, Director of the Division of Minimally Invasive Gynecologic Surgery at Brigham and Women’s Hospital in Boston and professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School.

Jon I. Einarsson, MD, PhD, MPH

, we convened a group of gynecologic surgeons to 

 using vaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologic surgery.

vNOTES is in some respects a hybrid between NOTES and single port surgery, both of which became very popular 10 to 15 years ago.

NOTES procedures were performed through the vagina, stomach, and rectum and mostly by general surgeons. 

A lot of innovation took place with several novel instruments that had been developed for suturing and retraction. However, enthusiasm gradually waned becasue of several factors; these included reimbursement issues because insurance companies considered the approach experimental. Additionally, surgeries were prolonged, and technically demanding and required extra equipment that wasn’t always available.

Single port surgery experienced a similar evolution, with initial enthusiasm, then a decline, although there are still surgeons who offer this procedure to patients. Single port surgery using traditional laparoscopic instruments is challenging because of instrument clashing, and patient outcomes did not seem to differ from those of traditional laparoscopic surgery.

 Robotics companies have developed solutions that enable surgeons to triangulate instruments with greater ease, so perhaps we will see a resurgence in enthusiasm for single port surgery.

I jumped on the single port/NOTES bandwagon several years ago and developed a procedure called orifice assisted single incision surgery (OASIS).

 This was an attempt to decouple the optical access from the operating instruments. It held some promise initially but proved to be logistically difficult because of a lack of appropriate equipment and, more importantly, no apparent difference in patient outcomes. I therefore jumped off the single port/NOTES bandwagon shortly thereafter.

The reality is that traditional laparoscopic surgery provides excellent outcomes, great surgical exposure, and the flexibility to tackle almost any clinical situation. As such it is a high bar to overcome—vNOTES is essentially single port vaginal surgery. Its advantage is that vaginal access is larger than with a traditional single port incision and therefore instruments can be spaced farther apart, reducing instrument clashing. vNOTES also provides an excellent natural orifice extraction port when dealing with a fibroid uterus or adnexal masses. The absence of a 2.5- to 3-cm umbilical incision in vNOTES is also advantageous, both cosmetically and because of elimination of the subsequent risk of umbilical hernia.

vNOTES does have some drawbacks, however. A bit of a learning curve exists in the setup of instruments, as well as in working at an upside-down angle. The procedure is also not universally applicable, such as with an obliterated posterior cul-de-sac because of stage 4 endometriosis, and with suture-intensive procedures, such as extensive myomectomy, which are not well suited for this method.

Where does vNOTES fall in the armamentarium of the gynecologic surgeon? It seems like an ideal procedure for surgeons who are used to performing vaginal hysterectomies and laparoscopically assisted vaginal hysterectomies. Surgeons with experience with single port surgery will probably also have an easier time transitioning to this procedure. We require more high-quality evidence (randomized controlled trials) to compare vNOTES to other modes of access, such as total vaginal hysterectomies and total laparoscopic hysterectomies. 

Once we have this evidence and more clinical experience, we will see where vNOTES falls and whether it is just a temporary “fad” like NOTES or gains wide acceptance among gynecologic surgeons for certain procedures, such as hysterectomy and adnexectomy. 

Time will tell, but the early results are certainly encouraging.


Siddaiah-Subramanya M, Tiang KW, Nyandowe M. A new era of minimally invasive surgery: progress and development of major technical innovations in general surgery over the last decade. 

. 2017;3(4):e163-e166. doi:10.1055/s-0037-1608651

Misal M, Magtibay PM, Yi J. Robotic LESS and reduced-port hysterectomy using the da Vinci SP surgical system: a single-institution case series. 

 2021;28(5):1095-1100. doi:10.1016/j.jmig.2020.08.009

Einarsson JI, Cohen SL, Puntambekar S. Orifice-assisted small-incision surgery: case series in benign and oncologic gynecology

. 2012;19(3):365-368. doi:10.1016/j.jmig.2011.12.017

Housmans S, Noori N, Kapurubandara S, et al. Systematic review and meta-analysis on hysterectomy by vaginal natural orifice transluminal endoscopic surgery (vNOTES) compared to laparoscopic hysterectomy for benign indications. 

Articles

The reality is that traditional laparoscopic surgery provides excellent outcomes, great surgical exposure, and the flexibility to tackle almost any clinical situation. As such it is a high bar to overcome—vNOTES is essentially single port vaginal surgery.

vNOTES: where does it fit in the gynecologic surgery armamentarium?

vNOTES is a minimally invasive alternative for performing procedures—such as hysterectomies, cystectomies, and oophorectomies—in which the vagina is used as the surgical access route, providing access to the uterus, fallopian tubes, and ovaries. 

 is affiliated with Spartanburg Medical Center in Spartanburg, South Carolina, and is on the medical executive committee of the Ambulatory Surgery Center of Spartanburg. 

 managing partner of a large obstetrician-gynecologist (ob-gyn) private practice in Johnson City, Tennessee, was an early adopter of single-incision laparoscopic surgery and has provided contemporary mixed techniques to his patients for over 20 years. 

 is board certified in obstetrics, gynecology, female pelvic medicine, and reconstructive surgery, and practices in Southaven, Mississippi.

The panel discussion was moderated by Jon I. Einarsson, MD, PhD, MPH, deputy medical editor of 

; director of the Division of Minimally Invasive Gynecologic Surgery at Brigham and Women’s Hospital; and professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, both in Boston, Massachusetts. 

This transcript has been edited for clarity and meaning.

 I think a lot of ob-gyns are interested in knowing more about vNOTES. Which patients are good candidates for this approach?

