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BackTable / OBGYN / Podcast / Transcript #31

Podcast Transcript: The vNOTES Procedure

with Dr. Jan Baekelandt

In this episode, Dr. Mark Hoffman hosts Dr. Jan Baekelandt, a gynecologic surgeon from Mechelen, Belgium, to discuss a novel gynecologic surgery approach known as vaginal natural orifice transluminal endoscopic surgery (vNOTES). You can read the full transcript below and listen to this episode here on BackTable.com.

Table of Contents

(1) The History of the vNOTES Procedure

(2) vNOTES Surgical Education

(3) Patient & Physician Benefits with vNOTES

(4) vNOTES Surgical Techniques

(5) vNOTES Procedural Standardization

(6) Complications & Considerations for vNOTES Procedures

(7) Adjustments for Endometriosis in vNOTES Procedures

(8) vNOTES Closures: Hernias & Stitches

(9) Best Practices for vNOTES

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The vNOTES Procedure with Dr. Jan Baekelandt on the BackTable OBGYN Podcast)
Ep 31 The vNOTES Procedure with Dr. Jan Baekelandt
00:00 / 01:04

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[Dr. Mark Hoffman]
Welcome back to another episode of BackTable OBGYN. This is your host, Mark Hoffman, and we have Dr. Jan Baekelandt from Belgium here with us today.

[Dr. Jan Baekelandt]
Thank you for having me, Mark.

[Dr. Mark Hoffman]
No, it's our pleasure. We're here to chat about vNOTES. As we do at the beginning of all of our episodes, tell our listeners a little bit about you, where you practice, and how you became interested in vNOTES.

[Dr. Jan Baekelandt]
I'm based in Belgium just north of Brussels. I work in a medium-sized hospital where I work as a gynecologist, but because of our setup in the department, I ended up doing a lot of benign surgery as well. I'm basically a general gyn surgeon with a focus on gynecology. That's Imelda Hospital in Bonheiden. I have an affiliation with the University of Leuven in Belgium as well. I have a little research affiliation with the University of Lund in Sweden, but I mainly work full-time in Imelda in Bonheiden.

[Dr. Mark Hoffman]
Tell us a little bit about what vNOTES is, what exactly that means, and what that surgery is.

(1) The History of the vNOTES Procedure

[Dr. Jan Baekelandt]
vNOTES, it's a complicated term just to say that we're doing laparoscopy through the vagina instead of through the abdominal wall to make it easy. vNOTES stands for Vaginal Natural Orifice Transluminal Endoscopic Surgery. It's an acronym because we operate endoscopically through the lumen of another organ, so not directly through the abdominal wall via natural body orifice.

For gynecology it makes sense to choose the vagina as the natural body orifice of choice to operate through, but there's other types of natural orifice surgery. You can operate transorally, you can operate transanally. The colorectal surgeons do TEO procedures transanally, but for gynecology it makes sense to do our natural orifice surgery transvaginally.

Basically what we do in vNOTES is we do pretty much all gynecological operations by now without making any abdominal wall incisions. The entire procedure is performed transvaginally, and we do this endoscopically like we would operate laparoscopically with the same instruments. We insufflate the abdomen with CO2, but we use all those instruments transvaginally.

[Dr. Mark Hoffman]
It makes sense. In my own training, I'm a mixed surgeon and so I do almost everything laparoscopically. I trained at an institution where they had strong urogynecology, so we didn't get a ton of vaginal surgery. Vaginal surgery in general is one of those things that I think in our training seems to be, we have a harder time teaching that, I think, than we used to. While it's great that we're adding robotic and laparoscopic surgery for our patients, it doesn't seem like we're maintaining the level of vaginal surgery volumes to help a lot of us get comfortable. Personally, it's something I don't do very often, but is that something you've always continued to do? Is it something with vNOTES that you reintroduced into your practice? Talk about how you got interested in vNOTES.

[Dr. Jan Baekelandt]
I've always done vaginal surgery. I was trained in benign vaginal surgery and I had training in shelter surgery, so the radical hysterectomies for cervical cancer to be done transvaginally as well. I've always kept doing vaginal surgery, but vNOTES has now helped to really broaden the indications, whereas in the past we probably did 20, 25 percent of our procedures vaginally, we now do more than 95% of our cases vaginally.

I started vNOTES more than 10 years ago in, I think, 2012, but slowly, step by step, my old endoscopic teacher actually was always in the habit when he did laparoscopic adnexectomy to remove the specimen transvaginally, so he always made a colpotomy. He taught me at the end of a laparoscopic adnexectomy, make a little colpotomy and take the specimen out not to have to make your muscle sheet incision wider in the abdomen.

