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Trial registered on ANZCTR


Registration number
ACTRN12618000597291p
Ethics application status
Submitted, not yet approved
Date submitted
13/03/2018
Date registered
18/04/2018
Date last updated
18/04/2018
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.
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.
Secondary ID [1] 294332 0
None
Universal Trial Number (UTN)
U1111-1210-8992
Trial acronym
POPDART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Robot-assisted Radical Prostatectomy 307050 0
Prostate Cancer 307165 0
Condition category
Condition code
Surgery 306160 306160 0 0
Surgical techniques
Cancer 306280 306280 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 300639 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 305173 0
Pelvic lymphocele rate confirmed on CT
Timepoint [1] 305173 0
Post-operative day 7-10 (only 1 CT is performed)
Secondary outcome [1] 344394 0
Length of stay. This data extracted from data linkage to electronic medical records.
Timepoint [1] 344394 0
On discharge from hospital
Secondary outcome [2] 344395 0
Post-operative pain using a visual analogue scale
Timepoint [2] 344395 0
Day 1 post-operatively and on discharge
Secondary outcome [3] 344396 0
Need for further intervention (percutaneous or open) via data linkage to electronic medical records.
Timepoint [3] 344396 0
This data will be extracted within 6 months of discharge.
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.
Timepoint [4] 344397 0
Drain fluid creatinine measurement on day 1 or day 2, OR CT image day 7-10
Secondary outcome [5] 344399 0
30-day re-admission rate data linked to medical records
Timepoint [5] 344399 0
Up to 30 days post intervention
Secondary outcome [6] 344726 0
Intra-ocular blood pressure measured using hand-held tonometer
Timepoint [6] 344726 0
Every 60 minutes from intubation to end of surgery
Secondary outcome [7] 344727 0
Intra-operative blood pressure using automatic blood pressure cuff
Timepoint [7] 344727 0
Every 60 minutes from intubation to end of surgery
Secondary outcome [8] 344728 0
Total operative time (Manual time marked at start and end of surgery)
Timepoint [8] 344728 0
End of surgery

Eligibility
Key inclusion criteria
Any patient undergoing robot-assisted radical prostatectomy for prostate cancer
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Prior pelvic radiotherapy
Prior pelvic surgery
Distant metastatic prostate cancer

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10383 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 10384 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 22062 0
2747 - Kingswood
Recruitment postcode(s) [2] 22063 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 299219 0
Other Collaborative groups
Name [1] 299219 0
Nepean Urology Research Group
Address [1] 299219 0
Nepean Hospital
Derby Street
Kingswood, NSW 2747
Country [1] 299219 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Nepean Urology Research Group
Address
Nepean Hospital
Derby Street
Kingswood, NSW 2747
Country
Australia
Secondary sponsor category [1] 298483 0
None
Name [1] 298483 0
Address [1] 298483 0
Country [1] 298483 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299905 0
Nepean HREA Committee
Ethics committee address [1] 299905 0
Nepean Hospital
Derby Street
Kingswood NSW 2747
Ethics committee country [1] 299905 0
Australia
Date submitted for ethics approval [1] 299905 0
16/04/2018
Approval date [1] 299905 0
Ethics approval number [1] 299905 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81942 0
Dr Isaac Thangasamy
Address 81942 0
PO BOX 486
Pennant Hills
NSW 1715
Country 81942 0
Australia
Phone 81942 0
+61400994387
Fax 81942 0
Email 81942 0
ithangasamy@gmail.com
Contact person for public queries
Name 81943 0
Dr Isaac Thangasamy
Address 81943 0
PO BOX 486
Pennant Hills
NSW 1715
Country 81943 0
Australia
Phone 81943 0
+61400994387
Fax 81943 0
Email 81943 0
ithangasamy@gmail.com
Contact person for scientific queries
Name 81944 0
Dr Isaac Thangasamy
Address 81944 0
PO BOX 486
Pennant Hills
NSW 1715
Country 81944 0
Australia
Phone 81944 0
+61400994387
Fax 81944 0
Email 81944 0
ithangasamy@gmail.com

No data has been provided for results reporting
Summary results
Not applicable