Laparoscopic vs Robotic-Assisted Radical Prostatectomy (LAP-01)

University of Leipzig

Status

Completed

Conditions

Prostate Cancer

Treatments

Procedure: Prostatectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03682146

110462 (Other Grant/Funding Number)

LAP-01

Details and patient eligibility

About

This randomized trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy (RP).

Purpose: The LAP-01 trial compares outcomes between RARP and LRP.

Full description

LAP-01 is the first multicenter, prospective randomized, patient-blinded controlled trial comparing robotic-assisted and conventional laparoscopic radical prostatectomy.

The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures.

The primary outcome is the assessment of time to continence restoration at 3 months. This is evaluated by an assessment of a pad diary completed daily by each patient from the time of catheter removal until restoration of continence. Secondary endpoints include continence and erectile function, as well as quality of life (EORTC-QLQ-C30, EORTC-QLQ-PR25), patient satisfaction and Hospital Anxiety and Depression Scale (HADS) at 1, 3, 6 and 12 months after surgery in addition to oncological outcomes up to 3 years follow-up.

With 782 enrolled patients it is the largest trial carried out till date on this topic.

Enrollment

782 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Histological verified prostate carcinoma (first diagnosis)
Indication for primary curative radical prostatectomy
Age ≤ 75 years
Patient agrees to randomisation
Patient is able to fill in the questionnaires on his own
Patient is willing to provide written informed consent

Exclusion Criteria:

Insufficient knowledge of German
Severe cognitive impairment
Obesity (BMI > 35)
Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind)
Tumor stage: T4
Previous malignancy (≤ 3 years before trial participation)
Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial
Patient is immuno-compromised
History of intermittent urinary self-catheterization within the last year
Psychological disorders (dementia, chronic depression, psychosis)
Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy
Patients with chronic urinary infection
Dialysis patients
Lacking willingness for data storage and handling in the frame of the trial protocol/aims