Single-Port Versus Multi-Port Robotic Radical Prostatectomy

March 7, 2025 updated by: Case Comprehensive Cancer Center

Prospective Single-Center Randomized Study Of Single-Port Versus Multi-Port Robotic Radical Prostatectomy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jihad Kaouk, MD
  • Phone Number: 1-866-223-8100
  • Email: kaoukj@ccf.org

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system)

All 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
Device: Da Vinci ® SP system - SP Robotic Radical Prostatectomy
After induction of general anesthesia and supine participant positioning, a 3.5 cm infraumbilical incision will be made for single-port access into the space of Retzius. Radical prostatectomy is then performed with the SOC approach
Active Comparator: Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system)

All 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
Device: Da Vinci ® Xi system - MP Robotic Radical Prostatectomy
After pneumoperitoneum is established, four 8mm, one 12 mm, and one 5 mm trocars are placed for instrumentation. After the robot is docked, radical prostatectomy is performed with the SOC approach.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recovery of Urinary Continence Following Catheter Removal
Time Frame: Up to 12 months post-treatment
Continence will be defined as the absence of pads (even safety pads).
Up to 12 months post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: During operation, an average operative time is 192 minutes
Time elapsed from skin incision to placement of the final skin suture
During operation, an average operative time is 192 minutes
Estimated blood loss in milliliters
Time Frame: During operation, an average operative time is 192 minutes
Estimated blood loss, measured in volume (mL)
During operation, an average operative time is 192 minutes
Number of additional ports
Time Frame: Within 24 hours of surgery
Number of additional ports needed in surgery
Within 24 hours of surgery
Number of SP procedures converted to other procedure types
Time Frame: Within 24 hours of surgery
For SP procedures, conversion to MP robotic surgery or standard laparoscopic surgery, or open surgery will be recorded
Within 24 hours of surgery
Intraoperative complication rate
Time Frame: Within 24 hours of surgery
Intraoperative complication rate compared between the two systems
Within 24 hours of surgery
Number of participants requiring Intraoperative Trendelenburg position
Time Frame: Within 24 hours of surgery
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
Within 24 hours of surgery
Intraoperative peritoneum breach rate
Time Frame: Within 24 hours of surgery
Intraoperative peritoneum breach rate as defined by intraoperative pneumoperitoneum after insufflation of extraperitoneal space
Within 24 hours of surgery
Visual analog pain scale scores
Time Frame: Within 7 days of surgery
Pain intensity will be evaluated with a visual analog pain scale, a validated instrument scored from 0 to 10, 10 being the worst
Within 7 days of surgery
Units of parenteral morphine equivalents (mg)
Time Frame: Up to 1 month post-procedure
Analgesic requirements will be obtained from medical charts and reported as units of parenteral morphine equivalents (mg)
Up to 1 month post-procedure
Time to liquid oral intake
Time Frame: Post-surgery, an average of 16 hours
Time to liquid oral intake
Post-surgery, an average of 16 hours
Time to solid oral intake
Time Frame: Post-surgery, an average of 16 hours
Time to solid oral intake
Post-surgery, an average of 16 hours
Number of postoperative complications
Time Frame: Within 30 days
Postoperative complications recorded according to the Clavien- Dindo classification
Within 30 days
Body image questionnaire scores
Time Frame: Up to 1 year
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.
Up to 1 year
Participant and Observer Scar Assessment Scale scores
Time Frame: Up to 1 year
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.
Up to 1 year
Number of pads used daily
Time Frame: Up to 1 year
Urinary continence, assessing the number of pads used daily. Continence will be defined as the absence of pads (even safety pads)
Up to 1 year
International Index of Erectile Function (IIEF-5) scale scores
Time Frame: Up to 1 year
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
Up to 1 year
Time to return-to-work
Time Frame: Up to 1 year
Time to return-to-work, reported in days
Up to 1 year
Time to baseline
Time Frame: Up to 1 year
Time to baseline defined as the amount of time between surgery and when the patient becomes pain free and does not need painkillers
Up to 1 year
Hospital stay in hours
Time Frame: Post-surgery, an average of 16 hours
Hospital stay, counted in hours from the time of transfer to the post anesthesia care unit (PACU) to discharge
Post-surgery, an average of 16 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jihad Kaouk, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CASE7820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This trial will not study a drug, device, biological/vaccine, radiation, genetic, combination product or diagnostic test

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

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