Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01578356

Enrollment

100

Registered

2012-04-16

Start date

2009-01-01

Completion date

2012-10-31

Last updated

2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer

Brief summary

For primary surgical treatment of prostate cancer the investigators compare the classic open surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery (RALP). Oncological results are obtained at standard follow-up consultations through Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Currently the investigators perform all of their prostatectomies in a robot-assisted manner. For results of the open surgery the investigators send questionnaires to patients who had the operation in the past.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* prostate cancer * radical retropubic prostatectomy or * robot-assisted laparoscopic surgery

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Biochemical recurrence at follow-up.	3 months after prostatectomy	PSA measurement in the serum should not be \> or = 0,20 ng/ml.
Biochemical recurrence at follow-up	6 months after prostatectomy	PSA measurement in the serum should not be \> or = 0,20 ng/ml.

Secondary

Measure	Time frame	Description
Functional assessment concerning continence.	after 1, 3, 12 and 24 months	Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.
Functional assessment concerning potency.	after 1, 3, 12 and 24 months	Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.
Functional assessment concerning quality of life.	after 1, 3, 12 and 24 months	Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.

Countries

Belgium

Outcome results