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To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerve monitoring arm | Experimental | They will receive pelvic autonomic nerve monitoring and mapping using NIM-Eclipse (Medtronic) during robot-assisted laparoscopic prostatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIM-Eclipse | Device | Using NIM-Eclipse, nerve monitoring and mapping are performed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of nerve monitoring and mapping during RALP | Completion rate of planed surgery without significant intra-operative complication | During the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Rate of adverse events during and after procedures upto 12 months | 12 months |
| Quantification of erectile nerve preservation | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang Wook Jeong, M.D., Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
No part of IPD will be shared.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| During the operation |
| Correlation between the quantification and subjective nerve preservation grade | Mean value of the quantification by nerve preservation grade (Tewari et al, 2011) which was subjectively scored by the surgeon. | During the operation |
| Correlation between the quantification of erectile nerve preservation and the postoperative recovery of erectile function | Recovery duration of erection measured by the International Index of Erectile Dysfunction(IIEF)-5 score according to the quantification of erectile nerve preservation | 12 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |