Nerve monitoring during robotic radical prostatectomy
| ISRCTN | ISRCTN09760775 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09760775 |
| Secondary identifying numbers | TD-07661 |
- Submission date
- 11/01/2013
- Registration date
- 18/01/2013
- Last edited
- 05/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Treatment of prostate cancer commonly involves an operation to remove the prostate (a radical prostatectomy) in either open, laparoscopic, or robot-assisted procedures. Erectile dysfunction is a possible side-effect for patients after having a radical prostatectomy. This is because the nerves that are responsible for controlling erectile function can be injured during the surgery.
The investigators of this study want to find out if a nerve monitoring device is able to monitor the nerves surrounding the prostate, which are responsible for controlling erectile function.
Who can participate?
Adult males between 18 and 75 years of age who are undergoing robotic radical prostatectomy with no history of significant erectile dysfunction will be asked to participate.
What does the study involve?
All eligible patients who chose to participate in the study will receive the same treatment. During the radical prostatectomy procedure, but before the prostate is removed, the nerve monitor will be used to stimulate and record the nerves surrounding the prostate. After the nerve monitoring, the operation will proceed as usual. Following the surgery, patients will have follow up visits with the doctor as usual. At 3 months and 6 months, they will complete a questionnaire regarding their erectile function. The same questionnaire is also completed by patients before the operation.
What are the possible benefits and risks of participating?
There is no guarantee that participating patients will receive any benefits from this study. However, others may be helped by what is learned from this research.
Intraoperative nerve monitoring has a long successful clinical history in other areas of the body, and the use of the nerve monitor device during prostatectomy is not expected to add significant risk. However, nerve monitoring during prostatectomy is experimental, so the procedure could involve risks which are currently unknown. All foreseeable risks are explained to the patients before they chose to participate.
Where is the study run from?
This study is being conducted at Columbia University Medical Center and Weill Cornell Medical College. Between the two sites, 30 patients will be enrolled into the study.
When is the study starting and how long is it expected to run for?
The study is expected to start in mid-January of 2013, and will last until all participating patients have completed their 6 month follow up (around October 2013).
Who is funding the study?
Medtronic, Inc.
Who is the main contact?
The main contacts for this study are the Principal Investigators at each site:
Ketan K. Badani, M.D., Columbia University Medical Center, 161 Fort Washington Ave., New York, NY 10032
Ashutosh K. Tewari, M.D., Weill Cornell Medical College, 525 East 68th Street, Starr 900, New York, NY 10021
Contact information
Scientific
Columbia University Medical Center
161 Fort Washington Ave.
New York
10032
United States of America
Study information
| Study design | Interventional prospective single-arm non-randomized multicenter feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Nerve monitoring during robotic radical prostatectomy: a prospective single-arm non-randomized feasibility study |
| Study hypothesis | This feasibility study aims to determine whether the use of nerve monitoring systems can aid in locating the cavernous nerves during robot-assisted radical prostatectomy. |
| Ethics approval(s) | Added as of 05/02/2013: 1. Weill Cornell Medical College IRB, 24th December 2012, Protocol Number 1209013068 2. Columbia University Medical Center IRB, 10th January 2013, Protocol Number IRB-AAAK7758 |
| Condition | Erectile Dysfunction |
| Intervention | The nerves surrounding the prostate will be monitored during the prostatectomy procedure (intraoperatively). Simultaneously, a functional response will be measured with a tissue oxygenation monitor. The nerve mapping procedure is expected to take 10-25 minutes. Subjects will be followed for 6 months following the surgical procedure to monitor adverse events and assess for postoperative erectile function. Joint/Scientific contact details: Ashutosh K. Tewari, M.D. Weill Cornell Medical College 525 East 68th Street, Starr 900 New York, NY 10021 |
| Intervention type | Other |
| Primary outcome measure | Feasibility of nerve monitoring, defined as ability to record compound nerve action potentials from the cavernous nerve during surgery. |
| Secondary outcome measures | 1. Feasibility of functional monitoring, defined as ability to evoke an increase in tissue oxygenation as a result of cavernous nerve stimulation during surgery. 2. Change in preoperative to postoperative erectile function, based on a patient-completed questionnaire (IIEF-5) at three months and six months. |
| Overall study start date | 18/01/2013 |
| Overall study end date | 18/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 30 |
| Participant inclusion criteria | 1. Patient is a male between 18 years and 75 years of age 2. Patient was diagnosed with prostate cancer, undergoing nerve-sparing robotic radical prostatectomy 3. Patient has been informed of the nature of the study, agrees to its provisions and has provided written consent as approved by the Institutional Review Board (IRB) of the respective investigational site 4. Patient is able and willing to comply with all study requirements, including the follow-up evaluations and will return to the investigational site(s) for all required office visits 5. Patient has completed the International Index of Erectile Function (IIEF-5) questionnaire with a score of 17 or higher |
| Participant exclusion criteria | 1. Patient has a history of erectile dysfunction associated with neurologic abnormalities 2. Patient has untreated hypertension (systolic blood pressure > 160mm Hg and/or diastolic blood pressure > 100mm Hg) 3. Patient has any penile anatomical abnormalities (e.g. penile fibrosis or Peyronies disease) 4. Patient has a penile or urinary sphincter implant 5. Patient has a history of prior radiation therapy to the pelvic region 6. Patient is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint 7. Patient with prior pelvic surgery with a potential for clinical interference with the primary study endpoint |
| Recruitment start date | 18/01/2013 |
| Recruitment end date | 18/10/2013 |
Locations
Countries of recruitment
- United States of America
Study participating centre
10032
United States of America
Sponsor information
Industry
710 Medtronic Parkway
Minneapolis
55432
United States of America
| Website | http://www.medtronic.com |
|---|---|
"ROR" |
https://ror.org/00grd1h17 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
