Single-Port Versus Multi-Port Robotic Radical Prostatectomy

Not Applicable

Withdrawn

• Conditions: Malignant Neoplasm of Prostate

• Registration Number: NCT04696263
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Study Start: 2022-09-01
• Status Verified: 2025-03
• Primary Completion: 2025-03
• Study Completion: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recovery of Urinary Continence Following Catheter Removal	Up to 12 months post-treatment	Continence will be defined as the absence of pads (even safety pads).

Secondary Outcome Measures

Name	Time	Method
Estimated blood loss in milliliters	During operation, an average operative time is 192 minutes	Estimated blood loss, measured in volume (mL)
Number of participants requiring Intraoperative Trendelenburg position	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
Number of SP procedures converted to other procedure types	Within 24 hours of surgery	For SP procedures, conversion to MP robotic surgery or standard laparoscopic surgery, or open surgery will be recorded
Time to solid oral intake	Post-surgery, an average of 16 hours	Time to solid oral intake
Participant and Observer Scar Assessment Scale scores	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.
Number of pads used daily	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)
Operative time	During operation, an average operative time is 192 minutes	Time elapsed from skin incision to placement of the final skin suture
Number of additional ports	Within 24 hours of surgery	Number of additional ports needed in surgery
Intraoperative complication rate	Within 24 hours of surgery	Intraoperative complication rate compared between the two systems
Intraoperative peritoneum breach rate	Within 24 hours of surgery	Intraoperative peritoneum breach rate as defined by intraoperative pneumoperitoneum after insufflation of extraperitoneal space
Visual analog pain scale scores	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
Units of parenteral morphine equivalents (mg)	Up to 1 month post-procedure	Analgesic requirements will be obtained from medical charts and reported as units of parenteral morphine equivalents (mg)
Time to liquid oral intake	Post-surgery, an average of 16 hours	Time to liquid oral intake
Body image questionnaire scores	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.
International Index of Erectile Function (IIEF-5) scale scores	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
Time to return-to-work	Up to 1 year	Time to return-to-work, reported in days
Number of postoperative complications	Within 30 days	Postoperative complications recorded according to the Clavien- Dindo classification
Time to baseline	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
Hospital stay in hours	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

Trial Locations

Locations (1)

Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States