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
Trial registered on ANZCTR


Registration number
ACTRN12611000593932
Ethics application status
Approved
Date submitted
8/06/2011
Date registered
8/06/2011
Date last updated
5/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient outcomes after open and minimally invasive surgery for prostate cancer
Scientific title
Patient outcomes after open and minimally invasive surgery for prostate cancer
Secondary ID [1] 259916 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Localised Prostate Cancer 265523 0
Condition category
Condition code
Cancer 265680 265680 0 0
Prostate
Surgery 268181 268181 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patient outcomes after open radical prostatectomy for localised prostate cancer using repeated measures for 24 months after surgery.
Intervention code [1] 266733 0
Not applicable
Comparator / control treatment
Patient outcomes after robot assisted radical prostatectomy and laparoscopic prostatectmy for localised prostate cancer using repeated measures for 24 months after surgery.
Control group
Active

Outcomes
Primary outcome [1] 266455 0
Functional and Psychosocial Status using the following:
SF36v2, HADS, AQoL-8D, Prostate Cancer Quality of Life Scale.
Timepoint [1] 266455 0
baseline, 7 days, 4 weeks, 3 months, 6 months, 12 months, 18 months, 24 months
Primary outcome [2] 266456 0
Sexual function using the following:
SHIM, EPIC (sexual), Prostate Cancer Quality of Life Scale (sexual intimacy)
Timepoint [2] 266456 0
baseline, 7 days, 4 weeks, 3 months, 6 months, 12 months, 18 months, 24 months
Primary outcome [3] 266457 0
Urinary function using the following:
SHIM, EPIC (urinary), Prostate Cancer Quality of Life Scale (urinary control)
Timepoint [3] 266457 0
baseline, 7 days, 4 weeks, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary outcome [1] 273809 0
Pain Intensity and quality using the American Pain Society Patient Outcome Questionnaire (APSPOQ), McGill Pain Questionnaire short form (MPQSF)
Timepoint [1] 273809 0
postoperative, 7 days, 4 weeks
Secondary outcome [2] 273810 0
wound healing by assessing wound apposition, infection and time to removal of sutures.
Timepoint [2] 273810 0
postoperative, 7 days, 4 weeks
Secondary outcome [3] 273811 0
Length of hospital stay measured from Day 1 (where Day 0 is day of surgery) to day of discharge from hospital inclusive.
Timepoint [3] 273811 0
At time of discharge.
Secondary outcome [4] 273812 0
decisional regret measured using the Decisional Regret Scale and the Prostate Cancer Quality of Life Scale (regret)
Timepoint [4] 273812 0
4 weeks, 3 months, 6 months, 12 months, 18 months, 24 months

Eligibility
Key inclusion criteria
Patients undergoing Radical Retropubic Prostatectomy, Robot Assisted Radical Prostatectomy and Laparascopic Radical Prostatectomy for localised prostate cancer, admitted for elective surgery, over the age of 18 years and under the care of urology surgeons listed as Investigators.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unable to provide informed consent to participate.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
VIC
Recruitment postcode(s) [1] 4069 0
3144
Recruitment postcode(s) [2] 4070 0
3121

Funding & Sponsors
Funding source category [1] 264801 0
Charities/Societies/Foundations
Name [1] 264801 0
Prostate Cancer Foundation Australia
Address [1] 264801 0
Level 3
39-41 Chandos St
St Leonards NSW 2065
Country [1] 264801 0
Australia
Primary sponsor type
Individual
Name
Mari Botti
Address
School of Nursing and Midwifery
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Country
Australia
Secondary sponsor category [1] 266284 0
Other Collaborative groups
Name [1] 266284 0
Patient Outcomes after Prostate Surgery Investigators
Address [1] 266284 0
Epworth HealthCare
89 Bridge Road
Richmond Victoria 3121

Cabrini Health
183 Wattletree Road
Malvern Victoria 3144
Country [1] 266284 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269208 0
Deakin University Human Research and Ethics Committee
Ethics committee address [1] 269208 0
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Ethics committee country [1] 269208 0
Australia
Date submitted for ethics approval [1] 269208 0
Approval date [1] 269208 0
04/05/2009
Ethics approval number [1] 269208 0
EC34-2009
Ethics committee name [2] 269209 0
Epworth Healthcare Human Research Ethics Committee
Ethics committee address [2] 269209 0
Epworth HealthCare
89 Bridge Road
Richmond Victoria 3121
Ethics committee country [2] 269209 0
Australia
Date submitted for ethics approval [2] 269209 0
Approval date [2] 269209 0
05/11/2008
Ethics approval number [2] 269209 0
42808
Ethics committee name [3] 269210 0
Cabrini Human Research Ethics Committee
Ethics committee address [3] 269210 0
Cabrini Health
183 Wattletree Road
Malvern Victoria 3144
Ethics committee country [3] 269210 0
Australia
Date submitted for ethics approval [3] 269210 0
Approval date [3] 269210 0
07/08/2006
Ethics approval number [3] 269210 0
02-10-07-06

Summary
Brief summary
The aim of this project is to evaluate and compare patients' physiological, functional and psychosocial recovery after three forms of radical prostatectomy surgery (open radical retropubic prostatectomy and two approaches to minimally invasive surgery: robotic-assisted radical prostatectomy and laparoscopic radical prostatectomy) for localised prostatic cancer.
Recovery will be evaluated using repeated measures during three key transitions: acute (time in hospital), intermediate (7 days and 4 weeks after surgery) and long term (3 months, 6 months, 12, 18 and 24 months post surgery). The three cohorts of patients will be matched for age and prostate cancer-related criteria. Baseline preoperative assessment of patients will include: demographic characteristics, functional status including urinary and sexual function, and psychosocial status. Recovery variables will include repeated measures of: pain intensity and quality, wound healing, functional and psychosocial status.
Trial website
Trial related presentations / publications
Study protocol
http://hdl.handle.net/10536/DRO/DU:30108464
Public notes

Contacts
Principal investigator
Name 32437 0
Prof Mari Botti
Address 32437 0
Deakin University Geelong,
Faculty of Health
Victoria 3220
Country 32437 0
Australia
Phone 32437 0
+61 3 94266565
Fax 32437 0
Email 32437 0
marib@deakin.edu.au
Contact person for public queries
Name 15684 0
Prof Professor Mari Botti
Address 15684 0
Deakin University
Faculty of Health
221 Burwood Highway
Burwood Victoria 3125
Country 15684 0
Australia
Phone 15684 0
61 3 94266565
Fax 15684 0
Email 15684 0
marib@deakin.edu.au
Contact person for scientific queries
Name 6612 0
Prof Professor Mari Botti
Address 6612 0
Deakin University
Faculty of Health
221 Burwood Highway
Burwood Victoria 3125
Country 6612 0
Australia
Phone 6612 0
61 3 94266565
Fax 6612 0
Email 6612 0
marib@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary