Single-Port Versus Multi-Port Robotic Radical Prostatectomy

Malignant Neoplasm of Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04696263
• Other study ID #: CASE7820
• Status: Suspended
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 66
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm of Prostate
• Neoplasms
• Prostatic Neoplasms

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of Urinary Continence Following Catheter Removal	Continence will be defined as the absence of pads (even safety pads).	Up to 12 months post-treatment
Secondary	Operative time	Time elapsed from skin incision to placement of the final skin suture	During operation, an average operative time is 192 minutes
Secondary	Estimated blood loss in milliliters	Estimated blood loss, measured in volume (mL)	During operation, an average operative time is 192 minutes
Secondary	Number of additional ports	Number of additional ports needed in surgery	Within 24 hours of surgery
Secondary	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	Within 24 hours of surgery
Secondary	Intraoperative complication rate	Intraoperative complication rate compared between the two systems	Within 24 hours of surgery
Secondary	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	Within 24 hours of surgery
Secondary	Intraoperative peritoneum breach rate	Intraoperative peritoneum breach rate as defined by intraoperative pneumoperitoneum after insufflation of extraperitoneal space	Within 24 hours of surgery
Secondary	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	Within 7 days of surgery
Secondary	Units of parenteral morphine equivalents (mg)	Analgesic requirements will be obtained from medical charts and reported as units of parenteral morphine equivalents (mg)	Up to 1 month post-procedure
Secondary	Time to liquid oral intake	Time to liquid oral intake	Post-surgery, an average of 16 hours
Secondary	Time to solid oral intake	Time to solid oral intake	Post-surgery, an average of 16 hours
Secondary	Number of postoperative complications	Postoperative complications recorded according to the Clavien- Dindo classification	Within 30 days
Secondary	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.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	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)	Up to 1 year
Secondary	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	Up to 1 year
Secondary	Time to return-to-work	Time to return-to-work, reported in days	Up to 1 year
Secondary	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	Up to 1 year
Secondary	Hospital stay in 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