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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03682146
Other study ID # LAP-01
Secondary ID 110462
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date December 2021

Study information

Verified date September 2020
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 782
Est. completion date December 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Prostatectomy
Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy

Locations

Country Name City State
Germany Klinikum Dortmund Dortmund
Germany Universitätsklinikum Düsseldorf Düsseldorf
Germany University Hospital Heidelberg Heidelberg
Germany University of Leipzig Leipzig

Sponsors (4)

Lead Sponsor Collaborator
University of Leipzig Heinrich-Heine University, Duesseldorf, Klinikum Dortmund, University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early Continence The primary outcome is continence recovery at 3 months based on the patient's pad diary; RARP vs. LRP 3 months after removal of the urinary catheter
Secondary Continence Continence (pad use/day) 1, 3, 6, 12 months postoperative
Secondary Continence Continence (ICIQ-SF scores) 1, 3, 6, 12 months postoperative
Secondary Erectile function Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection 1, 3, 6, 12 months postoperative
Secondary Health-related quality of life of patients Health-related quality of life questionnaire (EORTC QLQ-C30). Raw scores are linearly transformed into a 0-100 point scale. High global health status and functioning scores indicate good QoL, whereas elevated symptom scores represent a high level of symptomology and therefore impaired QoL. 1, 3, 6, 12 months postoperative
Secondary Prostate-specific quality of life of patients Prostate-specific quality of life questionnaire (EORTC QLQ-PR25). Raw scores are linearly transformed into a 0-100 point scale. High functioning scores indicate good QoL, whereas elevated symptom scores represent a high level of symptomology and therefore impaired QoL. 1, 3, 6, 12 months postoperative
Secondary Anxiety and depression assessment The Hospital Anxiety and Depression Scales (HADS-D) 1, 3, 6, 12 months postoperative
Secondary Patient satisfaction Patient satisfaction is measured on a 5-point scale ranging from highly dissatisfied to highly satisfied. Additionally, patients are asked if they would in hindsight make a decision for or against the surgery and if they would advise a friend to undergo surgery under the same circumstances. 1, 3, 6, 12 months postoperative
Secondary PSA (prostate-specific antigen) PSA (prostate-specific antigen) 1, 3, 6, 12, 24, 36 months postoperative
Secondary Rate of relapse and metastases Relapse and metastases 1, 3, 6, 12, 24, 36 months postoperative
Secondary Rate of patients with further anti-cancer therapy Further anti-cancer therapy 1, 3, 6, 12, 24, 36 months postoperative
Secondary Time of surgery time of surgery measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console
Secondary Tumor Resection Tumor Resection during surgery
Secondary Intra-operative parameters Rate of Complications during surgery
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