The institution and researcher must not use the material for any purpose other than the specified research or other purposes expressly permitted under the terms of the Agreement.
* Data linkage across sites will be set up when necessary. Once linkage has been completed, identifiers will be removed from the data to be used in the research, unless consent has been given for its identifiable use.

Standardize notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy.

The first set of outcome variables will be the functional outcomes from the PROMs, using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire

The second set of outcome variables will gather detailed insights into surgical measures in In terms of operative and post-operative characteristics.

The third set of outcome variables will collect the oncological measures in terms of Biochemical re-occurrence and margin status.

Peter MacCallum Cancer Centre, Australia

Epworth Healthcare

St Vincent's Hospital

Austin Health

Melbourne Health

Professor

Symptoms and General Pathology

Digestive System Diseases

Behaviors and Mental Disorders

Rare Diseases

Inflammation

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Quality of Life

Stomach Cancer

Acute Graft Versus Host Disease

Minimally invasive surgery revolutionized the field of gastric cancer surgery. The surgical robot was introduced to alleviate the difficulty of laparoscopic surgery. Although many studies have reported successful outcomes for robotic surgery, there is no multicenter prospective analysis regarding the advantage of the robotic gastrectomy. The aim of this study is to analyze the surgical outcomes of the robotic gastrectomy focusing on the learning curve, cost-effectiveness, quality of life, and acute-inflammatory reaction in comparison with laparoscopic gastrectomy.

Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer

Yonsei University

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Pancreatic Diseases

Pancreatic Cancer

EUS with the navigation system first on, then off

EUS with the navigation system first off, then on

Incorporation of the EUS navigation system to the EUS scope

EUS navigation system

Armelle TAKEDA, PhD

Leonardo SOSA VALENCIA, MD

The implementation of Echo-endoscopy (or EUS for: Endoscopic UltraSound) is limited by the difficulty of obtaining quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Indeed, both cognitive and technical skills are required for endoscopic manipulation and image interpretation, as well as a thorough knowledge of intra-abdominal anatomy. The "EUS-GPS" system aims to assist the operator in understanding the orientation and location of the probe tip within the patient. For that, a Global Positioning System (GPS) for EUS procedures is intraoperatively provided, using a 3D-based model based on recorded preoperative data.

In this clinical investigation, the EUS GPS system is intended to help EUS operators to correctly navigate towards the pancreatic gland, perform a comprehensive assessment of the area of interest, and aid in the detection and identification of lesions.

Since its emergence in the 1980s, endoscopic ultrasound (EUS) is considered as one of the most accurate tools for the evaluation of the pancreatic gland and other gastrointestinal (GI) disorders. Despite its utility, the practice of EUS is still far from being part of every endoscopy suite due to its high set-up cost and the relative scarcity of credentialed experts. EUS implementation worldwide has been limited by the difficulty of achieving quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Both cognitive and technical competencies are required for endoscopic manipulation and image interpretation, as well as extensive knowledge of intraabdominal anatomy.

The aim of the APEUS (Augmented Pancreatic Endoscopic UltraSound) project is to overcome these two main difficulties by providing a Global Positioning System (GPS)-like intraoperative navigation for EUS procedures, using a 3D-based model on registered preoperative data. The hypothesis is that, thanks to this tool, the procedures time would be shortened, and the pancreas and its lesions would be completely imaged. This would reduce the demand for experts guiding trainees and shorten the EUS learning curve.

This first-in-human clinical study will enable the assessment of safety and qualitative performance of the EUS-GPS solution. The primary objective is to evaluate the EUS navigation system's procedure duration compared to standard procedure times (patient group with the EUS-GPS system vs control group without).

First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study

Collect of peroperative duration for registration, insertion, navigation to cardia, navigation from the cardia to the pancreas, pancreas examination, therapeutic step and overall duration of the procedure (quantitative). Results will be compared between cases with (Groups EUS-NS) and without (Group EUS alone) use of the navigation system

Rate of intraoperative undesirable events and of any event related to the tested system (probe breaking, software crashing, etc.)

Collect of peroperative duration for registration, insertion, navigation to cardia, navigation from the cardia to the pancreas, pancreas examination, therapeutic step and overall duration of the procedure (quantitative). Results will be compared between cases with use of the navigation system first (Subgroup EUS-NS +) or in a second time (Subgroup EUS-NS -)

Questionnaire to assess the ease-of-use (integration in the standard-of-care workflow) of the EUS navigation system, filled by the EUS endoscopist (qualitative).

Questionnaire to assess the stressfulness of the EUS navigation system, filled by the EUS endoscopist (qualitative).

Collect adverse events, adverse device effects and device deficiencies during the procedure and up to 1 month after the EUS

A complete video recording of the procedure (endoscopic camera, ultrasound probe, pre-operative data real-time display and external camera) will be performed to assess the precision of the registration, using as anatomical points landmarks detectable in both CT and US images

Videos of the EUS procedure for further use in Artificial Intelligence-driven EUS research projects will be collected if the patient specifically consents to it. Recorded material will include the electromagnetic (EM) coordinates provided by the sensor. EUS video data associated with EM coordinates will be used to build databases for AI-driven EUS research projects

Questionnaire to evaluate the ergonomics and technological readiness, filled by the EUS endoscopist (qualitative).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prostatectomies Using Einstein Vision® 3D	NCT02991794	Prostate Carcin...	EinsteinVision ...	18 Years -	Aesculap AG
National Robotics-Assisted Radical Prostatectomy Database	NCT06279260	Database Prostate Cancer Robotic-assiste... Surgical Outcom... Oncological Out... Patient Reporte... Learning Curve		16 Years - 90 Years	Melbourne Health
Prostatectomies Using Einstein Vision® 3D	NCT02991794	Prostate Carcin...	EinsteinVision ...	18 Years -	Aesculap AG
Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer	NCT01309256	Gastric Cancer		20 Years -	Yonsei University
First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study	NCT05515705	Pancreatic Dise...	EUS navigation ...	18 Years -	IHU Strasbourg

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