Robotic Athermal Nerve-Sparing Radical Prostatectomy

Stage I Prostate Cancer Clinical Trial

Official title: Prospective Single-Center Randomized Study of Robotic Athermal Nerve-Sparing Radical Prostatectomy: Laparoendoscopic Single-Site Versus Standard Approach

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer

• NCT number: NCT02079155
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Withdrawn
• Phase: N/A
• Start date: June 2012
• Completion date: January 2016