Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12618000597291
Ethics application status
Approved
Date submitted
13/03/2018
Date registered
18/04/2018
Date last updated
11/02/2021
Date data sharing statement initially provided
21/03/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Does placement of a pelvic drain tube after robot-assisted radical prostatectomy make a difference? A surgical trial of 320 men.
Query!
Scientific title
A prospective randomised trial comparing lymphocele rate in 320 men after randomisation to pelvic drain versus no pelvic drain during robot-assisted radical prostatectomy.
Query!
Secondary ID [1]
294332
0
None
Query!
Universal Trial Number (UTN)
U1111-1210-8992
Query!
Trial acronym
POPDART
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Robot-assisted Radical Prostatectomy
307050
0
Query!
Prostate Cancer
307165
0
Query!
Condition category
Condition code
Surgery
306160
306160
0
0
Query!
Surgical techniques
Query!
Cancer
306280
306280
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The study will compare the placement of pelvic drain versus no pelvic drain after robot-assisted radical prostatectomy (RARP). There is a lack of high level evidence for or against pelvic drain in this setting and hence both of these practices are currently routinely used and are considered standard of care.
All patients undergoing RARP for prostate cancer will be offered recruitment into this trial. Written and verbal information will be provided to patients prior to obtaining informed consent.
The intervention (drain or no drain) will be implemented at the end of the RARP operation. The urological surgeon will be responsible for the safe placement of drain (or no drain). The drain is made of plastic and is placed in the pelvis adjacent to the surgical bed and urethrovesical anastomosis. A bellows (200ml capacity) and bag (700ml capacity) are attached to the drain extra-corporeally to form a closed circuit. Duration of placement typically ranges from 12 to 36 hours.
Query!
Intervention code [1]
300639
0
Treatment: Devices
Query!
Comparator / control treatment
No control group. Both arms are considered current standard of care. For the purposes of this study, we will consider the drain group as the comparator.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
305173
0
Pelvic lymphocele rate confirmed on CT
Query!
Assessment method [1]
305173
0
Query!
Timepoint [1]
305173
0
Post-operative day 7-10 (only 1 CT is performed)
Query!
Secondary outcome [1]
344394
0
Length of stay. This data extracted from data linkage to electronic medical records.
Query!
Assessment method [1]
344394
0
Query!
Timepoint [1]
344394
0
On discharge from hospital
Query!
Secondary outcome [2]
344395
0
Post-operative pain using a visual analogue scale
Query!
Assessment method [2]
344395
0
Query!
Timepoint [2]
344395
0
Day 1 post-operatively and on discharge
Query!
Secondary outcome [3]
344396
0
Need for further intervention (percutaneous or open) via data linkage to electronic medical records.
Query!
Assessment method [3]
344396
0
Query!
Timepoint [3]
344396
0
This data will be extracted within 6 months of discharge.
Query!
Secondary outcome [4]
344397
0
Urine leak rate (assessed either by drain fluid Cr or CT)
Drain Fluid Cr is used if drain fluid output per 24hours is higher than expected. There is no minimum amount - it is decided at surgeon's discretion.
CT is used based on routine CT on day 7-10 post-operatively.
Query!
Assessment method [4]
344397
0
Query!
Timepoint [4]
344397
0
Drain fluid creatinine measurement on day 1 or day 2, OR CT image day 7-10
Query!
Secondary outcome [5]
344399
0
30-day re-admission rate data linked to medical records
Query!
Assessment method [5]
344399
0
Query!
Timepoint [5]
344399
0
Up to 30 days post intervention
Query!
Secondary outcome [6]
344726
0
Intra-ocular blood pressure measured using hand-held tonometer
Query!
Assessment method [6]
344726
0
Query!
Timepoint [6]
344726
0
Every 60 minutes from intubation to end of surgery
Query!
Secondary outcome [7]
344727
0
Intra-operative blood pressure using automatic blood pressure cuff
Query!
Assessment method [7]
344727
0
Query!
Timepoint [7]
344727
0
Every 60 minutes from intubation to end of surgery
Query!
