Prostate Cancer
Conditions
Keywords
Prostate cancer, robot, nerve mapping and monitoring
Brief summary
To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.
Detailed description
Using NIM-Eclipse monitoring instrument (Medtronic), we will check action potential of cavernous nerve, bulbocavernosus reflex and pudendal nerve somatosensory evoked potential in real time during robot assisted laparoscopic radical prostatectomy for preservation of erectile function. In this feasibility and protocol setting phase I/II study, we will evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping using NIM-Eclipse monitoring instrument.
Interventions
DEVICENIM-Eclipse
Using NIM-Eclipse, nerve monitoring and mapping are performed
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* pathologically proven localized prostate cancer (≤cT3a) * patients to undergo robot-assisted laparoscopic prostatectomy at our center
Exclusion criteria
* prior hormone therapy * prior radiation treatment on prostate or pelvis * refused to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion rate of nerve monitoring and mapping during RALP | During the operation | Completion rate of planed surgery without significant intra-operative complication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | 12 months | Rate of adverse events during and after procedures upto 12 months |
| Quantification of erectile nerve preservation | During the operation | Changes in action potential after prostate removal from the baseline. Electrical stimulation will be given at each neurovascular bundle 3 times. Action potential will be measured at both corpus cavernosum. |
| Correlation between the quantification and subjective nerve preservation grade | During the operation | Mean value of the quantification by nerve preservation grade (Tewari et al, 2011) which was subjectively scored by the surgeon. |
| Correlation between the quantification of erectile nerve preservation and the postoperative recovery of erectile function | 12 months | Recovery duration of erection measured by the International Index of Erectile Dysfunction(IIEF)-5 score according to the quantification of erectile nerve preservation |
Countries
South Korea
Outcome results
None listed