Clinical Trials /

Single-Port Versus Multi-Port Robotic Radical Prostatectomy

NCT04696263

Description:

The purpose of this study is to compare two different techniques to perform the standard of care surgery to treat prostate cancer. This surgery is called robotic radical prostatectomy. There are two robotic surgical systems approved by the Food and Drug Administration (FDA) to perform this surgery. First system is called the Da Vinci ® Xi system. With this system, six small incisions are made during the surgery. Second system is called the Da Vinci ® SP system. With this system a single incision is made during the surgery. Same surgery is done with each surgical system. This study aims to understand whether a single incision surgery ends up with better recovery after surgery.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Single-Port Versus Multi-Port Robotic Radical Prostatectomy
  • Official Title: Prospective Single-Center Randomized Study Of Single-Port Versus Multi-Port Robotic Radical Prostatectomy

Clinical Trial IDs

  • ORG STUDY ID: CASE7820
  • NCT ID: NCT04696263

Conditions

  • Malignant Neoplasm of Prostate

Purpose

The purpose of this study is to compare two different techniques to perform the standard of care surgery to treat prostate cancer. This surgery is called robotic radical prostatectomy. There are two robotic surgical systems approved by the Food and Drug Administration (FDA) to perform this surgery. First system is called the Da Vinci ® Xi system. With this system, six small incisions are made during the surgery. Second system is called the Da Vinci ® SP system. With this system a single incision is made during the surgery. Same surgery is done with each surgical system. This study aims to understand whether a single incision surgery ends up with better recovery after surgery.

Trial Arms

NameTypeDescriptionInterventions
Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system)Active ComparatorAll participants will undergo SOC robotic radical prostatectomy. The procedure for this arm uses the Da Vinci ® SP system. Access point consists of one 3.5 cm single infraumbilical incision for the SP-RARP
    Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system)Active ComparatorAll participants will undergo SOC robotic radical prostatectomy. The procedure for this arm uses the Da Vinci ® Xi system, where four 8mm trocars will be used along with a 12 mm assistant trocar (a surgical instrument) to create six small incisions during the surgery

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Participants must have histologically or cytologically confirmed prostate cancer,
                   stage T1a, T2a or T2b prostate cancer using MRI staging.
      
                -  Life expectancy greater than 10 years.
      
                -  Participants must have ability to understand and the willingness to sign a written
                   informed consent document or have a surrogate with the ability to understand and the
                   willingness to sign a written informed consent for radical prostatectomy.
      
              Exclusion Criteria:
      
                -  Participants with any prior extensive pelvic surgery or pelvic fractures.
      
                -  Prior treatment for prostate cancer such as radiotherapy or focal therapy.
      
                -  Uncorrected coagulopathy.
      
                -  Active soft tissue or urinary infection.
      
                -  Poor surgical risk (defined as American Society of Anesthesiology score > 3)
      
                -  Any condition or history of illness or surgery that, in the opinion of the
                   investigator, might confound the results of the study or pose additional risk to the
                   patient (e.g. significant cardiovascular conditions that significantly affect the life
                   expectancy, chronic opiate use, pain syndrome, or drug abuse.)
      
                -  Participants with uncontrolled intercurrent illness including, but not limited to
                   ongoing or active infection, symptomatic congestive heart failure, unstable angina
                   pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
                   limit compliance with study requirements
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:19 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Hospital stay in hours
      Time Frame:Post-surgery, an average of 16 hours
      Safety Issue:
      Description:Hospital stay, counted in hours from the time of transfer to the post anesthesia care unit (PACU) to discharge

      Secondary Outcome Measures

      Measure:Operative time
      Time Frame:During operation, an average operative time is 192 minutes
      Safety Issue:
      Description:Time elapsed from skin incision to placement of the final skin suture
      Measure:Estimated blood loss in milliliters
      Time Frame:During operation, an average operative time is 192 minutes
      Safety Issue:
      Description:Estimated blood loss, measured in volume (mL)
      Measure:Number of additional ports
      Time Frame:Within 24 hours of surgery
      Safety Issue:
      Description:Number of additional ports needed in surgery
      Measure:Number of SP procedures converted to other procedure types
      Time Frame:Within 24 hours of surgery
      Safety Issue:
      Description:For SP procedures, conversion to MP robotic surgery or standard laparoscopic surgery, or open surgery will be recorded
      Measure:Intraoperative complication rate
      Time Frame:Within 24 hours of surgery
      Safety Issue:
      Description:Intraoperative complication rate compared between the two systems
      Measure:Number of participants requiring Intraoperative Trendelenburg position
      Time Frame:Within 24 hours of surgery
      Safety Issue:
      Description:Intraoperative Trendelenburg position requirement for the participant will be recorded. Position involves placing the head low and feet elevated, increasing blood return to the heart, cardiac output and vital organ perfusion
      Measure:Intraoperative peritoneum breach rate
      Time Frame:Within 24 hours of surgery
      Safety Issue:
      Description:Intraoperative peritoneum breach rate as defined by intraoperative pneumoperitoneum after insufflation of extraperitoneal space
      Measure:Visual analog pain scale scores
      Time Frame:Within 7 days of surgery
      Safety Issue:
      Description:Pain intensity will be evaluated with a visual analog pain scale, a validated instrument scored from 0 to 10, 10 being the worst
      Measure:Units of parenteral morphine equivalents (mg)
      Time Frame:Up to 1 month post-procedure
      Safety Issue:
      Description:Analgesic requirements will be obtained from medical charts and reported as units of parenteral morphine equivalents (mg)
      Measure:Time to liquid oral intake
      Time Frame:Post-surgery, an average of 16 hours
      Safety Issue:
      Description:Time to liquid oral intake
      Measure:Time to solid oral intake
      Time Frame:Post-surgery, an average of 16 hours
      Safety Issue:
      Description:Time to solid oral intake
      Measure:Number of postoperative complications
      Time Frame:Within 30 days
      Safety Issue:
      Description:Postoperative complications recorded according to the Clavien- Dindo classification
      Measure:Body image questionnaire scores
      Time Frame:Up to 1 year
      Safety Issue:
      Description:Body image perception, measured using the body image questionnaire, which consists of two sub-scales: the body image scale, which assesses attitudes to bodily appearance and consists of five questions (score 5-20) where higher scores mean worse outcomes, and the cosmetic scale which assesses the degree of satisfaction with the appearance of the scar and consists of three questions (score 3-24), where higher scores mean worse outcomes.
      Measure:Participant and Observer Scar Assessment Scale scores
      Time Frame:Up to 1 year
      Safety Issue:
      Description:Scar evaluation by using a validated assessment tool, the Participant and Observer Scar Assessment Scale.17 It consists of two scales: the observer scale and the participant scale (Figs. 1 and 2). Both scales contain six items that are scored numerically. Each of the six items on both scales has a 10-step score, with 10 indicating the worst imaginable scar or sensation. The total score of both scales consists of adding the scores of each of the six items (range, 6 to 60). The lowest score, 6, reflects normal skin, whereas the highest score, 60, reflects the worst imaginable scar.
      Measure:Number of pads used daily
      Time Frame:Up to 1 year
      Safety Issue:
      Description:Urinary continence, assessing the number of pads used daily. Continence will be defined as the absence of pads (even safety pads)
      Measure:International Index of Erectile Function (IIEF-5) scale scores
      Time Frame:Up to 1 year
      Safety Issue:
      Description:Erectile Function assessed by the IIEF-5 scale, consisting of 5 questions, with scores ranging from 5-25. 25 being great and 5 being the worst
      Measure:Time to return-to-work
      Time Frame:Up to 1 year
      Safety Issue:
      Description:Time to return-to-work, reported in days
      Measure:Time to baseline
      Time Frame:Up to 1 year
      Safety Issue:
      Description:Time to baseline defined as the amount of time between surgery and when the patient becomes pain free and does not need painkillers

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:Case Comprehensive Cancer Center

      Last Updated

      March 16, 2021