At the time, I was going through a phase where I was doing single-site surgery. It was 2012, and there was a bit of a hype on single-site surgery. I think it died down a bit because it's technically very, very challenging, and there's not a whole lot of evidence on the benefits for it, but at the time we're doing a lot of single-site surgery. It was with glove ports still back then. It made sense when we did a single-site hysterectomy. You could take the specimen out vaginally; when we say the single-site adnexectomy, we're taking the specimen out via a colpotomy.

Then we started placing that same port. Let's just have a look transvaginally. When we've done that, made that colpotomy, and see what it looks like when we put the port there and then step by step we move forward and start doing more and more steps of the procedure gradually. It wasn't like one day or the other we started performing vNOTES cases.

That's how it grew over time. vNOTES is not a new invention. I think the concept has always been there and other groups in the world have been working on that for a long time as well. I spoke to Leila Metler after a conference and she used to work with Kurt Semm. In Europe, he's considered the father of laparoscopy.

She said that Kurt Semm, when he was starting laparoscopy, and we're talking 40 years ago, and I think he already had that idea that we should move from transabdominal laparoscopy, we should move to moving these instruments transvaginally. They tried it at the time already. That's now 50 years ago, but the instruments weren't right, the light sources weren't strong enough, things weren't there. It's not a new invention, it's just I think instrumentation got better, our light sources got better, our cameras got better, so we got to the point where we can do these things that actually the forefathers of laparoscopy already thought of a very long, long time ago.

[Dr. Mark Hoffman]
I agree. It makes sense. I think there have been plenty of opportunities where I thought I did a TLH on somebody’s uterus and probably could have been in a good TVH case, but I wanted to take a look and see whether there was endo. I want to make sure I get the fallopian tubes or I'm getting the adnexa. It just becomes more challenging with a traditional vaginal hysterectomy.

I think the barriers to many of us getting started, at least. I won't speak for everyone, but for myself, I'm not doing my colpotomies from below. I'm out of practice. I do 99% laparoscopic hysterectomy. So I don't get in from below, I get in from above. Was there any point as you were developing these techniques where you were using a laparoscope but also watching yourself from below to see where you were? I think for me I would have to get a sense of what are my landmarks from below and how does that relate to the landmarks that I'm used to seeing from above?

[Dr. Jan Baekelandt]
We all have a different threshold up to what level we're comfortable with doing. Let's talk hysterectomies, vaginally, and some of us, the ones that have a big prolapse and they're basically hanging out and we feel comfortable doing that and some very skilled vaginal surgeons will take out a one-and-a-half-kilo uterus without prolapse as well. I think we all have a different threshold as to where we decide we're going to do this vaginally or we're going to do this laparoscopic, speaking pre-vNOTES now.

I think many of us don't or didn't do as many vaginal hysterectomies as we technically could because we've gotten spoiled with laparoscopy and robotics. We've got better hemostatic control. We've got these fantastic bipolar instruments and sealing devices that just give us better control and we can see so well what we're doing.

I think that's the main thing is, when we're operating vaginally, a lot of things that could be within our skillset that we could be doing, we don't do because we just feel this little bit more confident in doing it laparoscopically because we know it's dry and we know we've seen everything well and we just feel it's safer for the patient. I think that's why many of us moved away from vaginal surgery for many cases into laparoscopic or even robotic surgery just because of that confidence of visualization and hemostatic control.

That's now what vNOTES brings back. Now we can operate vaginally, which is the least invasive way for the patient, and have our patients recover quicker, but we can still have that hemostatic control and that visualization that we've gotten so spoiled in laparoscopy. I think that's actually what vNOTES brings to the table and helps broaden the indications for vaginal surgery again.

(2) vNOTES Surgical Education

[Dr. Mark Hoffman]
When you were starting out, if you did a case and you felt like, "I just can't figure out what we're doing here," was it a conversion to vaginal hysterectomy? Was it a conversion to laparoscopic hysterectomy? A combination of both? What was the learning curve like for you?

[Dr. Jan Baekelandt]
I think it's hard to compare vNOTES back then and now because it wasn't an established technique, and it was more of a very early on developmental curve where I didn't know, really, what the steps should be, and it wasn't standardized.

[Dr. Mark Hoffman]
Almost "Let's see what we can do."

[Dr. Jan Baekelandt]
Yes. My first hysterectomies took four hours via vNOTES. Now vNOTES hysterectomies are significantly faster than laparoscopic hysterectomies, but at the time it took me a lot longer. We didn't have good ports. We were making the ports ourselves, and now we have standardized ports that are approved for transvaginal use. That sort of made it difficult because we were developing the steps of the procedure as well still. I think by now the procedure is, or it has been for a long time now, it's been established. We know step by step what we should do, which instruments we should use. We know in which order we should be doing the steps. That makes it a lot easier to do it now.

As for the learning curve of an established procedure for somebody who has been trained in the technique and in a proper training setting, I think that also depends on your skill set beforehand. I think one of the weaknesses of vNOTES is that you actually need a double skillset. You need to be confident in basic vaginal surgical skills and you need to be confident in basic laparoscopic skills. I think for most vNOTES procedures, the laparoscopic skills aren't that hard because it's more grab-and-cut surgery. There's not a lot of need for retroperitoneal dissection. I think if you have a basic skillset in vaginal surgery and in laparoscopic surgery, the adoption after proper training is quite quick. Most of the studies say 20 to 30 cases, but it all depends on how confident you are as a surgeon to start.

I think if you have no vaginal skills or no vaginal experience at all, then your learning curve's going to be significantly longer and vice versa, if you are just a vaginal surgeon with no laparoscopic expertise, but I think there's not that many of those around anymore, then it's hard as well. I think with previous training in both, it's quite a short adoption curve.

[Dr. Mark Hoffman]
We've recently gone through the training. We had the folks come down from Applied and do a course. My group is me and another big surgeon and we have two urogynecologists that are in the next office over, next door, not in the next office building, but a close group who worked together often, and we're just getting started. My partner's done a few. I've not even done one yet, so that's why I was excited to get you on. Having a couple MIG surgeons like my partner and I who, honestly, just most of us are not trained in vaginal surgery even though we're supposed to be minimally invasive surgeons and TVH is the least invasive.

Most MIGS fellowships are really laparoscopic robotic fellowships. Our decision to start doing it had to be very systematic and safe, and we had to have the right people in the room. Having commitments from both urogynecologist and MIGS is a great way for both divisions to improve their skillset to be able to do more and everybody wins. It's been nice to have that partnership. It is something that I think vaginal surgery and colpotomy is a bit of a lost art for some of us.

[Dr. Jan Baekelandt]
Yes, it's always a huge advantage if you can start with more than one person in the department, go to the training together, go and observe with somebody with experience together, and then it's just easier to be two to get started, and it's safer for the patient. I think that's exactly what happened over the years is teaching vaginal surgery, A, we're a bit less comfortable doing it because we don't see everything so well, but it's definitely a whole lot more difficult to teach vaginal surgery than to teach laparoscopic surgery because of that visualization issue.

I think with vNOTES now, it actually becomes easier to teach vaginal surgery again because now you can see endoscopically what your assistant or your registrar, whoever your teaching is doing. I'm hoping we're going to broaden the teaching of vaginal surgery again with this.

[Dr. Mark Hoffman]
Yes, when you get in there and see it, it is pretty incredible to watch and you go, "Okay, ah, that makes sense." I think there's going to be some part of that learning curve that is visual cues, and there's certain things I look for. Your brain just notices things when you do hundreds or thousands of cases, and that's something that will just take time from a different approach. I think that's something,it does take a commitment to doing a lot to get good at anything, especially a new surgical approach. Aside from cosmesis, what are the benefits that you've seen and that we're finding out that happen for patients when it comes to vNOTES and maybe also for physicians?

(3) Patient & Physician Benefits with vNOTES

[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 hospitalization 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.

(4) vNOTES Surgical Techniques

[Dr. Mark Hoffman]
Are there specific techniques? I think about the bowel. There's two things, I guess, with the patients that are obese. Getting in certainly is a challenge, but I typically can find ways to get in, things like Palmer's point where there's usually an opportunity to do that and get a pneumoperitoneum, but it's putting a patient upside down. We're not dealing with the same challenges as the bariatric surgeons who are operating in the upper abdomen.

When they are operating, their patients are in reverse Trendelenburg, and all of their bowels go down, and there's decreased pressure on their chest. Those patients, they're not getting as many complaints from the anesthesiologist saying, "I can't breathe this patient," where in laparoscopy for gynecologic surgery, our patients are on their heads and we get them in much T-berg and it's like, "Guys, we can't do this." T-berg is what, as you know, allows us to get the bowel up and out of the pelvis so we can operate safely. Is the degree of Trendelenberg required for vNOTES? Do you still have to put them upside down or are you able to use less Trendelenberg, and then in terms of your peritoneum, is it similar pressure for vNOTES?

[Dr. Jan Baekelandt]
I think on the standard case we use the same degree of Trendelenburg. We use 20, 25 degrees for the endoscopic part. There's a vaginal part as well where the patient's flat, so it's a shorter term of the procedure that they need to be in Trendelenburg. We use the same degree at Trendelenburg. We use lower pressures for vNOTES. Laparoscopically will traditionally work 12 to 15. I think that's very much a local habit, and you could work lower, but that's what we have in our practice. For vNOTES, we stand at work from 8 to 10. I think that's really a collaboration with your anesthesiologist. The more they relax the patient, the lower pressure you can work on.

I think for the very obese patients, we need to give them Trendelenburg as well, and that's always a balance. It's the same with vNOTES. You need to find that balance with your anesthesiologist. The pressures are a bit lower and even then we tend to try and give even lower pressures.

I know for the super-high BMI patients that you can also try and pack the bowels. Vaginally, you have access to put a big swab in and pack the bowel out the way. I think for most cases we try to avoid doing that, and I think we only do it, or I only do it for the very high BMI, because when you pack your bowels, you get more adhesion. We try to avoid that in general, but in those challenging cases, that can help as well.

I think another thing for our endometrial cancer patients, which is typically the very high BMI population, there with vNOTES, we're now doing our sentinel nodes retroperitoneally, and that really helps because as long as we're doing a transvaginally retroperitoneally, but there you don't need any Trendelenberg at all because you're working retroperitoneal, so for that whole part of the procedure where if you're doing it laparoscopically, robotically, your patient's upside down already.

With vNOTES, the patient's flat and it's only for the small endoscopic part of the hysterectomy, which is actually the smaller part of the oncologic procedure that the patient needs to go to in Trendelenburg. The majority of the time, for both sides, the sentinel node, the patient's still flat on the table. I think there's an advantage to that, I think. I want to say for oncology we don't have a lot of evidence yet. That's all still in study settings.

[Dr. Mark Hoffman]
Talk me through that. You're doing this lymph node dissection primarily prior to the hysterectomy.

[Dr. Jan Baekelandt]
Correct. Yes.

[Dr. Mark Hoffman]
You're getting into the retroperitoneal space prior to getting access to the peritoneal space?

[Dr. Jan Baekelandt]
Correct. We inject ICG into the cervix, as you would do for any case. Then we make our weight transvaginally into the retroperitoneal space, actually to the obturator area, to the place where your obturator nerve exits the pelvis at the level of the obturator muscle. Then from there, you start your dissection caudally to cranially down to upwards. Actually, the CO2 does most of the dissection for you. It opens the space up.

I think, besides the fact that it's less invasive in your patient's flat, another advantage, you follow the sentinel node as it is distributed naturally to ICG, you go down to up, whereas if we come laparoscopically from above, we see a green node and you may get excited and say, "Oh, I've got the sentinel node. I'm going to take this one out." You got to be careful not to take the second or the third node because that can be green by the time you come already as well.

Whereas in vNOTES you don't have that risk. You come from the bottom. The first green node you see is automatically the sentinel node. I think that's an advantage that in time with more studies there will be a good place for vNOTES in that group I think.

[Dr. Mark Hoffman]
That's done posteriorly initially with the access for the node dissection is that?

[Dr. Jan Baekelandt]
Now, there's two routes of dissection. Initially we started with a lateral vaginal fornix incision, and then dissected the paravesical space. It works; it's a bit more difficult to teach that access. Now we're actually moving to an anterior vaginal wall incision similar to what you do for an anterior repair and do the dissection from there. We found that it's easier to teach that access to people who don't have as much experience. It's like you're doing an anterior repair, you just go a little bit more lateral and you jump over the arcus tendineus and then you get into the right space paravesically.

[Dr. Mark Hoffman]
It just sounds like you guys are almost, as much as you guys have done, it sounds like it's just the tip of the iceberg right now for what's possible with vNOTES. It sounds like there's a lot of potential.

[Dr. Jan Baekelandt]
I think what we see is we just get different anatomical access now, and the more vNOTES we do, it's a gradual process. It's been over 10 years, I've done over 2,500 cases. It's not something you do in the beginning, but you learn your anatomy in a different way. We actually get to spaces that are difficult to reach laparoscopically in it. We're doing promontofixation via vNOTES, in urogyn as well now. That presacral space, the dissection there, you're seeing structures that I've never seen before laparoscopically just because we're coming in from a different angle. There's definitely a lot of room for development in vNOTES still. I think the most exciting thing is that we see our anatomy transvaginally in a very different way and we get to reach different places.

(5) vNOTES Procedural Standardization

[Dr. Mark Hoffman]
That's something I noticed just even doing just the training and watching videos is again, as I've mentioned earlier, so much of what we do is visual cues like, okay, I need to see the ring, our colpotomy ring as we're pushing up. I need to see that full ring, my posterior dissection inter dissection, always opening all those spaces up, skeletonizing completely, all those things. Big uterus, little uterus, 10 C-sections, doesn't matter. I want these same views, I want these same visual cues so I can understand where I am and where my anatomy is and where I can operate safely. That develops over time.

When you start out, you're taking little bites and as you get further along you're where you can be a little more, I won't say aggressive, but a little bit more comfortable versus where you really need to dial things in. That's something that seems like it just takes years, which is what surgery is, but to develop an entirely new approach to surgery, I think, and I'll again speak for myself, I think it's very intimidating to think about jumping into a new approach like that. Is it something that, are you seeing it being taught in residency? Because again, if we're teaching our residents, our trainees primarily to get comfortable that way, then it becomes a shift in how we practice as opposed to just a few select surgeons around the country.

[Dr. Jan Baekelandt]
You make a very good point. I think the key to a safe implementation is standardization and good teaching. I think that's what we've been trying to focus on most is to really get the technique standardized because the more standardized it is, the less room of variation there is in people in their learning curve and the lower the learning curve's going to be.

Then it's, yes, proper training. I think that's where you mentioned applied medical's helped us a lot with those standardized training courses. We now give exactly the same training courses all over Europe, all over the US, in many other countries, in Australia. It's all standardized content. It's exactly the same presentation, it's exactly the same steps. I think that will really help in keeping our complication rates down.

It is something that worries me because most techniques go through that Gartner cycle, where it takes a long time in the beginning to get the adoption going, and then all of a sudden there's a lot of excitement about the technique and a lot of people get started and not everyone necessarily goes through the right training steps and you get a peak, a lot of cases get done, but then you get to a level where you start seeing the complications coming, and then there's going to be a bit of discredit to the technique because there's going to be reports on complications.

At that point, we're going to need the evidence to prove that in the hands of people who've been properly trained in a standardized way, this is what our complication rates are and they are not higher than they are in standard other techniques. I think that's where the studies are important and where the big complication or case registry is. The international society has a big case registry that's been going since 2015 where a lot of surgeons put their data in and they will be able to see now what actually the complication rates are in the hands of experienced surgeons.

Hopefully, when that dip comes and the complications start coming in, people who haven't gone through the proper training, that's what will help us defend the technique because what we see in the studies is that the complication rates are not higher than in other techniques if not even a bit lower. I think that's the job for science now, to get the technique established.

(6) Complications & Considerations for vNOTES Procedures

[Dr. Mark Hoffman]
What are specific 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 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.

[Dr. Mark Hoffman]
In a vaginal hysterectomy, you're pulling the uterus down, you're compressing that tissue, you are making it more difficult. What kept stressing was pushing that uterus away, push the uterus away, push the uterus away, just like you're doing from below with the colpotomy laparoscopic. You're doing it yourself, and by pushing it away, you're exposing those windows to allow you to visualize those small spaces much more largely.

[Dr. Jan Baekelandt]
Exactly. You have a double flow of carbon dioxide. You have your flow that goes behind the uterus and opens the space in the abdomen. Because you have that empty space there, as you describe it, it's blue or black, the peritoneum, because there's nothing behind, and where your bladder is, it's actually white. There is something behind it. That really helps. If it's one of those uterines that's plastered to your abdominal wall, you can basically do your whole hysterectomy and just leave the uterus hanging on the C-section scar, and at the end, you shave the scar like you shave in endometriosis.

[Dr. Mark Hoffman]
That's the same way we do it laparoscopically. I think many of us, when we first get in there, when you're doing an abdominal hysterectomy in training, that's where you start because that's where your abdominal incision is, is right on top of the mess, is right in the scar. When you get in laparoscopically, and you learn that's the last thing we do. If you see someone start chipping away the scar first, it's like, "Whoa, whoa, whoa, stop. Let's get all the blood supply, and then we have a little dead uterine we can chip away."

Seeing that done from below with the camera was pretty exciting. I thought that was pretty neat.

I think the other thing I was trying to visualize that will take some time is the ureters. Because as we have that ring in, the bladder's anterior to us, the ureters are coming in lateral. The ring, like you said, pushes it out of the way completely. Once you've gotten the uterines first, I imagine the ureters are just now nowhere near, not that you ever ignore them, but they're nowhere near where we're operating once the uterines are taken.

[Dr. Jan Baekelandt]
I think the moment when you're closest to the ureter is when you're coagulating the uterine artery, and that's actually the only moment when you're close to it. If there's no endometriosis and they're in the normal position, the whole bend of the ureter into the bladder is behind the plastic sheet. I think laparoscopically, where we have our ureteric injuries, is not where we go and dissect it to find it. It's usually when we coagulate too close to the vaginal cuff. It's right where the ureter goes into the bladder, the point where you normally don't even dissect it laparoscopically. That area is protected by the alexis sheet. Then the ureter at the level of the uterine artery is lateralized a bit because of the pressure of the ring.

(7) Adjustments for Endometriosis in vNOTES Procedures

[Dr. Mark Hoffman]
You mentioned endometriosis. Talk to me a little bit about how you address the bigger uteruses, we've talked about that a little bit as well, but things like endometriosis or pelvic scarring, how does that change your approach to vNOTES? Are you addressing stage four endo with vNOTES these days? Are there certain cases where you're just like, "This is just not appropriate"? How do you address that?

[Dr. Jan Baekelandt]
What we teach is that endo is a contraindication for vNOTES, and I think there's no need to be dogmatic about vNOTES. We got to think where our patient benefits most of the technique. I think some patients will be better off with vNOTES. Some will be better off with laparoscopy. Some may be better off vaginally. Some may be better off with a robot or an abdominal hysterectomy. I think we need to master the technique so we can tailor them to the patient's needs and not try and squeeze every patient into one little box.

