Patient outcomes after open and minimally invasive surgery for prostate cancer

Not Applicable

Completed

• Conditions: ocalised Prostate Cancer; Localised Prostate Cancer; Cancer - Prostate; Surgery - Surgical techniques

• Registration Number: ACTRN12611000593932
• Lead Sponsor: Mari Botti

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 450

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.

Exclusion Criteria

Patients who are unable to provide informed consent to participate.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional and Psychosocial Status using the following:<br>SF36v2, HADS, AQoL-8D, Prostate Cancer Quality of Life Scale.[baseline, 7 days, 4 weeks, 3 months, 6 months, 12 months, 18 months, 24 months];Sexual function using the following:<br>SHIM, EPIC (sexual), Prostate Cancer Quality of Life Scale (sexual intimacy)[baseline, 7 days, 4 weeks, 3 months, 6 months, 12 months, 18 months, 24 months];Urinary function using the following:<br>SHIM, EPIC (urinary), Prostate Cancer Quality of Life Scale (urinary control)[baseline, 7 days, 4 weeks, 3 months, 6 months, 12 months, 18 months, 24 months]

Secondary Outcome Measures

Name	Time	Method
Pain Intensity and quality using the American Pain Society Patient Outcome Questionnaire (APSPOQ), McGill Pain Questionnaire short form (MPQSF)[postoperative, 7 days, 4 weeks];wound healing by assessing wound apposition, infection and time to removal of sutures.[postoperative, 7 days, 4 weeks];Length of hospital stay measured from Day 1 (where Day 0 is day of surgery) to day of discharge from hospital inclusive.[At time of discharge.];decisional regret measured using the Decisional Regret Scale and the Prostate Cancer Quality of Life Scale (regret)[4 weeks, 3 months, 6 months, 12 months, 18 months, 24 months]