When I first started, I looked for candidates who were very similar to a vaginal hysterectomy patient because I felt like I had relatively abandoned the technique of vaginal hysterectomy in favor of my laparoscopic instruments, and like Dr Pitman, I do a lot of single-site cases. I felt like I was already offering a very minimally invasive technique. But that said, I found that doing vaginal surgery is even more minimally invasive than my single-incision cases were. When I looked for candidates, I looked for ones who had prolapse, who had small uteri, who were multiparous, who had had no prior cesarean deliveries, things of that nature. But what I found as time went on is that a lot of that was unnecessary. And the real rate-limiting step for me is [that I] cannot perform a safe colpotomy and obtain access. And beyond that point, it becomes quite a bit easier to perform the procedure, and it is not at all like a vaginal hysterectomy once you place the laparoscopic port and begin to operate laparoscopically.

I agree. The idea of waiting until you have the ideal patient, when you adopt this procedure, is a mistake. You just need to evaluate each patient individually. If they’ve got an accessible vaginal apex, where you can do that colpotomy, proceed. This technique is adaptable and very exciting.

I would say that from my standpoint, everybody wants to pick the easiest and best cases first. But if you don’t start doing them, the volume of doing them is more important than the type of case you’re doing. So very quickly, I was at the point where I was like, “I’m going to consider everybody for vNOTES, and then I’m going to exclude people based on certain criteria.” But I think that vaginal surgery begets vaginal surgery. The more vaginal surgery you do, the more comfortable you get with it.

Dr Hardin, maybe you can answer this first. What are your contraindications? You wouldn’t do this on every case, would you?

I basically switched from complete laparoscopic assisted vaginal hysterectomy to vNOTES. Several of my partners are robotic surgeons, but since I adopted this, I have sent

1 patient to them for robotic surgery. And it had to do with a possible borderline cancer that I did not want to rupture through the vagina that was a large mass. Otherwise, I have attempted every other hysterectomy since March, when I began this, through vNOTES.

We need to counsel our patients that we want to proceed in the least invasive way possible. You don’t lock yourself into “This is where we’re going to do it.” I explained to them, “I’m going to evaluate you under anesthesia, and plan A is the vNOTES. I think that’s the best way to proceed.” I did my training in April. And I’ve done 90% of my hysterectomies now [with] vNOTES since then.

I agree with that in general. But when I counsel patients, if I know that I need the manual dexterity and 3D visualization of the robot for deep endometriosis in the anterior compartment or in the pelvic neuroanatomy, and if I’m going to be working in those spaces doing neuro resections, I probably wouldn’t start with the vNOTES approach. I would either do those robotically or refer them to someone who has a high volume of that type of procedure. But those are infrequent for my practice. My real thing is, I guess if I can make the colpotomy again, I’d like to keep it as simple as I can. I’ve also noticed that sometimes prolapse can make it difficult because it’s already out of the body, and so you have to kind of work around that. But surgeons who do that a lot have found that it simplifies prolapse. But for me, it’s: Is the anterior and/or posterior cul-de-sac completely fused or obliterated? If I can get in on either one, I can proceed with better visualization.

 What about other surgeries? Are you doing myomectomies, ovarian cystectomies, or other procedures through this approach?

I’ve done adnexal surgeries, [fallopian] tubes, and ovaries. I have not done the myomectomies yet. Again, just an early adopter. I’ve done 30 vaginal hysterectomies, and of course, also uterosacral [ligament] suspensions. That’s big for me because you can see the ureter so well and you know that your stitch placement is well away from the ureter and you can pull on the suture to make sure that the ureter doesn’t kink. To have that kind of reassurance is moving me away from the sacrospinous [ligament] suspension. So, I’m really pleased with the uterosacral suspension.

 Do you have any tips on how to get the colpotomy initial entry done?

The first thing is patient position. These patients don’t have to be as far down off the exam table or the operating table as in a traditional TVH [total vaginal hysterectomy] just because of the retractors you’re using. I think that helps them postoperatively as well. But make sure that they’re centered on the table, that their bottom is kind of at the very end of the table. I always start with a little bit of Trendelenburg [position]. I’m injecting more circumferentially around the cervix than I used to for my standard LAVHs [laparoscopically assisted vaginal hysterectomies]. I also went from a straight direct entry technique colpotomy to circumscribing and really taking kind of a wet, slightly moist, open Raytec gauze and advancing all the way around, and that helps you find posteriorly with an allis clamp where you really can kind of tug on it and see that it tents off the cervix. That makes it a little easier to make the posterior colpotomy. Making a big colpotomy is a really important step because the narrower your colpotomy is, the harder it is to get your ring placement in there, and then you’ll have the ring pop out.

In the past few years, since we came back and started teaching this, I found that there’s a kind of a bifurcation of what that rate-limiting step is. The most challenging step that you mentioned for many surgeons I think is the anterior colpotomy. I think our residency training programs are struggling to get vaginal hysterectomy numbers up, and the residents who are trained in the more recent years have had difficulty with getting adequate volume to feel very confident with colpotomy. Likewise, throughout the nation, there are numbers of surgeons who have relatively abandoned the vaginal route as their primary route. Despite the evidence that ACOG [American College of Obstetricians and Gynecologists] continues to champion that, vaginal surgery should be our first route and laparoscopy would be an acceptable alternative if it’s not feasible. I think the first step is if you’re comfortable with anterior colpotomy, the next most challenging thing is placing the access devices. These rings that we typically use, these V-path type rings that go in and roll down to allow us to develop a pneumoperitoneum, can be difficult to place if you haven’t been trained. To overcome that, I would say attend a training course like those that are sponsored by the iNOTESs through Jan Baekelandt, MD, and Applied Medical. They teach these techniques of how to place a ring, as well as introducer courses that have made it a lot easier for surgeons to overcome this challenging step.

 How do you bill for this? What’s the right billing rate code for this type of surgery?

We’re currently billing under the LAVH codes. And of course, there’s the less than and greater than 250 g. Same thing for the 58661 for salpingectomy. It’s still a laparoscopic case. If I move my ports to the left upper quadrant, that doesn’t alter whether I’m doing a laparoscopic hysterectomy or not. And likewise, it’s been our position that a LAVH is the same as VALH, a vaginally assisted laparoscopic hysterectomy. The only other option within the coding manual that I can find would be using a specials code.

 What prompted you to start offering vNOTES to your patients?

I was approached by one of the reps from Applied Medical who said, “Would you be interested in learning this new technique?” Then I went to a class this January and was really impressed with it. I thought my LAVH patients would do really well. But what if I could do it without any incisions and without all the rigamarole in the operating room [OR] where you start vaginally, go abdominally, come back vaginally, go back abdominally. It feels more efficient in the OR to start vaginally, stay vaginally. The number of instruments you need is probably one-third or less of the number of instruments that they would pull for an LAVH. From my standpoint, I want a new pack developed just for my vNOTES. I liked that it was just exactly what we needed—minimizing the waste. We use less suture, and after you do a few of them, you see how well the patients do and that makes you an adopter quickly.

Most definitely. They [Applied Medical] reached out to me because I had such a high volume of the single-site TLHs [total laparoscopic hysterectomies]. We get our training, and you think, “I’m doing the least invasive thing that I can do, either vaginal, or LAVH, or TLH.” This is the first time I’ve been excited since I finished my residency about something. Because the patients just do so well. They come in and they’re so happy, so thankful for the ability to get back to work in a week and resume normal activity so quickly. The transition from the single-site laparoscopy to this vNOTES has been pretty smooth. I’m excited.

I’ve always been interested in offering my patients the least invasive route. And interestingly, I’ve had a passion for teaching doctors in private practice. I like the interactions with other colleagues who have excellent ideas and can share those back with me. Somebody, I think it was Lee Cohen at Applied Medical, had said, “Do you know Dr Baekelandt? I think he’s friends with you as fellow MIGS director. But he’s over in Belgium.” So I come to hear about him through my teaching experiences. And shortly after that, I had the opportunity to speak to the Southern OB/GYN Society about [approaching] hysterectomy and morbidly obese [patients].” I took the unpopular but realistic perspective that you should do it in the manner that you’re best trained to handle. So for some, it’s laparoscopic; for some, it’s open; and for some, it’s vaginal. People who supported the data reminded me that vaginal is the answer if you look at studies. I got convinced of the need to reengage vaginal surgery and started visiting with Dr Baekelandt in Belgium and learned the technique, and the aha moment for me was when he placed the ring in and showed me that you don’t have to do an anterior colpotomy. You can develop a pneumoperitoneum and do that laparoscopically even. I realized then that I could overcome the colpotomy fear that I had. Those first few patients came back, and the testimonials they gave kept me going after I tried this new technique. But it was the 33rd patient whom I’ll never forget, who changed my life. She was 685 lb, and 5 ft 2 in. And she had a large abdominal mesh, a prior colostomy, and an operative report on her chart that said, “Do not go back in this pelvis, essentially, or you will be in her bowels again.” And I remembered I had said, “The evidence says you should try this vaginally.” I didn’t believe I could do her case vaginally from her other challenges. But we were able to do that with the vNOTES approach vaginally. This patient convinced me that we need to really explore this.

 What do the data look like in terms of comparing vNOTES with vaginal hysterectomy, like pure vaginal hysterectomy, and/or robotic or laparoscopic hysterectomy?

 While currently there’s good evidence for hysterectomy, there’s level 1b and adnexectomy with the classic HALON trial and the NOTABLE trial, which was looking at adnexectomy.1,2 Evidence exists to tell us that [vNotes] is at least as efficacious as, if not better than in some ways, standard laparoscopic hysterectomy. To my knowledge, there’s not a direct head-to-head vs vaginal hysterectomy. And I think those are data that those of us who are engaged in this field want to see developed. That is a need for those of us who are performing it to continue to do that. But the data are coming out more and more, especially in some other countries where they’ve engaged it quicker, in Europe and in China, places like that.

I agree. I’m excited to see a head-to-head. Anecdotally, when you think about the techniques with vaginal hysterectomy, traction is downward constantly. With vNOTES, the movement is out of the pelvis—you’re actually pushing the specimen up and medially constantly during the procedure, so you’re not really pulling down on those ligaments. I hypothesize that the pain is going to be much less than a typical vaginal hysterectomy for a large uterus.

I think there is a lot to be said about how much tissue manipulation there is involved in traditional vaginal surgery, just clamp-cut-tie surgery vs this. The traction you put on it is minimal. And then you’re not strangulating vascular pedicles like you do when you tie things off with a suture. I think it’s probably going to be less scarring to people because it’s probably less inflammatory just like traditional laparoscopy taking out ectopics vs leaving vicryl or chromic in there and how inflammatory that can be. But as a woman who has had 2 babies, and I’ve had a cesarean delivery and I’ve had a vaginal delivery, the ligaments are an issue for sure.

Also, I will say there are some meta-analyses that have been published. There was one in December 2020 in the 

.³ But that was a systematic review and meta-analysis comparing hysterectomy by vNOTES vs laparoscopic hysterectomy for benign indications. It showed that there was equal efficacy for operation, operating time, hospitalization, and estimated blood loss with no differences in complication rates, readmission rates, or pain scores at 24 hours. Those types of data exist to say that at least it’s as good as TLH. And I don’t think that we’re at the point where we have the head-to-head comparison to vaginal, but what I would say is we’re not doing just vaginal nowadays.

 I think Dr. Hardin alluded to this, but you can see everything. And not just you but everybody in the OR can see what you’re doing. Which I think is one of the reasons vaginal surgery or vaginal hysterectomy hasn’t taken off as much. Because when we’re doing laparoscopic cases, everybody [in the] OR can see, you can teach hundreds of people what you’re doing there.

That’s correct. And I can do it with 1 less assistant as well. So that’s another level of efficiency when [there is] 1 less person in the OR.

The camera doesn’t have to be trained as much either because with laparoscopic surgery you’re the person who’s running that camera. It can be a really great limiting factor. When you’re working in such a small space with a 10-degree, 30-degree scope, it’s pretty much minimal manipulation of the camera for the whole case.

And cost is one of those things that I think we’re starting to look at nationwide about what’s the ethical nature of how much we spend on a patient. When I started treating these patients, OR staff members told me, “We don’t need that many instruments.” And so, they quickly made a new tray and their turnover time reduced. Anybody could set this case up. It didn’t require a special knowledge of equipment. It really didn’t require a lot of time for sterilization. Where I could previously perform 3 major cases in a day, 3 to 4, I can easily do 5 to 6 now. And the actual cost of instrumentation was lower because 90% of it, or more, is reusable, and that’s huge.

 Is there any advice for the reader to make the transition to vNOTES easier?

One thing I would say is that most people who are learning these procedures, at the courses that I’ve gone to help teach, are people who have not just gotten out of residency in the last year or 2. So remembering why you’re doing it: It’s always uncomfortable to learn something new. You’re going to have frustrations—anytime you use a new instrument in the OR, anytime you have a new scrub tech in the OR, there are frustrations. You may say, “That was too frustrating. I had to put the ring in 4 different times.” But every time it gets a little bit better, a little bit better. And I think that’s my thing, kind of where your mind-set is when you start.

I would say to understand the surgical geometry. When Harry Reich[,MD,] first showed us that we could use a laparoscope and some instruments that we were doing tubals with to take out a uterus, it was a watershed moment in our careers that generated many other techniques and tricks. We’ve always been vaginal surgeons. It’s what makes us different from general surgeons. Attend a course where you can network with other surgeons; develop relationships and proctorships until you feel confident. Lean on those people who’ve walked down that path before to work with you and hold your hand getting started. Understand that you’re going from the least invasive route to a more invasive route. There’s no harm in starting vaginally converting to laparoscopy any more than there was starting a laparoscopic case and converting it to an LAVH. It’s just reversing the order of events. I believe that those tips would help anyone who’s starting out become more successful.

Baekelandt J, De Mulder PA, Le Roy I, et al. HALON-hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol). 

. 2016;6(8):e011546. doi:10.1136/bmjopen-2016-011546

Baekelandt JF, De Mulder PA, Le Roy I, et al. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) adnexectomy for benign pathology compared with laparoscopic excision (NOTABLE): a protocol for a randomised controlled trial. 

. 2018;8(1):e018059. doi:10.1136/bmjopen-2017-018059

. 2020;9(12):3959. doi:10.3390/jcm9123959

Contemporary OB/GYN® held a panel discussion in September with 4 renowned minimally invasive gynecologic surgeons (MIGS) who discussed vaginal natural orifice transluminal endoscopic surgery (vNOTES).

MIGS surgeons discuss novel vNOTES technology

Meet Contemporary OB/GYN®'s Deputy Editor, Jon I. Einarsson, MD, MPH, PhD in this segment of 

 to Einarsson's panel discussion with Gaby Moawad, MD, and Robert K. Zurawin, MD, as they discuss the new and existing surgical technologies and techniques available in ob/gyn.

Videos

Introducing Contemporary OB/GYN®'s Deputy Editor, Jon I. Einarsson, MD, MPH, PhD.

Meet the Board: Jon I. Einarsson, MD, MPH, PHD

Jon I. Einarsson, MD, PhD, MPH, Gaby Moawad, MD, and Robert K. Zurawin, MD. 

Dr. Moawad is on the Speakers Bureau, Intuitive Surgical. Dr. Zurawin is principal medical advisor for Memic Innovative Surgery Ltd., the company that created the Hominis surgical system.

Three esteemed surgeons discuss technology, weighing the pros and cons of existing and newly developed platforms. 


Surgeons Panel Discussion

 Deputy Editor Jon I. Einarsson, MD, MPH, PhD, moderated a discussion with Robert K. Zurawin, MD, adjunct associate professor at the Baylor College of Medicine, Department of OB/GYN; and Gaby Moawad, MD, clinical associate professor of ob/gyn at the George Washington University School of Medicine and Health Sciences, and founder of the Center for Endometriosis and Advanced Pelvic Surgery. 

In this article, adapted from the video interview, the surgeons discuss the current state of robotic surgery; the current robotic options available; and how new technology can be factored into clinical practice, the focus of which is the Hominis surgical system. 

The Hominis is a transvaginal robotic-assisted system that has combined the visual advantages of laparoscopy with the transvaginal approach. It is said to enhance and enable transvaginal approaches. Its humanoid design includes two flexible, snake-like arms that mimic the movement and mobility of human arms.

Dr. Zurawin is principal medical advisor for Memic Innovative Surgery Ltd., the company that created the Hominis surgical system. 

Dr. Moawad is on the Speakers Bureau, Intuitive Surgical.

Much of what the surgeons discuss is moving the needle on how hysterectomies are performed, since the vaginal approach remains the preferred method in the specialty, but is performed at a lower rate due to myriad factors. Abdominal hysterectomy is the most widely used approach. The Hominis is not yet for sale in the U.S. and pending FDA approval. Experts will present on it at the American Association of Gynecologic Laparoscopists Virtual Conference, being held Nov. 6-14.

“Technologies are coming through that will facilitate the ability of those with general knowledge of surgery to approach surgery safer and more cost-effectively, and make it more accessible to them to do these kinds of procedures,” Dr. Zurawin says.

The surgeons see the landscape for surgical technology constantly evolving, but that doesn’t replace the need for highly skilled surgeons. Patient outcomes remain the most critical goal. Artificial intelligence and machine learning could help modern medicine create algorithms to better understand triaging patients to different modalities of surgery, whether vaginal or laparoscopic.

“At the end of the day, it is the surgeon’s skill that is the most important factor and we often forget that,” Dr. Einarsson says. “That is the most important ingredient. New devices that are coming out are facilitating the existing surgeon’s skills and help surgeons to develop those skills.

“We do not need to glorify another robot,” he says. “We need to improve the innovative aspect of how the robot or how the computer-assisted surgery can help the surgeon standardizing the outcome of the surgery, rather than relying on a human to make decisions.”

The discussion begins with Dr. Zurawin, who provides background.

: You wanted to address the vaginal approach and this really speaks to the greatest unmet need of gyn surgeries because every single gynecological organization recommends vaginal hysterectomy as the preferred method of hysterectomy. But the needle hasn’t moved past 15 or 16%, forever. 

The reason for that is anatomy, surgical training, and discomfort with surgeons who are coming through training - and even existing surgeons - who perform vaginal surgeries. The key to vaginal hysterectomy rests in safe dissection into the anterior/posterior cul-de-sacs, a feeling of security with securing the vessels, as well as avoiding the bladder and the rectum. 

That is not only unchanged, but it has actually gotten worse, because the world of vaginal surgery now is out of the hand of the generalists and has moved to urogynecologists and some of the oncologists, and of course, specifically trained minimally invasive surgeons (MIGS-fellowship trained surgeons). So how can you possibly have vaginal hysterectomy as the preferred method of hysterectomy? Practically nobody knows how to do it. And one of the challenges is anatomy, but if you remember, back when many of us were in training, cesarean section was only a small percentage of deliveries and now it’s anywhere from 30 to 50 to 70 percent, depending on where you are. 

Once you perform a c-section, you have an increased risk of scarring in the anterior cul-de-sac, so in addition to just getting cleanly into the anterior cul-de-sac, now you have got to dig through that scar tissue. A number of publications have shown the feasibility of vaginal hysterectomy after a cesarean but it still is keeping most people away. The vaginal robot creates an opportunity to combine robotic surgery with a laparoscopic view and a vaginal single-incision approach. One of the advantages of that is that the entry is guided by a small umbilical laparoscopic scope. 

Then it monitors the entry of the trocar through the posterior cul-de-sac. You are not going to hit anything. It is direct visualization and then once the trocar is in, the robot arms are inserted and then retroflex. You can perform the hysterectomy and also adnexal surgery, and then remove the specimen through the colpotomy you made for the insertion of the trocar. The transvaginal robotic approach facilitates all those steps. 

Other robotic platforms have attempted vaginal surgery but they run into problems of entry. There are a lot of excellent surgeons doing vNotes (transvaginal natural orifice transluminal endoscopic surgery), which of course is a very nice modality, but again, you have to get into the anterior and posterior cul-de-sac, before you even get to put in the GelPoint. By that point, 90% of the work is done. After that, you might just as well put a couple of clamps on the uterine vessels and you’re done. I just wanted to give a little background on the vaginal approach. Of course Hominis still is awaiting FDA approval but it is at the final stages.

Dr. Moawad has done a lot of tremendous work not only on the cost but training; Dr. Zurawin turns the discussion over to him.

: These are all really great points that you brought in. We can start seeing why the value of robotic surgery would be beneficial in moving the needle towards vNotes or robotic vNotes. 

In addition to what you said, the important thing is that the robotic platform is enabling the surgeon to be in control of the visualization as well as all the operative arms, minimizing the use of multiple assistants. 

That always was a struggle when we did vaginal hysterectomies, where we have the learners, the surgeon and the assistant, all not being able to visualize clearly the important structures, like the ureters in vaginal hysterectomy, or other anatomical landmarks. 

That was, I believe, one of the drawbacks of vaginal surgery, especially when we get into more complex and difficult cases. The type of pelvis, the body mass index of the patient, and then the more complexity of benign gynecological surgeries (including endometriosis) all lead to increasing the challenges in the vaginal approach. 

The problem with endometriosis is that there are numerous surgeons who are not able to diagnose an obliterated cul-de-sac or having the tools to diagnose that before the surgery. 

Therefore, many rectovaginal endometriosis [cases] with the general ob/gyn are diagnosed by accident intraoperatively. Imagine now with trying to push vNotes or vaginal surgery to a wide variety of less experienced surgeons, thinking that this is the primary approach without appropriate training and triaging of patients, this will lead to multiple safety issues that can compromise the outcomes. 

Here I am going to play the devil’s advocate a little bit and open the discussion a little more, which is knowing that now most of the surgeries are done laparoscopically or robotically, or minimally invasive, let’s say, what could vNotes add to this safe laparoscopic surgery, especially now that we’re moving to less ports, more micro-ports, to minimize the injury or the trauma to the abdominal wall cavity?

: From my perspective, and this is obviously my biased perspective, I like to see what I am doing. I remember in residency when I graduated, I did my residency with Dr. Zurawin, actually, and we did a lot of vaginal hysterectomies at that time. I think I graduated probably with 50 or 60 of them and I felt very comfortable. 

When I got out I felt very strongly that I should be able to do all of these things and offer all of these modalities to my patients but then gradually just realized that there wasn’t any point because, if you think about the patient outcomes, whether you do it laparoscopically or vaginally, the patient outcomes are very similar but you can tackle anything laparoscopically, as opposed to vaginally, you kind of have to select patients a little bit more so I gradually moved to 100 percent laparoscopic. 

Especially if you’re dealing with more challenging pathology, I think you need to be able to see. I think that adds so much to what you are dealing with. You can deal with endometriosis, complicated cysts, adhesions, much better than vaginally. vNotes has been interesting technology because it does combine the vaginal surgery and being able to see. I think that is probably the key to allow more people to use that access port.

: Those points come together this way; first of all, full disclosure, Dr. Einarsson doesn’t do robotic surgery because he can do anything laparoscopically. He doesn’t need anything else because he has a brilliant understanding of anatomy and decades of experience with thousands upon thousands of cases. 

But for the purposes of this article, we are talking about the majority of gynecologists who don’t have those skills. Residents who finish now only have to do 15 vaginal hysterectomies to graduate, and they have a hard time scraping together even that number. They graduate without the skill or the confidence to perform vaginal surgery once they enter practice. 

The difficulty there really comes back to knowledge of anatomy. In terms of visualization, Dr. Moawad brings up a great point about obliterated cul-de-sac. Many people recommend a diagnostic laparotomy before a lot of this is done to know what you’re getting into before you get into it. Now here is the controversy: if you’re doing a vaginal surgery, why are you popping a laparoscope in there? But let’s talk about that. In 1991, Stovall and Ling1 published their very excellent paper on 91 patients who were scheduled for vaginal hysterectomy. 

Only a few of them were thought to be candidates, but when they popped in the umbilical scope, fully 90% of them were able to be done vaginally because the surgeons had the confidence of knowing the anatomy. That is really the elephant in the room here. 

Unless people are properly trained, it doesn’t matter what modality you use, you are not going to be unable to do it. Unlike the other unfortunate circumstances we had with vaginal mesh, and all these other procedures where doctors were trained in weekend warrior sessions where they would claim to teach you how to do it, this is not something that you can just grab onto. 

Another thing is the definition of a high-volume surgeon that is in the literature. A high-volume surgeon is what, 10, 12, major cases a year? You know, one a month? I mean I wouldn’t get on an airplane with a pilot that only flew once a month. I think what we are talking about is funneling these modalities into competent hands and yet facilitating the rest of the gynecologists who want to improve their vaginal surgery skills. I think vNotes is great; I think robotics is great; and I think laparoscopic surgery is great, but it needs to go into the right hands and that is the key. 

Now the next thing about that is the expenses, the cost versus the benefit, and again, I am not nearly as conversant in that as Dr. Moawad is, so maybe he can help us out with that.

: I’m going to talk about a very important aspect of robotic surgery, how it could help spread the robotic vNotes. And then when we look and learn from the experience about what robotic surgery did to open surgery, or laparotomy. 

When we talk about hysterectomy, robotic surgery was able to shift most of the laparotomy into minimally invasive where a laparoscopy was steady and this was shown clearly in a lot of the graphs that we have in one of our studies, which was published in 

 about the movement to outpatient hysterectomy in benign indications (in the United States, 2008-2014).

We can see that laparoscopic surgery rates were mostly stable from 2008 to almost 2016 in terms of percentage. Robotic surgery, where we thought before it could take away from the laparoscopic surgery pool, ended up shifting the more complex procedures done [via] laparotomy to a minimally invasive option. If we extrapolate those graphs, that might be the actual benefit [of] what robotic surgery could do to the vNotes, where it could shift a lot of the laparoscopic, transabdominal, or robotic transabdominal, into a vNote modality but eventually, it is going to take a lot of learning. 

Now in terms of cost, again, as most of the costs in the U.S., where we are talking the direct costs, comes from two things: The direct cost comes from the operative time length; and redundancy of using multiple instruments that have the same function. The third factor, which we never talk about, is the cost of complications, re-admissions, conversions, re-operations. This is what drives the major costs in the U.S. for surgery. 

It might not be true for other countries but this is the main cost factor here. The more efficient surgeon using the appropriate tools with the right training is what will help drive the costs down. 

We need to consider as well the opportunity costs, which is whatever the hospital can do with those resources that were not used if the patient was not admitted to the hospital; rather, what if the patient was discharged the same day with a minimally invasive surgery option? This is the total cost that we need to look at mainly.

Next, Dr. Zurawin elaborates on Dr. Moawad’s points about complications.

: This brings us to my concern about anatomy and patient volume. The issue that needs to be addressed, with any new technology, from endometrial ablation to hysteroscopic sterilization, mesh - anything that we were doing -it’s not the device itself, it’s the surgeon. In terms of post-operative complications with robotics, I think all three of us see medical-legal cases that are related to robotic surgery and most of them that I see are thermal injury. 

They mostly involve burning the bladder, a burning of the bowel, or of the ureter. I think that visualization is important, of course, but unless we properly train our surgeons, unless we change our training programs, we’re really going to see an acceleration of this problem. 

That is why, when we adopt these technologies, we need to put them in the hands of the people who can do it. In terms of Dr. Moawad’s point about robotic vNotes, I think that is an excellent future for the specialty. It takes all the advantages of the vaginal approach, all of the technical and engineering aspects of robotics, as well as cost and recovery. 

Again, I just feel strongly, at least in the beginning, these technologies have to be directed or restricted to people who really, really know what they are doing. 

One of my other fellows introduced vNotes and robotic vNotes into China where it has really caught on very big but it is a different market there and it’s a different group of surgeons. Gynecologists in China do thousands of cases, many thousands of cases. We don’t have that here in the USA.

: If you think about what is most important, obviously that is patient outcomes, and what is the most important thing there, I agree with you, that it probably is the surgeon’s volume. It’s not which robot they’re using or whether they are doing laparoscopic or vaginal surgery. Of course, that should be the main focus. 

My view on that is actually a little bit more optimistic because I think that more and more cases, especially in urban areas, are going to high-volume providers. We’ve been graduating now a few hundred fellows in laparoscopic surgery or minimally invasive gynecologic surgery, and they’re gradually building their practices and taking more cases. 

If you’re an ob/gyn specialist and coming out of school, then your surgical volume is so low and it’s very hard for you to get up to speed on that. It is almost untenable in larger urban areas because high-volume surgeons are doing much more cases, and I think that translates to better outcomes for patients, which obviously is what we want. I think that is happening, at least in urban areas. In smaller communities, it is not as clear cut.

The debate still is ongoing in the specialty that robotics surgery is less expensive, and there are those who will say it is more expensive. What is the surgeons’ take? As Dr. Zurawin asks, “What is the real news about costs of robotic surgery, if you consider all factors, with costs and morbidity, costs to the hospital and to the insurance system?”

: This is always going to be a question of which comes first – the chicken or the egg? Because it’s the same debate and let me tell you why. All the published studies in the literature have a major bias, which is that we don’t compare apples to apples and oranges to oranges. 

The whole issue arises because we don’t have a complexity score for hysterectomy. What we use as a proxy for complexity is the weight of the uterus, which we all know is nonsense. 

The challenge with robotic surgery is that we do not have a way to separate the learning curve of different surgeons. 

But it is not only the learning curve, because many people are lured that they will become expert surgeons if they do 20 robotic cases and this is probably some of the marketing pitfalls to engage people. But the proficiency curve, which is around 100 cases, and 100 cases to be met for surgeons who are even considered high volume doing 15, or 20, or 30 a year, that is going to take them 3 or 4 years to get to that level. 

The major issues we have are defining the complexity of a hysterectomy and assessing the surgeon’s skills and then we can compare groups using the same metrics. 

When it comes to costs, you have papers like Dr. Luciano’s: “The impact of robotics on the mode of benign hysterectomy and clinical outcomes,”

 where he studied the premier database and found the complication rate with robotic surgery, despite obesity, is lower than laparoscopic and open surgery. 

 the sacrocolpopexy randomized trial, again, such studies show that robots are more expensive and require longer time and that is why it will be more costly. But in most of the studies there was no difference between the complications between laparoscopy and robotics. Having a laparoscopic surgeon spending four hours in the OR where the costs of an OR minute in the U.S. is $85, is very different than having a robotic surgeon doing the same surgery in one hour. It is going to be way less expensive. 

Therefore it is surgeon-dependent if you have a laparoscopic surgeon admitting the patient overnight just because this is the practice, where a post-anesthesia-care-unit minute costs $15 versus a robotic surgeon sending a patient home after three hours. 

That is going to be a major difference in cost. So there are practice-dependent cost incurrences; surgeon-skill-dependent cost incurrences, and as you said before, the right tool is the right hand to lead to the best outcomes not only financial-wise but also medical wise.

As BMI increases in the U.S. population, the surgeons also considered how modalities should be considered when working with morbidly obese patients.

: A transvaginal approach has definite advantages in morbidly obese patients. You don’t need the steep Trendelenburg necessarily that you do for robotics. 

I’d be interested to know your experience, Dr. Moawad, and also Dr. Einarsson, you deal with a lot of morbidly obese patients and also in your training program. How do you see the people that you’re training dealing with the epidemic of obesity and its relation to modality – laparoscopic, robotic, and vaginal?

: I want to first echo what Dr. Moawad was saying. I now have done a few randomized trials on robotic versus laparoscopic surgery and we’ve done some retrospective and cohort studies and all. Most of our studies are biased, I will admit that, because I am a much more proficient laparoscopic surgeon than a robotic surgeon. 

I think that is probably true for most surgeons that they have their modality that they’re really, really good at and then the other stuff they’re not quite as good at. It’s hard to do randomized trials from surgical access because the bias always is on the surgeon. 

Population-based studies or having groups that are really good at or in similar environments, and comparing those outcomes, are probably the least subject to bias but it’s never going to be really perfect.

In terms of obesity, I will offer a couple of things. The bigger the patient the more important patient positioning is but what I found helpful with laparoscopy over robotics in obese patients is that I can have complete freedom to move the patient the way I want at any time during surgery so I like to put the patient in a very steep Trendelenburg like 30 degrees, pull the bowel away, and then decrease the Trendelenburg, until the bowel starts to move down but it’s not in my way, and then stay in that position. 

Then you can always put the patient down flat if anesthesia is having a problem then go back. Sometimes you do have to maneuver that around. I know that obviously there are those tables that move with the robot where you can move everything and you have the same freedom but not everybody has access to that. So that is one advantage. 

But I know a lot of people like robotics for obese patients and have different reasons and maybe Dr. Moawad can elaborate on that.

: With obesity, the advantage is that you do not have the fulcrum effect from the thickness of the abdominal wall as you do in laparoscopy. Many times, of course, for more experienced surgeons they can overcome this or overlook that but many times this is a challenge. 

Plus, most of the laparoscopic instruments sometimes for extremely obese patients start becoming a challenge and we do use bariatric [instruments] because the [other instruments] don’t get to where you want to be. 

With obesity, the precise movement with a laparoscope will become an issue when we are dealing with way more complex cases. In laparoscopy, many times, when you have a more complex case, you rely more on your assistant, in the sense that they have to do more, and be more actively engaged in the surgery rather than when doing a simple case. 

You have to rely on the surgeons being ambidextrous for super complex cases, where, if the assistant cannot do the job on their side, the surgeon can move with the same efficiency with both hands. These are challenges mitigated by robotic surgery. 

I think one of the values nobody talks about in robotic surgery is how your assistant becomes less and less relied upon throughout the procedure where you can have three arms and a camera that you fully control rather than, at most, two arms with laparoscopic surgery. 

This is one of the values we go back to, the robotic vNotes, one of the values that robotic (has is that it) could help overcome the challenges of traditional vNotes laparoscopy. With obesity, you have even more limited range of motion with less precision.

Dr. Moawad asks Dr. Zurawin to provide his perspective on managing obese patients with the Hominis platform. Dr. Zurawin has been involved in the trials with the platform in Belgium.

: The largest hysterectomy we’ve done with Hominis is 15-week size, which is good enough, even with some adhesions. We have not done many morbidly obese patients because the trials were done in Europe and Israel where the population is generally thinner. 

We also have not had to put them into steep Trendelenburg. Of course, vaginally, it’s a whole different world because of the way you position the patient, the bowel is normally out of the way, unless there are some adhesions that stick the bowel to the cul-de-sac. 

We haven’t run into those problems but the question back at you is for the robotic vNotes, or any of your vNotes but especially robotic vNotes, don’t you also pop a scope into the umbilicus and look before you do your vNotes? Or are you just going to go in there, hoping that we don’t have a deep infiltrating endometriosis?

 I don’t do vNotes but I think access to the abdominal cavity is going to be the main issue, in addition to the reverse anatomy that the surgeon now needs to be familiar with. When they did vaginal surgery they went by tactile feel; they didn’t go by look and then even for the laparoscopic surgeons, seeing anatomy in reverse is going to be also something that they need to be accustomed to. 

They need to know the different views of the different landmarks. Because now as a laparoscopic surgeon when you look at the abdomen from open incision you start feeling the difference how much you’re more comfortable doing laparoscopy and finding the ureter than when you’re looking above into a laparotomy incision especially for challenging cases. 