I think there's no reason to do a case where you worry about a posterior colpotomy, whether it's going to be safe or not. If you even have that thought, you should put in the scope and just make sure it's safe. I think from that point of view, we always teach that endometriosis is a contraindication, previous rectal surgery a contraindication. Patients who've had pelvic abscesses, severe PIDs are going to be like a contraindication.

That being said, in research we try and check where the boundaries are and where vNOTES can lead us. I do think with the increased visualization that it gives us, there is, in time, going to be a space for it in more complex procedures. We're starting the radical hysterectomies for cervical cancer now as well. It's an amazing visualization. I've done a number of rectovaginal endometriosis cases, but that's not something that I like to talk about in teaching. It's just a whole lot more challenging, and you need to be very familiar with vNOTES anatomy before you go there. I think the short message is just don't go there. It's not necessary. Just keep it safe and do it laparoscopically.

[Dr. Mark Hoffman]
Not easy laparoscopically either, obviously. Again, as I'm thinking about the anterior challenges, are there potential benefits from below? Maybe, if you can address the nodule and feel it, you can work around it, starting laterally. I can see where in the hands of a skilled vNOTES surgeon who's been doing this a long time are there potential benefits, and that'll be interesting to see develop over time.

[Dr. Jan Baekelandt]
Again, you make a really good point. You see the details very well. That's exactly what we're trying to do now in research is we're trying to do a combined approach where we operate endoscopically, laparoscopically, and vNOTES with two surgeons at the same time for radical endo. Because what is the most difficult is, from above, is the lower part. If the nodule's low down on the rectum, halfway the vagina, it's difficult. If you come from below, that part isn't difficult endoscopically. It gets more difficult as you get higher and higher. If you use the best of both worlds, you can meet each other in the middle. That's what we're trying now. We've just made our first publications on that. I think that's far away from being routine.

[Dr. Mark Hoffman]
I think the opportunity is there. There's definitely times when you want to go, "What's behind there?" If it's clear behind there, then we're good. The potential to do both, and that's something I've thought about as I try to visualize my first cases and visualize how I would do these, popping a scope in from above and watching myself entering in and seeing where I am so I can match my vaginal procedures to my laparoscopic visual cues. Is that something that you recommend?

[Dr. Jan Baekelandt]
I think that's a fantastic way to keep your learning curve safe is any moment where you're doubting your entry, put in a 5 millimeter scope in the umbilicus. The patient won't mind, they'll barely see the scar. You'll see what you're doing and someone can hold the camera from above while you're operating from below, and like that, you safely build up your confidence in your implementation. I think it's a fantastic way to start.

(8) vNOTES Closures: Hernias & Stitches

[Dr. Mark Hoffman]
Let's talk about non-hysterectomy surgeries briefly as we get towards the end here. I think, when doing laparoscopy, we always say fives are free. I hate putting tens in. I never use tens for any of my surgeries, 10 millimeter or larger ports, because I don't want to close fascia. I want to minimize my hernia rates. Single site you mentioned, I am not a fan. I think those 2 to 3 centimeter umbilical incisions have such a high hernia rate. If I'm morcellating, I make a mini-lap Pfannenstiel at the same size and do most of my morcellation that way because the hernia rate from a Pfannenstiel, as obstetrician-gynecologists, we are and should be confident making Pfannenstiel incisions. They're great incisions to close.

I try to avoid larger incisions in the abdomen all the time because of concern for hernia and also just pain. Huge umbilical incisions, patients do not like those, and they don't like their belly buttons to be messed with. When performing a colpotomy for a single-site vaginal incision, what are the hernia rates? I imagine the vaginal hysterectomy closures are the same as a TVH. For a non-hysterectomy case and you're doing a posterior colpotomy and doing a vNOTES for adnexals, what are the risks of vaginal cuff dehiscence or vaginal colpotomy dehiscence or hernia rates for those surgeries?

[Dr. Jan Baekelandt]
For the listeners, for a hysterectomy, we make the same incision and we have the same scar, so that's it. If we're doing vNOTES for other indications, and as I said, we do it for the whole spectrum of gyn procedures, that's where we're going to need evidence to prove that it's safe because with hysterectomy we're reducing our number of scars or a number of incisions. We're taking abdominal incisions away and we're just keeping the vaginal incision.

Now we're in adnexal or myomas or whatever, we're taking the abdominal incision away, but we're replacing it with a different incision. There's your question very correctly, are we not taking any other risks by putting an incision in a different location? I think what we noticed is that those incisions are less painful because the innervation to the vagina is different to the abdominal wall, so there's an advantage.

As far as I know, in the database, there's no dehisces described for a posterior colpotomy. We've had hematomas from the posterior colpotomy, but no dehiscence, as far as I know. I haven't had any. I think the vaginal wall is very forgiving. We know that from obstetrics as well it heals very well and it doesn't get infected as easily. The two big questions that we always get there is one is, what about deliveries, if we do this on young patients for ectopic pregnancy routinely, and two, what about sexual intercourse? Are we causing dyspareunia for these patients?

