Single-Port Versus Multi-Port Robotic Radical Prostatectomy for the Treatment of Prostate Cancer

Status: withdrawn

This phase III trial compares the effect of single-port versus multi-port robotic radical prostatectomy in treating patients with prostate cancer. Single-port robotic radical prostatectomy is a surgery during which a single incision is made. Multi-port robotic radical prostatectomy is a surgery during which six small incisions are made. This study aims to understand whether a single incision surgery ends up with better recovery after surgery.

Inclusion Criteria

Subjects must have histologically or cytologically confirmed prostate cancer, low risk or intermediate risk according to the National Comprehensive Cancer Network (NCCN) Risk Stratification
Life expectancy greater than 10 years
Age > 18 years
Subjects 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

Patients 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
Subjects 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 OBJECTIVE:

I. Urinary continence, assessing the number of pads used daily.

SECONDARY OBJECTIVES:

I. Evaluation of hospital stay, counted in hours from the time of transfer to the post anesthesia care unit (PACU) to discharge.

II. Perioperative parameters, including operative time (defined as the time elapsed from skin incision to placement of the final skin suture); estimated blood loss; additional ports; conversion to multi-port (MP) robotic surgery (for single-port [SP] procedures), or standard laparoscopic surgery, or open surgery.

III. Intraoperative complication comparison.

IV. Intraoperative Trendelenburg position requirement for the patient.

V. Intraoperative peritoneum breach rate as defined by intraoperative pneumoperitoneum after insufflation of extraperitoneal space.

VI. Pain and analgesic requirement of SP surgery compared to MP surgery.

VII. Pain intensity will be evaluated with a visual analog pain scale, a validated instrument.

VIII. Analgesic requirements will be obtained from medical charts and reported as units of parenteral morphine equivalents (mg).

IX. Time to solid and liquid oral intake.

X. Postoperative complications recorded according to the Clavien- Dindo classification.

XI. Body image perception, measured using the body image questionnaire.

XII. Scar evaluation (at postoperative visit and after 6 months) by using a validated assessment tool, the Patient and Observer Scar Assessment Scale.

XIII. Erectile function assessed by the International Index of Erectile Function (IIEF-5) scale.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo robotic radical prostatectomy with the multi-port approach involving 5 or 6 incisions approximately 1 cm in size each.

ARM II : Patients undergo robotic radical prostatectomy with the single-port approach involving 1 incision approximately 3 cm in size.

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Single-Port Versus Multi-Port Robotic Radical Prostatectomy for the Treatment of Prostate Cancer

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