Secondary outcome [8]
344728
0
Total operative time (Manual time marked at start and end of surgery)
Query!
Assessment method [8]
344728
0
Query!
Timepoint [8]
344728
0
End of surgery
Query!
Eligibility
Key inclusion criteria
Any patient undergoing robot-assisted radical prostatectomy for prostate cancer
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Prior pelvic radiotherapy
Prior pelvic surgery
Distant metastatic prostate cancer
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Withdrawn
Query!
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Query!
Other reasons
Recruitment of participants did not occur
Query!
Date of first participant enrolment
Anticipated
1/04/2019
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
31/08/2020
Query!
Actual
Query!
Date of last data collection
Anticipated
6/01/2020
Query!
Actual
Query!
Sample size
Target
320
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
10383
0
Nepean Hospital - Kingswood
Query!
Recruitment hospital [2]
10384
0
Macquarie University Hospital - Macquarie Park
Query!
Recruitment postcode(s) [1]
22062
0
2747 - Kingswood
Query!
Recruitment postcode(s) [2]
22063
0
2109 - Macquarie Park
Query!
Funding & Sponsors
Funding source category [1]
299219
0
Other Collaborative groups
Query!
Name [1]
299219
0
Nepean Urology Research Group
Query!
Address [1]
299219
0
Nepean Hospital
Derby Street
Kingswood, NSW 2747
Query!
Country [1]
299219
0
Australia
Query!
Primary sponsor type
Other Collaborative groups
Query!
Name
Nepean Urology Research Group
Query!
Address
Nepean Hospital
Derby Street
Kingswood, NSW 2747
Query!
Country
Australia
Query!
Secondary sponsor category [1]
298483
0
None
Query!
Name [1]
298483
0
Query!
Address [1]
298483
0
Query!
Country [1]
298483
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
299905
0
Nepean HREA Committee
Query!
Ethics committee address [1]
299905
0
Nepean Hospital
Derby Street
Kingswood NSW 2747
Query!
Ethics committee country [1]
299905
0
Australia
Query!
Date submitted for ethics approval [1]
299905
0
16/04/2018
Query!
Approval date [1]
299905
0
17/01/2019
Query!
Ethics approval number [1]
299905
0
HREC/18/NEPEAN/75
Query!
Summary
Brief summary
The purpose of this study is to evaluate the efficacy of pelvic drain versus no pelvic drain on lymphocele rate in men undergoing robot-assisted radical prostatectomy for prostate cancer.
Who is it for?
You may be eligible for this study if you are aged 18 years or above and are undergoing robot-assisted radical prostatectomy for prostate cancer.
Study details
The study will compare the placement of pelvic drain versus no pelvic drain after robot-assisted radical prostatectomy (RARP). Patients will be allocated to one of two treatments based on chance alone. The intervention (drain or no drain) will be implemented at the end of the RARP operation. The urological surgeon will be responsible for the safe placement of drain (or no drain). The drain is made of plastic and is placed in the pelvis adjacent to the surgical bed. Duration of placement typically ranges from 12 to 36 hours.
It is hoped that this study will provide high quality evidence to inform management for Australian and international urologists.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
81942
0
Dr Isaac Thangasamy
Query!
Address
81942
0
PO BOX 486
Pennant Hills
NSW 1715
Query!
Country
81942
0
Australia
Query!
Phone
81942
0
+61400994387
Query!
Fax
81942
0
Query!
Email
81942
0
[email protected]
Query!
Contact person for public queries
Name
81943
0
Dr Isaac Thangasamy
Query!
Address
81943
0
PO BOX 486
Pennant Hills
NSW 1715
Query!
Country
81943
0
Australia
Query!
Phone
81943
0
+61400994387
Query!
Fax
81943
0
Query!
Email
81943
0
[email protected]
Query!
Contact person for scientific queries
Name
81944
0
Dr Isaac Thangasamy
Query!
Address
81944
0
PO BOX 486
Pennant Hills
NSW 1715
Query!
Country
81944
0
Australia
Query!
Phone
81944
0
+61400994387
Query!
Fax
81944
0
Query!
Email
81944
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Privacy compliance
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF