Trial Title:
National Robotics-Assisted Radical Prostatectomy Database
NCT ID:
NCT06279260
Condition:
Database
Prostate Cancer
Robotic-assisted Radical Prostatectomy
Surgical Outcomes
Oncological Outcomes
Patient Reported Outcome Measures
Learning Curve
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
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.
Detailed 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 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.
Criteria for eligibility:
Study pop:
The database will entail recruitment of retrospective and prospective patient cohorts to
collect and analyse data. Retrospective data from the last five years will be obtained
from the medical records. Prospective data will be collected from each participating
site.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
Male
Gender based:
Yes
Gender description:
Males who are diagnosed with localized Prostate cancer
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ballarat Health
Address:
City:
Ballarat
Zip:
3350
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Barwon health
Address:
City:
Geelong
Zip:
3220
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
George Mirmilstein
Facility:
Name:
Austin Healthcare
Address:
City:
Melbourne
Zip:
2084
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Damien Bolton
Facility:
Name:
E.J Whitten Prostate Cancer Centre, Epworth Healthcare
Address:
City:
Melbourne
Zip:
3002
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Dixon Woon
Facility:
Name:
St. Vincent's Private Hospital
Address:
City:
Melbourne
Zip:
3002
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Lih-Ming Wong
Facility:
Name:
Western Heath
Address:
City:
Melbourne
Zip:
3011
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Niall Corcoran
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3050
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Marlon Perara
Facility:
Name:
Royal Melbourne Hospital
Address:
City:
Melbourne
Zip:
3050
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Nathan Lawrentschuk
Start date:
July 1, 2024
Completion date:
December 2050
Lead sponsor:
Agency:
Melbourne Health
Agency class:
Other
Collaborator:
Agency:
Peter MacCallum Cancer Centre, Australia
Agency class:
Other
Collaborator:
Agency:
Epworth Healthcare
Agency class:
Other
Collaborator:
Agency:
St Vincent's Hospital
Agency class:
Other
Collaborator:
Agency:
Austin Health
Agency class:
Other
Collaborator:
Agency:
Barwon Health
Agency class:
Other
Collaborator:
Agency:
Ballarat Health Services
Agency class:
Other
Collaborator:
Agency:
Western Health, Australia
Agency class:
Other
Source:
Melbourne Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06279260
