Laparoscopic and Robot-Assisted Radical Prostatectomy - a Comparative Study - Clinical Trial for Prostate Cancer | NCT03682146

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Prostatectomy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring DaVinci, Robot Assisted, Prostatectomy, Laparoscopy, Continence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Exclusion Criteria:

Strong cognitive disturbance
Patients BMI > 35
Current attendant disease as: cirrhosis of the liver, relapse
TNM-System: T4
Within the last three years: Previous malignant tumor, Neoadjuvant therapy
Patient who are immunosuppressed
Patient has a history of intermitted self-catheterization (one year prior to the start of the trial)
Disease of dementia, chronic depression or psychosis
chronic urinary tract infection ( five episodes of antibiotic intakes)
dialysis-dependent patients
absent attendance for memorization and report of disease data in context to the study
If the patient had the following treatments within the last three months: Surgery of the Sigmoid colon, hemorrhoidectomy, transurethral needle ablation (TUNA), osteosynthesis in pelvic area, salvage prostatectomy

Sites / Locations

Klinikum DortmundRecruiting
Universitätsklinikum DüsseldorfRecruiting
University Hospital HeidelbergRecruiting
Universitätsklinikum LeipzigRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

R-LRPE

LRPE

Arm Description

robot-assisted laparoscopic prostatectomy

conventional radical laparoscopic prostatectomy

Outcomes

Primary Outcome Measures

Continence restoration at month 3

Subjective report of urinary continence at month 3; R-LRPE vs. LRPE

Secondary Outcome Measures

Outcome of continence - Report of continence using the incontinence-specific quality of life outcome questionnaire ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)

The ICIQ-SF is a subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. The ICIQ is a self-reported survey and screening tool for incontinence. Four main items (of 6 total) ask for rating of symptoms in the past 4 weeks. The sum score of items 3, 4, 5 (items 1 and 2 are demographic) for the actual score is taken. The final item is a self diagnostic item that is unscored. Score is 0 - 21 with a higher score indicating greater severity. Cut-Off Scores: Slight = 1 - 5, Moderate = 6 - 12, Severe = 13 - 18, Very severe = 19 - 21.

Outcome of continence - number of incontinent episodes

Report of the number of incontinent episodes [PAD-use/day]

Outcome of erectile function - IIEF-5

Erectile function including information by the International Index of Erectile Function [IIEF-5]. The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction

Outcome of quality of life - EORTC-QLQ-C30 Questionnaire

The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). Prior to calculating the mean, the symptom scales need to be reversed to obtain a uniform direction of all scales. The summary score should only be calculated if all of the required 13 scale scores are available (using scale scores based on the completed items, provided that at least 50% of the items in that scale have been.

Outcome of quality of life - EORTC-QLQ-PR25 Questionnaire

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire PR25 contains 25 items and is meant for use among patients with prostate cancer varying in disease stage and treatment modality (i.e. surgery, chemotherapy, radiotherapy, etc.). It includes subscales assessing urinary symptoms (9 items), bowel symptoms (4 items), treatment-related symptoms (6 items), and sexual functioning (6 items). Each subscale ranges from 1 (not at all) to 4 (very much). The QLQ-PR25 should always be complemented by the QLQ-C30.

Outcome of quality of life - HADS-D Questionnaire

The Hospital Anxiety and Depression Scale is meant to assess anxiety and depression in patients with physical illness. It contains 14 items with subscales ranging from 1 to 4. If a higher value indicates a better or worse outcome varies with each respective item.

Outcome of quality of life - 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.

PSA value

Measurement of prostate-specific antigen.

Full Information

NCT ID

NCT03682146

First Posted

May 15, 2015

Last Updated

September 21, 2018

Sponsor

University of Leipzig

Collaborators

Universitätsklinikum Düsseldorf, University Hospital Heidelberg, Klinikum Dortmund, Universitätsklinikum Leipzig

1. Study Identification

Unique Protocol Identification Number

NCT03682146

Brief Title

Laparoscopic and Robot-Assisted Radical Prostatectomy - a Comparative Study

Acronym

LAP-01

Official Title

A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robot Radical Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Leipzig

Collaborators

Universitätsklinikum Düsseldorf, University Hospital Heidelberg, Klinikum Dortmund, Universitätsklinikum Leipzig

4. Oversight

5. Study Description

Brief Summary

Men with localized prostate cancer are analyzed. Purpose: This randomized study compares outcomes between robotic-assisted radical prostatectomy and laparoscopic radical prostatectomy

Detailed Description

In recent years robotic-assisted laparoscopic prostatectomy has assumed significant importance in the surgical management of localised prostate cancer. However there is no high quality evidence proving the superiority of the robotic approach over conventional laparoscopic prostatectomy. The study aims to evaluate functional and oncological outcomes between the two approaches. In terms of clinical values, oncologic and continence outcomes, erectile function as well as quality of life - patient satisfaction and psychosocial orientation will be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

DaVinci, Robot Assisted, Prostatectomy, Laparoscopy, Continence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

782 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

R-LRPE

Arm Type

Experimental

Arm Description

robot-assisted laparoscopic prostatectomy

Arm Title

LRPE

Arm Type

Experimental

Arm Description

conventional radical laparoscopic prostatectomy

Intervention Type

Procedure

Intervention Name(s)

Prostatectomy

Other Intervention Name(s)

robot-assisted laparoscopic radical prostatectomy, conventional laparoscopic radical prostatectomy

Intervention Description

Comparison of robot-assisted and conventional laparoscopic radical prostatectomy

Primary Outcome Measure Information:

Title

Continence restoration at month 3

Description

Subjective report of urinary continence at month 3; R-LRPE vs. LRPE

Time Frame

after 3 months

Secondary Outcome Measure Information:

Title

Outcome of continence - Report of continence using the incontinence-specific quality of life outcome questionnaire ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form)

Description

The ICIQ-SF is a subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. The ICIQ is a self-reported survey and screening tool for incontinence. Four main items (of 6 total) ask for rating of symptoms in the past 4 weeks. The sum score of items 3, 4, 5 (items 1 and 2 are demographic) for the actual score is taken. The final item is a self diagnostic item that is unscored. Score is 0 - 21 with a higher score indicating greater severity. Cut-Off Scores: Slight = 1 - 5, Moderate = 6 - 12, Severe = 13 - 18, Very severe = 19 - 21.

Time Frame