Clinical trial: NCT03630393
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Options Are There?

If you agree to take part in this study, there may or may not be direct medical benefit to you.  
While doctors hope that treatment with a lower air pressure of 6 mmHg will be more beneficial, as compared to the usual air pressure of 15 mmHg, there is no proof of this.  We do know that the information from this study will help doctors learn more about using lower air pressures during robotic prostate removal surgery. This information could help future patients with your condition.

Instead of being in this study, you have these options:
Regular treatment with your doctor, which could include either of the air pressures during surgery (6 mmHg or 15 mmHg)
Please talk to your doctor about these and other options.
Clinical trial: NCT03630393
Section: Confidentiality
Subsections: What Information Will Be Collected From Me For Use In The Study?|What About Confidentiality?

The medical information that will be collected from you if you take part in this study includes:  
Information obtained from procedures used to determine your eligibility to take part
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in the research study, including a routine medical history and physical exam.  
  
Information that is created or collected from you during your participation in the
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study, including your over-all medical condition, the results of your surgery, blood tests, and study questionnaires.  
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Information contained in your underlying medical records related to your medical history and treatment prior to this study
The above information may identify you by name, address, telephone number, social security nmber, health plan number, study number, date of birth, dates relating to various medical procedures, or other identifying information.

If you sign this form and take part in this study, the study staff will be authorized to use the information described above to carry out the purposes of the research study.  The study staff will also be authorized to disclose the information described above to all of the following parties involved in the research study:
Organizations that may inspect and/or copy your research records for quality assurance and data analysis include groups such as:
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•
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OhioHealth Institutional Review Board (IRB) Funding Entity (CONMED Corporation)
The U.S. Food and Drug Administration (FDA) and other government agencies. The Department of Health and Human Services Office of Human Subject Research Protections The Centers for Medicare and Medicaid Services (CMS)
The financial agent for CMS
OhioHealth Research and Innovation Institute Office of Regulatory Compliance
Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law.   Once your information is disclosed to the study funding entity, the IRB or the government agencies described above, there is a potential that your medical information will be re-disclosed and will no longer be protected by federal privacy regulations.  
If we publish the information we learn from this study in a medical journal, you will not be identified by name or in any other way.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results.  You can search this Web site at any time.
Clinical trial: NCT03630393
Section: Duration of Study Involvement
Subsections: How Long Will I Be In The Study?

You will be in the study for 3 months.  
You can stop being a part of this study at any time. However, if you decide to stop being in the study, please talk to the study doctor first.
Clinical trial: NCT03630393
Section: Participant's Rights
Subsections: Do I Have The Right To Decline Authorization?|How Long Will My Authorization Remain In Effect?|What Are My Rights As A Participant?

You have the right to decline to sign this authorization to use/disclose your medical information.  
If you decline, you will not be able to take part in this research study.  Except as described herein, if you decline to sign this authorization, your rights concerning treatment, payment for  
  
services, enrollment in a health plan or eligibility for benefits will not be affected.

There is no date at which your permission ends. Your information will be used indefinitely. This is because the information used and created during the study may be analyzed for many years, and it is not possible to know when this will be complete.

Your doctor has answered your questions.  You can ask your doctor questions at any time.  
Taking part in this study is voluntary. You may choose not to take part or you may leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled.  
We will tell you about important new information that may affect your health, welfare and willingness to stay in this study.
Clinical trial: NCT03630393
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of The Study?|What If An Injury Occurs Because Of The Study Treatment? Ohealth Responsibility:

There are no physical risks expected to be associated with the use of less air pressure (6mmHg versus 15mmHg) during surgery.  
There may be side effects that we cannot predict. Many of these side effects are often manageable and reversible.  You will be observed for side effects and all medically appropriate efforts will be made to prevent and/or control them.  If there are side effects that cannot be controlled or reversed, they may result in serious injury or death.  
YOU SHOULD REPORT ANY OF THESE PROBLEMS TO THE STUDY DOCTOR
IMMEDIATELY SO THAT APPROPRIATE CARE CAN BE GIVEN.  SIDE EFFECTS
OTHER THAN THOSE LISTED HERE MAY ALSO OCCUR. TALK TO THE STUDY
DOCTOR ABOUT ANY SIDE EFFECT THAT SEEMS UNUSUAL OR THAT IS ESPECIALLY BOTHERSOME TO YOU.

