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Recruiting NCT06279260

National Robotics-Assisted Radical Prostatectomy Database

Conditions: Database Prostate Cancer Robotic-assisted Radical Prostatectomy Surgical Outcomes Oncological Outcomes Patient Reported Outcome Measures Learning Curve

Sponsor: Melbourne Health

trial.available_in: БГ
Overview
In Australia, nearly 70 men are diagnosed with Prostate cancer every day. Prostate removal (Radical Prostatectomy) is the proven treatment option to control cancer spread. Most of the prostate removal surgeries are done using robots. Robotic assisted prostate removal surgeries have been invented to minimise the risk of side effects post-surgery. Doctors prefer the robots over open surgery as there are benefits to patients (shorter hospital stays, lesser blood loss and better quality of life) and surgeons (better dexterity, improved field of vision and less pain). However, the cost of the robot outweighs the benefits at present and there is very less information concerning the long-term outcomes for patients. Studies conducted so far are small scale studies and the results from these studies cannot be generalized to the population at large in Australia. So, there is need for a largescale study that will look at the long-term outcomes and the factors that impact robotic surgeries across the metropolitan and rural hospital sectors. Hence, this comprehensive database has been setup to collaborate with major hospitals, across metropolitan and rural areas in Australia. Through this database, researchers will be able to explore the diagnostic pathway for Prostate cancer and understand the long-term benefits of robotic surgery through patient reported questionnaires. Outcomes from this database will also help compare the quality of care against other powerhouses of robotic surgery. Eventually, the database aims to standardize diagnostic pathways and clinical notes that are the same across different hospitals conducting robotic-assisted surgeries for Prostatectomy and improve care for prostate cancer patients across the country.
Description
Radical Prostatectomy (RP) is the only surgical option for resectable PCA with evidenced benefit for overall survival \[5,6\]. Robotic-Assisted Radical Prostatectomy (RARP) is an evolved RP represents a significant advancement in PCa treatment offering better field of vision \& dexterity for the surgeons \[7,8,9,10,11\] compared to other procedures such as Open Radical Prostatectomy (ORP) and Laparoscopic Radical prostatectomy (LRP). A meta-analysis \[12\] of Randomized Control Trials (RCT) and non-randomized studies reported that RARP and LRP were similar in terms of blood loss, catheter indwelling time, overall complication rate, overall positive surgical margin and biochemical recurrence rates. However, quantitative synthesis of non-randomized studies indicated that RARP was associated with better functional and oncological outcomes compared to LRP. Despite RARP holding promising benefits, it also presents some potential challenges such as: 1. Learning curve - Surgeons require significant training and experience to become proficient in using robotic systems. This learning curve can impact surgical outcomes, especially in less experienced hands. 2. Cost - The robotic systems and associated instruments are expensive, leading to higher upfront costs for hospitals. This can translate to higher costs for patients and healthcare systems. 3. Disparity between private and public sectors: availability of robotic surgery can be limited by geographic and economic factors, potentially leading to disparities in access to advanced surgical option. A retrospective audit of all RARP procedures performed at high volume centre in Australia highlighted, operating time costs for RARP is $134.16 AUD per minute which costs the patient and the hospital $30, 588.48 AUD per case. The health industry average costs for a RARP procedure is 32,199 AUD per case. A transition point of 65 cases at the industry average will cost up to $2,092,935 AUD to consistent primary outcomes for patients \[13\]. Surgeon's experience and efficiency become an important determinant of post RARP outcomes. Incorporating assessment protocols and intensive training programs might contribute to better post RARP outcomes \[14\]. Another Australian study \[15\] evaluated the ORP versus RARP outcomes at a high-volume centre. Results of the study indicated significantly lower mean Length of Stay (LOS) for RARP compared with ORP (1.2 vs 4.4 days) and a much higher readmission rate after ORP (19%) compared with RARP (2%). Though the study reported evidenced benefits, it also highlighted that case-mix funding model failed to adequately reimburse the public hospitals for RARP when compared with ORP despite efficient use of hospital resources in terms of hospital stay and reduction in costly readmissions. A massive inequality gap exists between the public and private sectors. A retrospective analysis of Victorian Cancer Registry data found proportion of private patients who underwent radical prosta
Who can participate
Inclusion Criteria: To be eligible to participate in this database, an individual must meet all of the following criteria: 1. Individuals who consent to participate, 2. within the age range of 18 to 90 years, 3. confirmed diagnosis of localized prostate cancer (PCa) 4. patients receiving medical attention at hospitals engaged in collaborative efforts with the designated database. Exclusion Criteria: 1. Participants are not eligible to take part in the database: 2. Individuals who have not undergone robotic surgery for prostatectomy or TP biopsy. , 3. without a diagnosis of prostate cancer or 4. who decline to provide consent for the collection of their health information 5. Under the age of 18 years.
Locations 1
Australia (1)
Ballarat Health
Ballarat , Victoria
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male only
Minimum age
18 Years
Maximum age
90 Years
Healthy volunteers
No
Start date
01.07.2024
Completion date
01.12.2050
Registry ID
NCT06279260
Source
anzctr
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