I think the answer for the first one is that it's a worry in our head because, from endometriosis, many of us are in the habit. If we've had rectovaginal endometriosis, we've shaved the rectum and we've resected part of the vaginal wall. We tell our patients to have a cesarean section and not a vaginal delivery.

I think it's different in vNOTES because we don't have that rectal shaving and we just have a scar in the colpotomy. I think the data that we have on vNOTES is limited. I think there's only one publication we've made. It's from personal experience. We've had lots of deliveries after vNOTES and have not seen any problems. I think scientifically we have data from specimen extraction studies, people who do adnexectomies and take the specimen out through the colpotomy.

Those data also suggest that that incision is safe for a vaginal delivery after that. I think that's not an issue that I worry about. We do it on our young patients. I routinely do all the ectopic pregnancies that way, and we let them deliver vaginally, and our C-section rates or our tear rates are not higher.

I think dyspareunia is a much more important question to look at. There we need to have big data. There's studies ongoing on that. We have data from the RCTs that we've done, or an RCT on annexectomy that don't show any higher problem rates. Those are small, small data up to now. Again, very technical. I'm going to try and explain it anyway. I think it's really important where you place that incision. If you make your posterior colpotomy incision on the same location where you would do it for a hysterectomy, the problem then becomes that your vaginal mucosa retracts a bit and when you close it afterwards, you don't have a lot of mucosa between the cervix and your incision to close.

[Dr. Mark Hoffman]
Right. I imagine if you're right up next to the uterus, which is where you want to be for a hysterectomy, you don't have much with which to close.

[Dr. Jan Baekelandt]
Exactly. What you do then is you actually pull your uterus into the posterior fornix. You pull your uterus backwards, and then you don't have a posterior fornix anymore, which could be a cause for dyspareunia. That's something that I think is really an important issue to teach is to where to place that incision. For a non-hysterectomy case, your posterior colpotomy incision must be at least 1.5, 2 centimeters lower, closer to the rectum, but then your dissection has to be upwards. Then you have a lot of space to suture. You need to retrain that colpotomy from people who are used to making it for hysterectomy, you need to make it in a slightly different location. Then I think, from my experience, it's not a problem. I don't see any dyspareunia problems with that, but I make my incisions very low, far away from the cervix.

[Dr. Mark Hoffman]
I've seen folks that do colpotomy for tissue extraction for myomectomies, patients who are going to get pregnant or at least planning on getting pregnant who are wanting to get smaller abdominal incisions, so robotic or laparoscopic. Myomectomies don't want to make that big incision, but you don't have colpotomy or vaginal incisions from a hysterectomy, but they're making a posterior colpotomy incision and it seems like it works pretty well. How are you closing those? Are you just doing a barbed suture single layer? Are you doing it in two layers? How do you close those incisions?

[Dr. Jan Baekelandt]
Single-layer, but probably whichever suture is probably not that relevant there. We do single layers. I try to approximate peritoneum and vaginal mucosa together because it's that dissection space between the peritoneum and the mucosa is where your oozing is, where your risk for hematomas is. If you can compress those two layers together, then-- but I think whether you do that in a running suture or in a separate figure of eights probably doesn't matter. I think it's very forgiving there.

(9) Best Practices for vNOTES

[Dr. Mark Hoffman]
I feel like I could ask another a hundred questions about this. I know you're a busy surgeon and we're grateful you spent time. Any last thoughts for our listeners on vNOTES on things that they should think about when introducing this into their surgical practices?

[Dr. Jan Baekelandt]
Yes, I think go through the proper training pathways. They're available and they're available all over the world. I think you have listeners all over the world. These courses are being given in the same way everywhere. What worries me most is people watching a YouTube video and thinking, "I can do this." It's not difficult surgery, but as with any technique, there's just lots of little tips and tricks. Surgery's always in the detail, and if somebody explains all those details, it will just be so much safer for your introduction.

Then a second thing, I think once you get started, is to start with the very, very easy cases. If you start with very easy cases, then you can gradually build it up. It will just be nicer. It would be safer for your patient, it'd be nicer for your whole team because it's a new procedure, and not just for yourself, but for your whole OR team, and you have to get them involved in the process. You have your scrub nurses and your anesthesiologists, and you have to get everyone involved in the process.

If you can then make sure that your first cases go smoothly, you keep everybody motivated and it's a safe and easy implementation. I think the problem we see is people who try to run before they can walk, and they start with a 800-gram uterus. That's not the way to start a new technique.

[Dr. Mark Hoffman]
I think that's not different from what we see with our colleagues, whether they're trying to start laparoscopic surgery or jumping in, doing two to three hysterectomies per year, and think, "Oh, we'll go ahead and just do this one-kilo case." It's like, "Make sure I'm around for that one."

