vNOTES Patient Selection, Contraindications & Complications

[Dr. Jan Baekelandt]
The obvious thing is we're making no abdominal incisions. Aesthetically, I think for us as surgeons, that's a minor argument. I think we deal with a special population. We're just dealing with women, not with men. I think in our population, it's more important than in the general population. We notice, amongst patients as a man, I have a knee injury and I'm in the locker room playing basketball and I can show my big scars to my mates, I feel like a big man, but for the female population, it is more important not to have any scars. I think for us as surgeons, that's not a major argument when we're actually deciding which procedure to choose, and we want to choose the safest procedure for our patient.

I think we've done two randomized controlled trials comparing vNOTES with laparoscopy, one, the HALON trial for hysterectomy, and a second one, NOTABLE trial for adnexectomy, where we did in a single center blinded setting, a non-inferiority blinded setting. We compared the two techniques, and the clear significant outcomes were, one, it was a non-inferiority trial, so it was non-inferior. We had no more conversions in either group, but I think the more important ones was pain. The postoperative pain scores were lower in the vNOTES groups and the use of analgesia was lower.

We had shorter vNOTES recovery time, and one of the outcomes was discharge within 12 hours, and that was significantly higher in the vNOTES group than in the laparoscopy group. We had lower complication rates in the hysterectomy group as well, but that's single surgeon, single sitting. We're looking now at, or we're starting a multicenter randomized controlled trial comparing vNOTES hysterectomy techniques, so laparoscopic hysterectomy, vNOTES hysterectomy, and vaginal hysterectomy. There's no good comparison at the moment between vaginal hysterectomy and vNOTES.

[Dr. Mark Hoffman]
It doesn't sound like an easy study to do, first of all, just being big and multi-center. Luckily, vaginal hysterectomy and laparoscopic hysterectomies are safe surgeries and have traditionally pretty low complication rates. I imagine non-inferiority is probably easier to do than true benefit, but the fact that they're all pretty safe surgeries is a great thing. To be able to introduce a new technique and show that it's also providing, it's as safe and also potentially providing some improvements like decreased pain is pretty amazing for a comparison against already pretty safe and well-tolerated procedures. That's exciting.

There are things I think about with improvements, though. In Kentucky, where I work, we have a large percentage of obese patients, probably a lot more so than in Europe. Are there benefits outside of pain and hospital length of stay for vNOTES? I think there are patients that I just cannot operate on laparoscopically for hysterectomy because their BMI is high enough that I can't get them in steep enough T-berg to see into their pelvis. Is that an opportunity, or is that still a limitation for vNOTES?

[Dr. Jan Baekelandt]
Yes, I think you make a good point. I think there's just three groups of patients that benefit specifically from vNOTES, and the obese is one of them. I'll elaborate just now. I think the other group is the patients with previous abdominal surgery, patients who have had multiple laparotomies with mesogastric low abdominal adhesions. When you address those laparoscopically, you start with an adhesiolysis and when you do them endoscopically transvaginally via vNOTES, you can often stay below the adhesions and don't need to do an adhesiolysis. That's a group that definitely benefits.

The second group is a patient with a very large uterus. When we do a hysterectomy for a large uterus laparoscopically, we're using a manipulator. We're pushing the uterus upwards to be away from the ureters. That way we're always pushing the uterus towards the camera, and we have to put our camera higher and higher or more lateral. That's a group where vNOTES is particularly good because with vNOTES you're pushing the specimen away from your camera, you're pushing it into the abdomen, and you're actually not working in the direction of your dangerous structures of the ureter and the bladder. You're working away from them. You automatically have your blood supply at the start of the procedure as well. I think that's where you gain most with vNOTES is on those large uteri.

The third group that benefits a lot is the obese patients. Any procedure or with any technique is more challenging as the BMI goes up. It's the same for vNOTES. The vNOTES hysterectomy on a BMI 50 is a lot harder than one on a BMI 25 for sure, but I think the degree of difficulty doesn't go up as much as it does laparoscopically. If you're operating a very high BMI patient laparoscopically or robotically, your distance to your specimen increases with the BMI. You're using endoscopic instruments, but your pivot point gets a lot further away from your specimen and laparoscopy, and that makes it hard.

In vNOTES the abdominal wall is as obese in the patient, but the distance to your specimen vaginally doesn't increase. There's more abdominal fat, and it's going to be in the way, and it's going to be harder with Trendelenburg, but at least your distance to your specimen from your instrument to the uterus transvaginally doesn't increase.

Patients don't tend to have as much adipose tissue vaginally as they have in the abdominal wall. I think if I have a very obese patient-- and you're right, we don't have those super-high BMI, 70 plus. I don't see those. With experience up to 55, 57, I notice that it's easier to operate them via vNOTES than laparoscopically. I never doubt that I have a high-BMI patient. I notice there's groups in the US that have experience with BMI 70 plus and say the same. In those patients they prefer to do vNOTES than laparoscopy, but of course it gets more difficult. It always does.

[Dr. Mark Hoffman]
What are specific vNOTES complications? What are the complications that are unique to vNOTES? Because again, as I think about going through and doing a hysterectomy laparoscopically, I have the same steps. Every case is the same. Again, it doesn't matter on the uterus, it's just like always the same steps, just different amounts of time spent on each one, but with my uterines, taking them more medially, so if it retracts, I've got a nice pedicle. How do you chase a pedicle laterally outside of the ring and those kinds of things? What are specific challenges and complications that one can expect when starting to introduce vNOTES into your practice?

