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3D Versus Robot Assisted Laparoscopic Prostatectomy.

NCT ID: NCT03550040

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2022-07-30

Brief Summary

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A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures.

Detailed Description

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The direct and indirect costs, functional and oncologic results of robot assisted radical prostatectomy (RALP) are compared to those of 3D laparoscopic radical prostatectomy. The hypothesis of the study is that the functional and oncologic results of the two operative methods are equal, but the direct costs of RAPL are significantly higher. A randomized, prospective non-inferiority study will will enroll 280 patients randomized 1:1 to both operative approaches to test this hypothesis. The primary functional outcome measure is the proportion of patients with complete urinary continence (no protective pad use) at 12 months post operatively. Secondary functional outcome measure is the preservation erectile function at 12 months post operatively. Oncologic outcome measures are the proportion of patients with undetectable post operative prostate specific antigen levels and positive surgical margins at pathological examination. The direct and indirect costs of both operative approaches are recorded.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robot assisted prostatectomy.

Intervention: radical prostatectomy

Group Type ACTIVE_COMPARATOR

Radical prostatectomy

Intervention Type PROCEDURE

Surgical removal of the prostate

3D laparoscopic prostatectomy

Intervention: radical prostatectomy

Group Type EXPERIMENTAL

Radical prostatectomy

Intervention Type PROCEDURE

Surgical removal of the prostate

Interventions

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Radical prostatectomy

Surgical removal of the prostate

Intervention Type PROCEDURE

Other Intervention Names

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Total prostatectomy

Eligibility Criteria

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Inclusion Criteria

* Localized prostate cancer undergoing radical prostatectomy
* Patient has to understand and be able to write and read Finnish language
* No prior head injury, dementia or Parkinson's disease
* No concomitant malignant illness
* Life expectancy of at least 10 years
* 35-74 years of age

Exclusion Criteria

* Locally advanced prostate cancer (T4)
* Suspicion or documented metastases (M1)
* Serum PSA \> 20 ng/ml
* Prior laparoscopic hernia surgery employing non resorbable mesh
* Prior pelvic irradiation or major surgery
* Prior malignant disease within prior 5 years excluding skin cancer (non-melanoma).
Minimum Eligible Age

34 Years

Maximum Eligible Age

74 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Seinajoki Central Hospital

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Antti Kaipia

Chief physician, department of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antti Kaipia, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

chief, dept of urology

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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18005

Identifier Type: -

Identifier Source: org_study_id