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Laparoscopic and Robot-Assisted Radical Prostatectomy - a Comparative Study (LAP-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682146
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Collaborators:
Universitätsklinikum Düsseldorf
University Hospital Heidelberg
Klinikum Dortmund
Universitätsklinikum Leipzig
Information provided by (Responsible Party):
Dr. Sigrun Holze, University of Leipzig

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Prostatectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 782 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robot Radical Prostatectomy
Study Start Date : November 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: R-LRPE
robot-assisted laparoscopic prostatectomy
Procedure: Prostatectomy
Comparison of robot-assisted and conventional laparoscopic radical prostatectomy
Other Names:
  • robot-assisted laparoscopic radical prostatectomy
  • conventional laparoscopic radical prostatectomy

Experimental: LRPE
conventional radical laparoscopic prostatectomy
Procedure: Prostatectomy
Comparison of robot-assisted and conventional laparoscopic radical prostatectomy
Other Names:
  • robot-assisted laparoscopic radical prostatectomy
  • conventional laparoscopic radical prostatectomy




Primary Outcome Measures :
  1. Continence restoration at month 3 [ Time Frame: after 3 months ]
    Subjective report of urinary continence at month 3; R-LRPE vs. LRPE


Secondary Outcome Measures :
  1. Outcome of continence - Report of continence using the incontinence-specific quality of life outcome questionnaire ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form) [ Time Frame: 1, 3, 6, 12 months postoperative ]
    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.

  2. Outcome of continence - number of incontinent episodes [ Time Frame: 1, 3, 6, 12 months postoperative ]
    Report of the number of incontinent episodes [PAD-use/day]

  3. Outcome of erectile function - IIEF-5 [ Time Frame: 1, 3, 6, 12 months postoperative ]
    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

  4. Outcome of quality of life - EORTC-QLQ-C30 Questionnaire [ Time Frame: 1, 3, 6, 12 months postoperative ]
    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.

  5. Outcome of quality of life - EORTC-QLQ-PR25 Questionnaire [ Time Frame: 1, 3, 6, 12 months postoperative ]
    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.

  6. Outcome of quality of life - HADS-D Questionnaire [ Time Frame: 1, 3, 6, 12 months postoperative ]
    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.

  7. Outcome of quality of life - Patient satisfaction [ Time Frame: 1, 3, 6, 12 months postoperative ]
    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.

  8. PSA value [ Time Frame: 1, 3, 6, 12, 24, 36 months postoperative ]
    Measurement of prostate-specific antigen.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682146


Contacts
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Contact: Sigrun Holze, PhD LAP-01@uniklinik-leipzig.de

Locations
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Germany
Klinikum Dortmund Recruiting
Dortmund, Germany, 44137
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany, 40225
University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Sponsors and Collaborators
University of Leipzig
Universitätsklinikum Düsseldorf
University Hospital Heidelberg
Klinikum Dortmund
Universitätsklinikum Leipzig
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Responsible Party: Dr. Sigrun Holze, Clinical Trials Research Coordinator, University of Leipzig
ClinicalTrials.gov Identifier: NCT03682146    
Other Study ID Numbers: LAP-01
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Keywords provided by Dr. Sigrun Holze, University of Leipzig:
DaVinci
Robot Assisted
Prostatectomy
Laparoscopy
Continence
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases