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OpenTrials
Completed

NCT Number: NCT02352103

Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery

To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.

Completed

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Key information

About this study

Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as the primary treatment modality
  • Be able to read and speak English and be able to provide written informed consent

Exclusion criteria

  • patients with high risk prostate cancer,defined as a biopsy Gleason score ≥8 and/or a pre-operative prostate specific antigen value ≥20 ng/ml.
  • evidence of clinical nodal involvement (cN1) or metastatic disease (M1)
  • patients participating in a competing study
  • patients with pre-operative urinary incontinence.

Treatment and study plan

Retzius sparing radical prostatectomy

Procedure

Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique

Vattikuti Urology Institute radical prostatectomy

Procedure

Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique

da Vinci Surgical System

Device

The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.

Primary outcomes

  1. Urinary Continence Recovery

    Time frame: One week after the removal of the suprapubic urinary catheter

    24-hour pad weights

Secondary outcomes

  1. Number of Participants With Urinary Continence Recovery

    Time frame: within 3 months from the intervention

    0 pad per day

  2. Number of Participants With Peri and Postoperative Complications

    Time frame: 1-year median follow up

    Clavien-Dindo complications

  3. Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)

    Time frame: 1-year median follow up

    SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of >=22 is normal and >=17 is considered mild ED

  4. Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)

    Time frame: 1-year median follow up

    Patients without biochemical evidence of disease recurrence (i.e. postop PSA >=0.2 ng/mL)

  5. Post-operative Urinary Function and Urinary Function-related Quality of Life

    Time frame: Within 3 months from the intervention

    International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)

Other outcomes

  1. Number of Patients Who Regained Urinary Continence Postoperatively

    Time frame: 1 year median follow up

    0 pad per day

  2. Post-operative Urinary Function and Urinary Function-related Quality of Life

    Time frame: 1 year median follow up

    MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Feb 2, 2015
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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