Multicentric Study Comparing Carcinological and Functional Results of Surgery

Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502723

Acronym

PROPENLAP

Enrollment

1440

Registered

2007-07-18

Start date

2007-12-31

Completion date

2012-07-31

Last updated

2012-07-30

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

Conditions

Cancer of the PROSTATE

Keywords

Retropubic Prostatectomy, Surgical Procedures, Laparoscopic

Brief summary

National multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.

Detailed description

The aim of this study is to show that radical prostatectomy by laparoscopic way could obtain carcinological results not lower than theses with radical retropubic surgery.

Interventions

PROCEDURERadical retropubic prostatectomy

Radical retropubic prostatectomy

PROCEDURERadical laparoscopy prostatectomy

Radical laparoscopy prostatectomy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Male, old patient of less than 70 years, * having a prostate cancer proven histologically, requiring a radical prostatectomy. * Clinical stage T1c and rate of PSA (with 20 ng/ml). * Osseous scintiscanning and abdomen-pelvic scanner negative. * Patient informed of the study and its participation. * Patient affiliated to a social security system.

Exclusion criteria

* Contra-indication with the surgery or the anaesthesia. * Antecedent of prostate resection or adenomectomy. * Antecedent of inguinal hernia treatment. * Antecedent of deep venous thrombosis of the lower limbs or pulmonary embolism * Patient privatized of freedom.

Design outcomes

Primary

Measure	Time frame
laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.	during the study

Secondary

Measure	Time frame
Carcinological (percentage of positive surgical margins, percentage of capsular crossing).	after the surgical
Functional (urinary continence, sexuality, quality of life)	at 2 years
per and post operational morbidity	during the 36 months
economic	duration and cost of hospitalization

Countries

France

Contacts

Primary ContactClaude ABBOU, PU-PH

claude.abbou@hmn.aphp.fr33 (0)1.49.81.25.51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026