[Dr. Jan Baekelandt]
I think what you say on the uterine arteries is really important there because obviously, bleeding is our most common vNOTES complication in all procedures we do, all techniques. I think specifically to vNOTES, if we're talking hysterectomy, now if you take uterine artery, you get it right at the start of the case, not at the end of the case, and without going retroperitoneal, so that's a benefit.

A downside is that if you don't seal it properly and you cut it, it will retract behind the Alexis ring, and then it becomes more challenging to catch it. Now, if that happens, we take the ring out, you pull on your uterosacral pedicle, and then you can grab it vaginally, but that's a moment where you need some vaginal experience to grab that. I think the main thing we always stress in teaching is that just take your time for that uterine artery and don't just take it once with the sealing device and be confident with it.

It will work 9 out of 10 or 98 out of 100, but there will be a couple of cases on a larger uterus where you're putting more traction where that is not enough of a seal. Take it a couple of times next to each other with your sealing device or with a standard bipolar before you cut it. Take your time on that uterine artery, and then it's never an issue. Also, once you've done that, the rest of your hemostasis is easier. Then you can speed up and don't need to worry so much.

[Dr. Mark Hoffman]
I imagine the ring provides some hemostasis, a little bit on the little stuff, too. When I think about our transvaginal tissue extraction, when we put the ring in, put the bag in, it's putting significant pressure on the vaginal cuff for the time that we're doing our morcellation. When you go back up above and close the cut, there's been somebody holding pressure circumferentially for whether it's 10 minutes or an hour and a half, depending on the uterus, and you're providing some hemostasis. Does the ring itself provide some additional hemostasis and vNOTES in the same way?

[Dr. Jan Baekelandt]
It does. It's exactly like you said. It compresses, but once you take it off, you have to check your hemostasis. Again, I think a second thing that it does is it lateralizes your urogen. We did some cadaver study to look at that, but because that Alexis ring pushes on the pelvic sidewall, it automatically pushes your ureter more lateral. We saw when we did the dissection without the Alexis in place, we had two inches between the pelvic sidewall and then a natural position of the ureter, and where we put the ring in place, that reduced to an inch. It lateralizes your ureter about an inch, and that, I think, helps.

I think that's what we've seen in the studies that have been published so far is that we have less ureteric injuries than in laparoscopic surgery or in laparoscopic hysterectomy, but we have a slightly higher rate of cystotomy. I think it makes sense because you're doing that dissection vaginally.

[Dr. Mark Hoffman]
That's what we all fear. That's what we all fear is doing that colpotomy is getting in from above, or from below. I think that's the kind of thing that, with time, I think that rate will go down, but you just have to understand there are trade-offs.

[Dr. Jan Baekelandt]
That is the one to be aware of. I think it's logical that our cystotomy rates are a little bit higher in the vNOTES studies than in the conventional vaginal hysterectomy studies because we're tackling more challenging cases. We're doing bigger uterine, and bigger myomas and multiple C-sections. I think what helps there is, but this is now very technical, but I'll stay brief, is that instead of making your colpotomy as you do on a vaginal hysterectomy, just with cold scissors and a forceps is to actually make it endoscopically, so you can place your inner Alexis ring in a way that it is between the vaginal mucosa and the still closed peritoneum. Then you can make your dissection for your anterior colpotomy with endoscopic instruments. I think with that, we now see that our cystotomy rates are going down.

[Dr. Mark Hoffman]
I saw that on a video because I think about patients who had two or three or four C-sections, and you know there's going to be some scarring in the lower uterine segment, but there's always that safe space between the scar from the cesarean and your uterine arteries. Because most of us, if we're doing C-sections, and I haven't done one in a while, but I'm pretty sure they still try to avoid the uterine arteries.

When they're closing your hysterotomy and the C-section and scarring, there's always that little window, that little safe window just anteriorly. Even if your uterus is plastered to the anterior abdominal wall, dissect posteriorly, jump over the uterines, and just bluntly just push whatever's there and just isolate your uterines. I watched a video as part of the training and could see it vaginally where they placed the ring, not, because they hadn't made the colpotomy yet, placed it up against that C-section scar, and blew it up.

You could see that black dark because it was insufflated from the posterior colpotomy, so that black, thin, single layer of peritoneum, you could see your uterines that you'd already gotten or were going to get on a lateral aspect, but just interior to that, I could see the back side of that, and it was a very light bulb moment for me. I was like, "There it is. That's the spot. I've found it."

On the other side, it took me seeing it to realize what it was, and all of a sudden, you go, "Okay, officially, I get it now." I can imagine how once you find those opportunities because there's, like any surgery, where are your safe spaces? Where are your opportunities for success? I saw that and went, "Okay, now that makes so much more sense. There's a completely safe space. I can just see it clear as day." Again, that was a moment for me where I thought vNOTES was pretty cool.

[Dr. Jan Baekelandt]
You describe it beautifully. I can't describe it any nicer than you did, but that was exactly what I felt the very first time I tried it. Because I thought, "How can I try and reduce this rate? Can I place the ring," and tried all sorts of setups. The first time we put the ring that way and saw that, it was like now we can do these difficult colostomies, where in a normal vaginal hysterectomy, you're stuck. You can make your posterior colpotomy tie off these vesicles, but if you can't make an anterior colpotomy, you have to convert your laparoscopy.