Back to resultsSingle-Port Versus Multi-Port Robotic Radical Prostatectomy
Primary Purpose
Malignant Neoplasm of Prostate
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Da Vinci ® Xi system - MP Robotic Radical Prostatectomy
Da Vinci ® SP system - SP Robotic Radical Prostatectomy
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Neoplasm of Prostate
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
Sites / Locations
- Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system)
Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system)
Arm Description
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
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
Outcomes
Primary Outcome Measures
Recovery of Urinary Continence Following Catheter Removal
Continence will be defined as the absence of pads (even safety pads).
Secondary Outcome Measures
Operative time
Time elapsed from skin incision to placement of the final skin suture
Estimated blood loss in milliliters
Estimated blood loss, measured in volume (mL)
Number of additional ports
Number of additional ports needed in surgery
Number of SP procedures converted to other procedure types
For SP procedures, conversion to MP robotic surgery or standard laparoscopic surgery, or open surgery will be recorded
Intraoperative complication rate
Intraoperative complication rate compared between the two systems
Number of participants requiring Intraoperative Trendelenburg position
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
Intraoperative peritoneum breach rate
Intraoperative peritoneum breach rate as defined by intraoperative pneumoperitoneum after insufflation of extraperitoneal space
Visual analog pain scale scores
Pain intensity will be evaluated with a visual analog pain scale, a validated instrument scored from 0 to 10, 10 being the worst
Units of parenteral morphine equivalents (mg)
Analgesic requirements will be obtained from medical charts and reported as units of parenteral morphine equivalents (mg)
Time to liquid oral intake
Time to liquid oral intake
Time to solid oral intake
Time to solid oral intake
Number of postoperative complications
Postoperative complications recorded according to the Clavien- Dindo classification
Body image questionnaire scores
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.
Participant and Observer Scar Assessment Scale scores
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.
Number of pads used daily
Urinary continence, assessing the number of pads used daily. Continence will be defined as the absence of pads (even safety pads)
International Index of Erectile Function (IIEF-5) scale scores
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
Time to return-to-work
Time to return-to-work, reported in days
Time to baseline
Time to baseline defined as the amount of time between surgery and when the patient becomes pain free and does not need painkillers
Hospital stay in hours
Hospital stay, counted in hours from the time of transfer to the post anesthesia care unit (PACU) to discharge
Full Information
NCT ID
NCT04696263
First Posted
January 4, 2021
Last Updated
July 24, 2023
Sponsor
Case Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04696263
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Suspended
Why Stopped
Administrative delays
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of Prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Da Vinci ® Xi system - MP Robotic Radical Prostatectomy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Da Vinci ® SP system - SP Robotic Radical Prostatectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Recovery of Urinary Continence Following Catheter Removal
Description
Continence will be defined as the absence of pads (even safety pads).
Time Frame
Up to 12 months post-treatment
Secondary Outcome Measure Information:
Title
Operative time
Description
Time elapsed from skin incision to placement of the final skin suture
Time Frame
During operation, an average operative time is 192 minutes
Title
Estimated blood loss in milliliters
Description
Estimated blood loss, measured in volume (mL)
Time Frame
During operation, an average operative time is 192 minutes
Title
Number of additional ports
Description
Number of additional ports needed in surgery
Time Frame
Within 24 hours of surgery
Title
Number of SP procedures converted to other procedure types
Description
For SP procedures, conversion to MP robotic surgery or standard laparoscopic surgery, or open surgery will be recorded
Time Frame
Within 24 hours of surgery
Title
Intraoperative complication rate
Description
Intraoperative complication rate compared between the two systems
Time Frame
Within 24 hours of surgery
Title
Number of participants requiring Intraoperative Trendelenburg position
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
Time Frame
Within 24 hours of surgery
Title
Intraoperative peritoneum breach rate
Description
Intraoperative peritoneum breach rate as defined by intraoperative pneumoperitoneum after insufflation of extraperitoneal space
Time Frame
Within 24 hours of surgery
Title
Visual analog pain scale scores
Description
Pain intensity will be evaluated with a visual analog pain scale, a validated instrument scored from 0 to 10, 10 being the worst
Time Frame
Within 7 days of surgery
Title
Units of parenteral morphine equivalents (mg)
Description
Analgesic requirements will be obtained from medical charts and reported as units of parenteral morphine equivalents (mg)
Time Frame
Up to 1 month post-procedure
Title
Time to liquid oral intake
Description
Time to liquid oral intake
Time Frame
Post-surgery, an average of 16 hours
Title
Time to solid oral intake
Description
Time to solid oral intake
Time Frame
Post-surgery, an average of 16 hours
Title
Number of postoperative complications
Description
Postoperative complications recorded according to the Clavien- Dindo classification
Time Frame
Within 30 days
Title
Body image questionnaire scores
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.
Time Frame
Up to 1 year
Title
Participant and Observer Scar Assessment Scale scores
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.
Time Frame
Up to 1 year
Title
Number of pads used daily
Description
Urinary continence, assessing the number of pads used daily. Continence will be defined as the absence of pads (even safety pads)
Time Frame
Up to 1 year
Title
International Index of Erectile Function (IIEF-5) scale scores
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
Time Frame
Up to 1 year
Title
Time to return-to-work
Description
Time to return-to-work, reported in days
Time Frame
Up to 1 year
Title
Time to baseline
Description
Time to baseline defined as the amount of time between surgery and when the patient becomes pain free and does not need painkillers
Time Frame
Up to 1 year
Title
Hospital stay in hours
Description
Hospital stay, counted in hours from the time of transfer to the post anesthesia care unit (PACU) to discharge
Time Frame
Post-surgery, an average of 16 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihad Kaouk, MD
Organizational Affiliation
Cleveland Clinic, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This trial will not study a drug, device, biological/vaccine, radiation, genetic, combination product or diagnostic test
Learn more about this trial
Single-Port Versus Multi-Port Robotic Radical Prostatectomy
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