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Outcomes from a Pilot Study on the Technical Feasibility of Robotic Assisted Laparoscopic Interpositioning of Processed Nerve Allograft for Reconstruction of the Neurovascular Bundle, with a Twenty-four Month Follow-up Term to Assess Efficacy
Brock O'Neil, MD1; Florence Beck, sCRM2; Donghang Zheng, MD, PhD3; Erick DeVinney, VP2
1Vanderbilt University Medical Center, Nashville, TN, 2AxoGen Inc, Alachua, FL, 3University of Florida, Gainesville, FL
Introduction: In the United States, prostate cancer is the most common form of cancer and the second-leading cause of cancer death in males. In a radical prostatectomy procedure the goal is to remove the prostate and often times surrounding tissues in order to attain a negative surgical margin. In high grade disease the cavernous neurovascular bundle surrounding the prostate may be damaged or removed resulting in loss of erectile function and urinary continence. Historical norms for potency following unilateral resection of the cavernous nerve without reconstruction range from 33-53%, with similar trends observed with incontinence. Reconstruction of these nerves may provide improvements in functional outcomes, however poses a surgical challenge due to a difficult field of view and location. Robot-assisted radical prostatectomy (RARP) has been accepted as the procedure of choice at many centers worldwide since its first introduction in 2000 and provides advancements that could overcome the challenges of reconstructing these nerves. This pilot study was conducted to explore the feasibility of robotic assisted reconstruction of the cavernous nerves using processed nerve allograft.
Methods: Twelve prostate cancer patients with normal pre-operative erectile and urinary function were enrolled to receive robot-assisted radical prostatectomy with unilateral cavernous nerve reconstruction using processed nerve graft. Patients were followed up to 24 months after surgery for erectile and urinary function recovery and any possible adverse event related to nerve graft implantation.
Results: RARP with unilateral cavernous nerve reconstruction was performed following standard procedure, with the steps to implant processed nerve graft incorporated immediately after complete resection of the prostate gland and affected adjacent tissue. All surgeries were successfully performed without any complication and adverse events. The implantation procedure extended operation time by16 ± 4.3 minutes without significant increase of blood loss. Recovery of erectile function (IIEF-6 ?13) was seen in 50% and 70% of patients 12 and 24 months after surgery respectively. Recovery of potency (erection firm enough for intercourse, IIEF ?22) was achieved in 50% of patients 24 months after surgery. Urinary continence (0-1 pad used per day) was restored in 75%, 83.3% and 91.7% of patients by 6, 12 and 24 months after surgery respectively.
Conclusions: Cavernous nerve reconstruction using processed nerve graft during robot-assisted radical prostatectomy is technically feasible and shows promise of desirable functional outcomes. The preliminary efficacy data from this study could be useful in supporting the development of future randomized controlled trials.
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