Robotic Athermal Nerve-Sparing Radical Prostatectomy

PRIMARY OBJECTIVES:

I. To evaluate pain and analgesic requirement of R-LESS RP compared to standard RALP.

SECONDARY OBJECTIVES:

I. Time to oral intake. II. Time to resume ambulation. III. Hospital stay, counted in whole
days from the day of surgery to the day of discharge.

IV. Perioperative parameters, including: operative time (defined as time elapsed from skin
incision to placement of the final skin suture); estimated blood loss; additional ports;
conversion to standard RALP (in R-LESS RP patients), or laparoscopic, or open surgery;
length of stay.

V. Intraoperative complications. VI. Postoperative complications, recorded according to the
Clavien classification.

VII. Body image perception, measured using the body image questionnaire (BIQ). VIII. Scar
evaluation (at suture removal and at 6 month) by using a validated assessment tool, the
Patient and Observer Scar Assessment Scale.

IX. Health related quality of life, measured as patients' perception of functioning,
disability, and well-being related to the following eight concepts: physical functioning,
role limitations caused by physical health problems, bodily pain, general health, vitality,
social functioning, role limitation caused by emotional problems, and mental health.

X. Urinary continence, assessing the number of pads used daily. XI. Erectile Function,
assessed by the International Index of Erectile Function (IIEF-5).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard RALP.

ARM II: Patients undergo R-LESS RP.

After completion of study treatment, patients are followed up periodically for 1 year.

Inclusion Criteria:

- Patients must have a biopsy proven newly diagnosed locally confined, stage T1a, T2a
or T2b prostate cancer

- Judged by the study doctor to be a suitable candidate for a radical prostatectomy

- Serum prostate specific antigen equal to or less than 10 ng/mL

- Gleason score equal to or less than 7

- Life expectancy greater than 10 years

- Prostate size on trans-rectal ultrasound (TRUS) measurement less than 50 grams

- Favorable operative risk defined as American Society of Anesthesiology Score (ASA
score) =< 3

- 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

Exclusion Criteria:

- Patients with any prior pelvic surgery

- Patients with prior history of pelvic fractures or hip replacement

- Large pelvic or intra-abdominal masses

- 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)

- Poor surgical risk (defined as American Society of Anesthesiology Score > 3)

- Active infection

- Uncorrected coagulopathy

- Body mass index equal to or greater than 35