In the case of injury or illness resulting from this study, emergency medical treatment will be provided. You or your insurance company will be financially responsible for this emergency medical treatment, continuing medical care and/or hospitalization. OhioHealth Corporation has no funds set aside to compensate you in the event of injury or illness.
Clinical trial: NCT03630393
Section: Procedures
Subsections: What Will Happen In The Study?

You will be "randomized" into one of the study groups described below.  Randomization means that you are put into a group by chance.  It is like flipping a coin.  A computer will decide which group you are in.   Neither you nor the study doctor will choose what group you will be in.  You will have an equal chance of being placed in either group. Randomization will occur at the time of surgery when the randomization envelope is opened by the Clinical Research Coordinator. Control Group: 15 mmHg air pressure Study Group: 6 mmHg air pressure All patients will follow routine care with the surgeon, Dr. Abaza.  The only other study activities include questionnaires, as described below.  
| Study Calendar.                              | First    | Surgery/   | Days 1-2   | 1-Week   | 1-Month   | 3-Month   |
|----------------------------------------------|----------|------------|------------|----------|-----------|-----------|
| Office                                       | Hospital | (at home)  | Visit      | Visit    | Visit     |           |
| Visit                                        | Stay     |            |            |          |           |           |
| Consent                                      | x        |            |            |          |           |           |
| Randomization                                | X        |            |            |          |           |           |
| Office Visit                                 | x        | x          | x          | x        |           |           |
| Post-Operative                               | x        |            |            |          |           |           |
| Questionnaire                                |          |            |            |          |           |           |
| Post-Discharge                               | x        |            |            |          |           |           |
| Questionnaire                                |          |            |            |          |           |           |
| Follow-Up                                    | x        | x          | x          |          |           |           |
| Questionnaire                                |          |            |            |          |           |           |
| Quality of Recovery                          | x        |            |            |          |           |           |
| Questionnaire                                |          |            |            |          |           |           |
| Phone Calls                                  | x        |            |            |          |           |           |
| *Randomization will occur at time of surgery |          |            |            |          |           |           |  
Post-Operative Questionnaire:  
We will ask you to rate your pain every 2 hours while you are in the hospital, and O
right before you are discharged (sent home).  We will ask about pain in 5 different body locations, and ask you to rate your pain on a scale of 0 (no pain) to 10 (worst possible pain).  
We will ask you to rate your pain a maximum of 13 times while you are in the o hospital, depending on when you are sent home and if you are awake or not. We will also ask whether you were able to pass gas in the hospital prior to being sent O
home.  We will ask you this a maximum of 4 times until you are able to pass gas.  
Post-Discharge Questionnaire:
If you are discharged the same day as your surgery, we will call to get your last pain o scores the next day.  
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.  
If you are unable to pass gas while in the hospital, we will ask you about this as well o when we call to ask about your pain.  
If you are still unable to pass gas the day after you are sent home, we will call and ask O
again the next day as well, and the next day, until you are able to pass gas.  
Follow-Up Questionnaire:
At your regular follow-up visits with your doctor, we will ask questions related to O
your medications, pain, and weakness, which should take only a few minutes to complete.  
This questionnaire will be completed a total of 3 times at each follow-up visit: 1 o week, 1 month, and 3 months.  
Quality of Recovery (QoR)-15 Questionnaire:
At your regular follow-up visit with your doctor at 1 week, we will ask questions O
related to your quality of life after surgery, which should take only a few minutes to complete.  
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Clinical trial: NCT03630393
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this study is to compare different air pressures used during surgery to create a
"pneumoperitoneum," which is an air bubble in the peritoneal cavity (abdomen, or belly area) to allow for the surgeon to have space and see to perform your prostate removal surgery.  We will be comparing two different pressures, 6 mmHg and 15 mmHg, to see if the procedure can be performed using less air pressure.
Clinical trial: NCT03630393
Section: Withdrawal from Study
Subsections: Can I Withdraw My Authorization?

You may withdraw your authorization at any time by sending a written request to the Principal Investigator at:
Ronney Abaza, MD, FACS
OhioHealth Dublin Methodist Hospital 7450 Hospital Drive, Suite \#300, Dublin, OH 43016 If you withdraw your authorization:  
Your participation in the study will end
.  
The study staff will stop collecting your medical information
Your medical information that has already been used and disclosed prior to withdrawing your authorization remains a part of the research study data.  
While the research study is in progress, your access to your study records will be temporarily suspended. Afterwards, you have the right to see and copy the medical information collected from you in the course of the study, for as long as that information is maintained by the study staff and other entities subject to federal privacy regulations.