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Robotic Athermal Nerve-Sparing Radical Prostatectomy

NCT02079155 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-01-22

No results posted yet for this study

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.

Conditions

  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer

Interventions

PROCEDURE

robot-assisted laparoscopic surgery

Undergo RALP

PROCEDURE

robot-assisted laparoscopic surgery

Undergo R-LESS RP

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

quality-of-life assessment

Ancillary studies

OTHER

questionnaire administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jihad Kaouk · Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
72 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-01-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02079155 on ClinicalTrials.gov