I think, like anything, with surgery, repetition, repetition, repetition is everything. Minimize variability. It is getting as many of these as you can so you can start to see the subtle differences and nuances, if anything, but yes, it sounds like, though it's a new approach, old adages are true, and it's all about developing techniques. Start easy and work your way up, and give yourself the space and patience, and your whole team the time and energy, but starting with that training.

I can say from personal experience, having done the training, it's done really well. It definitely was important for us to do that, and as we started doing them, where we are now, I think the reason we're going to have good outcomes is because of the training and because of the team that we built and the number of surgeons who are committed to helping all of us and all of us get better.

Actually, one last question. I just thought that this is where we're wrapping up. Robotic surgery, single-site, and anything, are there any examples that you've used a robot with this stuff, that you're using any additional besides straight laparoscopy? I assume that's traditional, what you've done. Is that something that's being done, is being talked about, using vNOTES in combination with robotic surgery?

[Dr. Jan Baekelandt]
Yes. There's a whole big topic and I think we're going to do a whole podcast session about that, but I'll keep it brief.

[Dr. Mark Hoffman]
We'll have you back.

[Dr. Jan Baekelandt]
Inviting myself is what I'm doing now. With the current existing systems, I tried a couple of years ago, and looked with the da Vinci Xi whether we could do vNOTES. We did 30 or 40 cases, and it works. It's just there's no benefit. It's making life difficult. It's not made for it and there's no space for the four arms. You can do it with three, but there's a lot of arm collisions. It just adds a lot of extra time to the surgery and no benefit.

I think there, no, but I think there's a lot of development in robotics and there's a lot of new systems coming. Single-site system, you have the SP system from Intuitive. I work a bit with Momentis there. They're developing a robot for transvaginal use, specifically for vNOTES, and actually, they're on the market. I'm in Europe. It's not on the market here, but it is on the market in the US.

[Dr. Mark Hoffman]
Is that the one that goes behind the uterus and looks up laparoscopically?

[Dr. Jan Baekelandt]
And retroflexes.

[Dr. Mark Hoffman]
Yes, yes, yes. I assume that.

[Dr. Jan Baekelandt]
Again, I think we're going to need studies, we're going to need evidence, and it's going to be hard. vNOTES, endoscopically, is not that difficult. Our procedure times are getting so short compared to laparoscopy that to prove a robotic benefit to that is going to take time, but I think it's going to be the same as with robotics transabdominally. We also don't have a lot of evidence yet, but there is a group of surgeons that feels more comfortable doing it that way, and then that's absolutely great because that's better for the patient. There'll be a group of surgeons that feels more confident doing it endoscopically, laparoscopically, or via vNOTES.

I think whichever technique gives you the most confidence to do it safely for your patient is the one that you should choose. I think there'll be a place for it in time, for sure, with developments of more and more new robotic systems. It will come, but I think at the moment, yes, it's for a specific niche.

[Dr. Mark Hoffman]
I keep saying the last question, but as you say something, a new idea pops in my head, but maybe this will be the last question. We'll see. Ergonomically, it seems like, I've talked to general surgeons about this, who, if they're doing upper abdominal surgery, they're standing in between their legs, they're operating the normal-- standing up straight. Laparoscopy in the pelvis, we're standing at an angle, we're leaning over no matter how well we set ourselves up. Are you sitting for these cases? Are you comfortable? It's just like you're just sitting at a desk, like ergonomically more comfortable than in traditional laparoscopy?

[Dr. Jan Baekelandt]
It's a big difference. I operate two and a half to three days a week. If you do a lot of laparoscopy, it takes a strain on your shoulders and on your neck. With vNOTES, A, I said our surgical times are shorter. We're taking, in the studies, half an hour off our hysterectomy times with vNOTES, so your procedure's shorter, but you're also sitting. You're not standing up, and you're sitting with the screen straight in front of you. Your shoulders are close to you and you're more comfortable, so it definitely makes a big difference.

[Dr. Mark Hoffman]
I have no problem being more comfortable at the end of a long day in the OR. My shoulders are definitely letting me know, more and more these days, that they would be happy if I found a more ergonomic way for me to do these things.

We are so grateful that you were able to join us today. That was fascinating, and I look forward to seeing all the great work that you'll continue to do.

Podcast Contributors

Dr. Jan Baekelandt discusses The vNOTES Procedure on the BackTable 31 Podcast

Dr. Jan Baekelandt

Dr. Jan Baekelandt is a gynecologic surgeon in Mechelen, Belgium.

Dr. Mark Hoffman discusses The vNOTES Procedure on the BackTable 31 Podcast

Dr. Mark Hoffman

Dr. Mark Hoffman is a minimally invasive gynecologic surgeon at the University of Kentucky.

Cite This Podcast

BackTable, LLC (Producer). (2023, August 31). Ep. 31 – The vNOTES Procedure [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.

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