Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279260
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-02-19
Brief Title:
National Robotics-Assisted Radical Prostatectomy Database
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
Official Title:
National Robotics-Assisted Radical Prostatectomy Database Exploring Learning Curves and Long Term Surgical Oncological and Patient Reported Outcome Measures PROMS
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RASOR
Brief Summary:
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
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
Detailed Description:
Radical Prostatectomy RP is the only surgical option for resectable PCA with evidenced benefit for overall survival 56 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 7891011 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 13416 AUD per minute which costs the patient and the hospital 30 58848 AUD per case The health industry average costs for a RARP procedure is 32199 AUD per case A transition point of 65 cases at the industry average will cost up to 2092935 AUD to consistent primary outcomes for patients 13 Surgeons 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 12 vs 44 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 prostatectomy 44 was larger than that for public patients 28 16 There are fewer robots in the public sector compared to private hospitals hence public patients are offered alternate approaches
A barrier to the uptake of robotic-assisted surgery RAS continues to be the perceived high costs A lack of detailed costing information has made it difficult for public hospitals in particular to determine whether use of the technology is justified 17 This inconsistency in approach and lack of detail makes it difficult for local hospital administrators health ministries and governing bodies to determine whether the costs of the technology are reasonable and worth the ongoing investment and has the potential to impact on future strategic decision-making
It is notable that robust evidence substantiating the advantages of robotic surgery from high volume centres is currently insufficient The acquisition of high-quality evidence pertaining to surgical techniques poses a formidable challenge 18 Robust investigations characterized by substantial scale and comparativeness are imperative for a comprehensive assessment of the surgical oncological and Patient reported outcomes along with learning curves of surgeons associated with RARP
There is an imperative need for the establishment of a population-based database that systematically captures a comprehensive array of surgical operatives learning curves of surgeons and the patient-reported quality of life measures PROM A structured database holds the potential to provide a standardized framework enabling robust comparative analyses trend identification and the formulation of evidence-based guidelines for the individualized management of prostate cancer
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 13416 AUD per minute which costs the patient and the hospital 30 58848 AUD per case The health industry average costs for a RARP procedure is 32199 AUD per case A transition point of 65 cases at the industry average will cost up to 2092935 AUD to consistent primary outcomes for patients 13 Surgeons 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 12 vs 44 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 prostatectomy 44 was larger than that for public patients 28 16 There are fewer robots in the public sector compared to private hospitals hence public patients are offered alternate approaches
A barrier to the uptake of robotic-assisted surgery RAS continues to be the perceived high costs A lack of detailed costing information has made it difficult for public hospitals in particular to determine whether use of the technology is justified 17 This inconsistency in approach and lack of detail makes it difficult for local hospital administrators health ministries and governing bodies to determine whether the costs of the technology are reasonable and worth the ongoing investment and has the potential to impact on future strategic decision-making
It is notable that robust evidence substantiating the advantages of robotic surgery from high volume centres is currently insufficient The acquisition of high-quality evidence pertaining to surgical techniques poses a formidable challenge 18 Robust investigations characterized by substantial scale and comparativeness are imperative for a comprehensive assessment of the surgical oncological and Patient reported outcomes along with learning curves of surgeons associated with RARP
There is an imperative need for the establishment of a population-based database that systematically captures a comprehensive array of surgical operatives learning curves of surgeons and the patient-reported quality of life measures PROM A structured database holds the potential to provide a standardized framework enabling robust comparative analyses trend identification and the formulation of evidence-based guidelines for the individualized management of prostate cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None