Nobody talks about the type of pelvis in pelvic surgery, and I think that is going to be one of the major determinants in the success of vNotes. Because if you have a platypelloid pelvis where the pubis bone is very close to the coccyx, then the range of motion of the straight stick instrument doing vNote is going to impact the difficulty of the cases. be way more challenging to do more complex cases. 

If you have an android pelvis that is going to be a deeper pelvis that requires longer instruments to reach the surgical site, so there is a lot of learning. I think we go back to the same thing where we thought it should be done by expert surgeons before we can find a standardization of triage because triaging patients to vNote is going to be the main issue. 

Using a standardized patient triage guidelines as an initial metric will be helpful to increase the success of that surgery and minimize the complication would be key.

: Just to step up from that point, where do you see vNotes and Hominis robot enter clinical practice? Where are these going to be useful? VNotes is being used for sacrocolpopexies and ovarian cysts, etc. Where do you see this vaginal robotic access fit into clinical practice?

Studies on procedures other than vaginal hysterectomies have been conducted with the Hominis, including a bilateral salpingo oophorectomy.

 Other procedures have included treatment of ovarian cysts, adhesions, fibroids and prolapse.

: But cases like sacrocolpopexies – remember you’ve got a colpotomy – so just by that nature it makes it a little harder to do sacrocolpopexies with that Hominis robot because it goes in and it retroflexes 180 degrees. So that hasn’t really been tried yet. I think where its utility is going to be proven is cost.

It’s a small, portable, inexpensive robot for, at least at this point, cases that don’t need a bigger platform. In future iterations it will be used for other surgical devices, cases besides gynecology – head and neck surgery, and so on. 

But in keeping to the gyn area, I think that it is going to find its niche in people who have had challenges in doing vaginal surgery and helping them enter into the world of vaginal surgery because entry into the peritoneal cavity is easy; dissection is easy; and it allows them to use a vaginal approach but with much better visualization. I think that is going to be where it starts. 

Then when version 2.0 or 3.0 comes out there will be more indications. But I think it will encourage people to go back into that vaginal surgery as the preferred method of gynecologic surgery. 

Summitt RL Jr, Stovall TG, Lipscomb GH, Ling FW. Randomized comparison of laparoscopy-assisted vaginal hysterectomy with standard vaginal hysterectomy in an outpatient setting. 

Moawad G, Liu E, Song C, Fu AZ (2017) Movement to outpatient hysterectomy for benign indications in the United States, 2008–2014. PLoS ONE 12(11): e0188812. https://doi.org/10.1371/journal.pone.0188812

Luciano, A. A., Seshadri-Kreaden, U., Gabbert, J., & Luciano, D. E. (march 2016). The impact of robotics on the mode of benign hysterectomy and clinical outcomes. 

The International Journal of Medical Robotics and Computer Assisted Surgery

, 12(1), 114-124. doi:https://doi.org/10.1002/rcs.1648

Paraiso MF, Jelovsek JE, Frick A, Chen CC, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. 

 2011 Nov;118(5):1005-13. doi: 10.1097/AOG.0b013e318231537c. PMID: 21979458.

Lowenstein, L., Matanes, E., Weiner, Z., & Baekelandt, J. (July 2020). Robotic transvaginal natural orifice transluminal endoscopic surgery for bilateral salpingo oophorectomy. 

European Journal of Obstetrics & Gynecology and Reproductive Biology: X,

, 100113. doi:10.1016/j.eurox.2020.100113

Three esteemed surgeons discuss technology, weighing the pros and cons of existing and newly developed platforms.

The state of gynecologic robotic surgery

For the cover story in this technology-focused issue of 

most dangerous but sometimes overlooked step of laparoscopic surgery,

It is puzzling how little innovation has taken place for this step, considering that over half of all serious injuries and deaths happen during abdominal entry. The Veres needle was invented by Janos Veres in 1932 and was initially intended for treating pulmonary tuberculosis by causing pneumothorax and collapsing the lung.

Later, Raul Palmer adopted it for use during laparoscopic entry.

Einarsson is Deputy Editor of Contemporary OB/GYN, Director of the Division of Minimally Invasive Gynecologic Surgery at Brigham and Women’s Hospital in Boston and professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School.

The basic design of the Veres needle is simple and hasn’t changed in almost 90 years; it is an outer sharp hollow needle with an inner blunt spring-loaded tip. The spring-loaded tip is retracted during passage through the abdominal wall and then springs forward upon entry, thereby potentially reducing the risk of visceral injury by the outer sharp needle. 

However, this is still a blind technique and injuries do happen, perhaps more often than we realize. The 2mm diameter of the needle is beneficial since if the needle penetrates through a bowel wall, the small defect may self-seal, while a 5mm defect is too large for that to happen.

A useful rule of thumb is that if a device or method has been unchanged for more than 15-20 years, it is time for an upgrade. This certainly seems to be the case for the Veres needle.

Janos Veres was a Hungarian internist and his needle was not recognized outside of Hungary until he published on it in a German journal in 1938.4 It then became commonly used, but Dr. Veres never collected any royalty on his invention and later gave his patent to Aesculap for a few kilos of coffee!

 This altruistic approach also led William T. Bovie to sell his exclusive patent for an electrosurgical generator for one dollar.

This certainly indicates that physicians and inventors might benefit from a few lessons in business prowess, but it also begs the question, how valuable is an idea? The initial reaction might be that the idea for a new device is the most important component, but I have gradually come to the realization that it isn’t. 

During the development of several devices I have noticed a common thread. After filing the initial patent and doing some development, I often solicit helpful feedback from other clinicians. Invariably, one or more of those experienced surgeons will say “I had thought of that too!” 

Some might even accuse you of “stealing” the idea from them. This is why I always write down the idea as soon as I have it, sketch it out and put my name and date on it and then scan it in digitally so that it is clear when the idea was conceived. 

While this doesn’t help with patent filing, since the patent office goes by “first to file” and not “first to invent,” it can help to convince colleagues that the idea was indeed not taken from anyone else. 

The actual pursuit of the idea is what is important, and this pursuit is complex, time consuming and expensive.