Dr. Behfar Ehdaie

Yeah, so as we think about clinically integrated trials, our outcome measures need to be something we record as part of clinical care. Nothing separate. Our eligibility criteria should be very similar to the patients we treat every day. In this specific trial that you're speaking about, which was our umbrella trial and modification of radical prostatectomy, You're right.

We were looking at modifications that surgeons do every day in the operating room, but we don't record. Oftentimes when we do, we do a before and after study and say, I've done this 200 ways this way. Before I did it a different way. Here's my retrospective study outcomes. Well, we decided let's ask those questions prospectively. And the modifications had to be decided upon by the group.

We were looking at modifications that surgeons do every day in the operating room, but we don't record. Oftentimes when we do, we do a before and after study and say, I've done this 200 ways this way. Before I did it a different way. Here's my retrospective study outcomes. Well, we decided let's ask those questions prospectively. And the modifications had to be decided upon by the group.

We were looking at modifications that surgeons do every day in the operating room, but we don't record. Oftentimes when we do, we do a before and after study and say, I've done this 200 ways this way. Before I did it a different way. Here's my retrospective study outcomes. Well, we decided let's ask those questions prospectively. And the modifications had to be decided upon by the group.

Oftentimes, a modification that six, seven, eight other surgeons also agree on incorporating is probably not a large deviation from the intervention itself. You know, we're not telling radical prostatectomists to do focal therapy as a randomized arm. We're asking them, for example, to do retia sparing on cases or not do retia sparing.

Oftentimes, a modification that six, seven, eight other surgeons also agree on incorporating is probably not a large deviation from the intervention itself. You know, we're not telling radical prostatectomists to do focal therapy as a randomized arm. We're asking them, for example, to do retia sparing on cases or not do retia sparing.

Oftentimes, a modification that six, seven, eight other surgeons also agree on incorporating is probably not a large deviation from the intervention itself. You know, we're not telling radical prostatectomists to do focal therapy as a randomized arm. We're asking them, for example, to do retia sparing on cases or not do retia sparing.

Or like you mentioned, when we close the incision port, instead of closing it vertically, close it horizontally to see if we can reduce infection rate. So these modifications, when you get to the point of asking a group, again, getting the key stakeholders, organically become modifications that can be incorporated and can be seen as standard of care.

Or like you mentioned, when we close the incision port, instead of closing it vertically, close it horizontally to see if we can reduce infection rate. So these modifications, when you get to the point of asking a group, again, getting the key stakeholders, organically become modifications that can be incorporated and can be seen as standard of care.

Or like you mentioned, when we close the incision port, instead of closing it vertically, close it horizontally to see if we can reduce infection rate. So these modifications, when you get to the point of asking a group, again, getting the key stakeholders, organically become modifications that can be incorporated and can be seen as standard of care.

Having said that, most of these trials are not comparing A versus B with both our experimental or intervention trials.

Having said that, most of these trials are not comparing A versus B with both our experimental or intervention trials.

Having said that, most of these trials are not comparing A versus B with both our experimental or intervention trials.

We're always comparing to a standard, and that standard is what we've been doing, a standard of care, with a slight incremental improvement that we perceive but hasn't been proven yet, which really brought us to the second trial that we really enrolled in, which is our hernia trial. So, again, the idea sprouted.

We're always comparing to a standard, and that standard is what we've been doing, a standard of care, with a slight incremental improvement that we perceive but hasn't been proven yet, which really brought us to the second trial that we really enrolled in, which is our hernia trial. So, again, the idea sprouted.

We're always comparing to a standard, and that standard is what we've been doing, a standard of care, with a slight incremental improvement that we perceive but hasn't been proven yet, which really brought us to the second trial that we really enrolled in, which is our hernia trial. So, again, the idea sprouted.

The importance of the idea was a retrospective paper we did in SEER in which we found that approximately... 7% of patients who get a radical prostatectomy in the United States have a subsequent hernia operation, umbilical hernia incision repair within three years of the operation.

The importance of the idea was a retrospective paper we did in SEER in which we found that approximately... 7% of patients who get a radical prostatectomy in the United States have a subsequent hernia operation, umbilical hernia incision repair within three years of the operation.

The importance of the idea was a retrospective paper we did in SEER in which we found that approximately... 7% of patients who get a radical prostatectomy in the United States have a subsequent hernia operation, umbilical hernia incision repair within three years of the operation.

So almost one out of 12 men getting a radical prostatectomy and go on to get a secondary surgery due to our intervention. So we asked the simple question, can we improve that? Well, the literature provides some guidance. So we knew the question was important to reduce even 30%.