Clinical trial NCT04696263: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Malignant Neoplasm of Prostate
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 0
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recovery of Urinary Continence Following Catheter Removal
timeFrame: Up to 12 months post-treatment
Secondary outcomes:
measure: Operative time
timeFrame: During operation, an average operative time is 192 minutes
measure: Estimated blood loss in milliliters
timeFrame: During operation, an average operative time is 192 minutes
measure: Number of additional ports
timeFrame: Within 24 hours of surgery
measure: Number of SP procedures converted to other procedure types
timeFrame: Within 24 hours of surgery
measure: Intraoperative complication rate
timeFrame: Within 24 hours of surgery
measure: Number of participants requiring Intraoperative Trendelenburg position
timeFrame: Within 24 hours of surgery
measure: Intraoperative peritoneum breach rate
timeFrame: Within 24 hours of surgery
measure: Visual analog pain scale scores
timeFrame: Within 7 days of surgery
measure: Units of parenteral morphine equivalents (mg)
timeFrame: Up to 1 month post-procedure
measure: Time to liquid oral intake
timeFrame: Post-surgery, an average of 16 hours
measure: Time to solid oral intake
timeFrame: Post-surgery, an average of 16 hours
measure: Number of postoperative complications
timeFrame: Within 30 days
measure: Body image questionnaire scores
timeFrame: Up to 1 year
measure: Participant and Observer Scar Assessment Scale scores
timeFrame: Up to 1 year
measure: Number of pads used daily
timeFrame: Up to 1 year
measure: International Index of Erectile Function (IIEF-5) scale scores
timeFrame: Up to 1 year
measure: Time to return-to-work
timeFrame: Up to 1 year
measure: Time to baseline
timeFrame: Up to 1 year
measure: Hospital stay in hours
timeFrame: Post-surgery, an average of 16 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Jihad Kaouk, MD
role: PRINCIPAL_INVESTIGATOR
References: