This randomized clinical trial compares a recently developed technique, called robotic laparoendoscopic single-site radical prostatectomy (R-LESS RP), to the current standard of robotic technique for prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) in treating patients with newly diagnosed, locally confined prostate cancer. Both procedures are types of robotic radical prostatectomy, or the robot-assisted removal of the prostate though a small incision in the belly. In the standard approach, 4-5 small (1-2 cm) incisions are made in the lower abdomen to allow the insertion of robotic instruments. In the R-LESS technique, all instruments are inserted through a single incision. R-LESS RP is less invasive than RALP and may leave a smaller scar and cause less pain.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Undergo RALP
Undergo R-LESS RP
Correlative studies
Mean pain score, evaluated with the visual analog pain score (VAPS)
Compared using the Mann-Whitney U test as appropriate.
Time frame: Up to 1 year
Mean analgesic consumption, obtained from medical charts and reported as units of parenteral morphine equivalents (mg)
Compared using the Mann-Whitney U test as appropriate.
Time frame: Up to 1 month
Time to oral intake
Compared using the Mann-Whitney U test as appropriate.
Time frame: Up to 1 year
Time to resume ambulation
Compared using the Mann-Whitney U test as appropriate.
Time frame: Up to 1 year
Length of hospital stay, counted in whole days from the day of surgery to the day of discharge
Compared using the Mann-Whitney U test as appropriate.
Time frame: Up to 3 days
Operative time, defined as time elapsed from skin incision to placement of the final skin suture
Compared using the Mann-Whitney U test as appropriate.
Time frame: Day 1
Estimated blood loss during surgery
Compared using the Mann-Whitney U test as appropriate.
Time frame: Day 1
Additional ports during surgery
Compared using the Mann-Whitney U test as appropriate.
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Ancillary studies
Ancillary studies
Time frame: Day 1
Incidence of conversion to standard RALP, laparoscopic, or open surgery in R-LESS RP patients
Compared by means of Fisher's exact test.
Time frame: Day 1
Incidence of intraoperative complications
Compared using the Mann-Whitney U test as appropriate.
Time frame: Day 1
Incidence of postoperative complications, recorded according to the Clavien classification
Compared using the Mann-Whitney U test as appropriate.
Time frame: Up to 1 year
Body image perception, measured using the BIQ
Compared using the Mann-Whitney U test as appropriate. The BIQ consists of two scales: the body image scale, which assesses attitudes to bodily appearance and consists of five questions (score 5-20), and the cosmetic scale which assesses degree of satisfaction with the appearance of the scare and consists of three questions (score 3-24).
Time frame: Up to 1 year
Scar evaluation, assessed using the Patient and Observer Scar Assessment Scale
Compared using the Mann-Whitney U test as appropriate. Assessed at suture removal and at 6 months. The Patient and Observer Scar Assessment Scale consists of two scales: the observer scale and the patient scale. Both scales contain 6 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.
Time frame: Up to 1 year
Health related quality of life, measured as patients' perception of functioning, disability, and well-being
Compared using the Mann-Whitney U test as appropriate. Patients' perception of functioning, disability, and well-being will be measured related to the following eight concepts: physical functioning, role limitations cause by physical health problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health.
Time frame: Up to 1 year
Urinary continence, assessed by the number of pads used daily
Compared using the Mann-Whitney U test as appropriate. Evaluated at 1, 3, 6, and 12 months after the procedure.
Time frame: Up to 12 months
Erectile function, assessed by the IIEF-5
Compared using the Mann-Whitney U test as appropriate. Evaluated once in preoperative period and at 1, 3, 6, and 12 months after the procedure.
Time frame: Up to 12 months