My opinion, Natural Orifice Transvaginal Endoscopic Surgery is here to stay.

There is no question. To paraphrase Dr. Sues, patients don't like scar upon thar, even if the scars are minimal, and the results are better.

NOTES is a difficult procedure for most intraabdominal procedures until now. I believe that this procedure will be an alternative approach in laparoscopic multiple trocar or single incision laparoscopic procedures.

Please try to analize the risk benefit balance compared to "conventional" 2-3 port laparoscopy, especialy when 2-3mm tools will become more functional and dependable.

Even if as Doctor Aviel Shapira of Ben-Gurion University opinion patients don't like scar upon thar, even if the scars are minimal, in my opinion, Natural Orifice Transvaginal Endoscopic Surgery (NOTES ) is, at the moment, a too much complicated procedure, for most of surgeon, and intraabdominal procedures. NOTES procedures are not well standardized and instruments are not well developed, and the procedures are not very popular among surgeons. I believe that Notes will be an alternative approach at the traditional laparoscopic multiple or single incision procedures, in the next future, but after the technological and a surgical procedures standardization.

Dear Massimo,

Let me give you an analogy. Patients with achalasia can be treated either with Heller Myotomy (HM) or Balloon dilatation (BD). Objectively, HM is more effective and safer than BD. Moreover, by covering the myotomy with a fundic flap, it also prevents GERD (although not everyone does it) which is a common complication of BD, It only takes 4 incisions to do a laparoscoic HM. Yet most patients prefer BD.

I agree with you that at the present time NOTES is a difficult undertaking, but the demand will force us to learn, and like any operation, it becomes easier with time. It is not for me, as I am too old to learn new tricks. But young surgeons will have to adopt it, and soon it will be as easy for them as is laparoscopic cholecystectomy.

My above message also addresses Doron's concerns. The case of Achalasia proves that the risk benefit ratio does not really make a difference to the patients, as long as it is not too large. It is the perception of the patients of their body image, and they don't want scars, however small, even if the risk is somewhat higher, and the success rate is somewhat lower.

And they prefer 3 small scars to a single large one. Why else would they opt for laparoscopic unilateral inguinal hernia repair? The data is clear, open repair with mesh is safer, and has a lower recurrence rate than laparoscopic repair. And don't argue that it is the pain. Just provide adequate analgesia with oral narcotics for a few days (the only proven advantage of lap inguinal hernia repair is a lower requirement for pain killers, but these are much cheaper than the laparoscpic equipment - just give enough)

NOTES has been taken with scepticisim as a new method and every body remember the rejection of Muhe lap.chole by German society in 1980s.

However,we have to give balanced opinion,NOTES applications are many and currently we are practicing them(German regsistry included more than 500 NOTES cholecystectomy/In the UK we are behind Europe and no single case of NOTES cholecystectomy was done ),they are good when the case fulfills the indications criteria.NOTES on the other side suffers from limitations and the two important of these are:1.Instrument and technology to produce a working unit that is practical for safety,time and and cost.

2.minimal access expertise,which needs extensive training.

NOTES has create lots of debates among young enthusiastic and old near retirement surgeons.This has led to produce two schools of thoughts.

One for and the other against and this is natural.

The bottom line is there are current applications but NOTES can not achieve the success and acception of Lap.Chole in its current equipments ,scopes ,instruments and the required minimal access experience.

Dear Aviel, patients' preferences is the least of an evidence based argument. It doesn't mean or prove anything. Too many biases are involved: media exposure, industry benefits, doctor's ego and other financial interests. If patients had the fair chance to choose based on non-biased information they would choose the same as you and I would. You must admit that the delta advantage of NOTES compared to standard laparoscopy is not even close to the huge difference between open and laparoscopic approaches.

Dear Drs.

I think NOTES is feasible procedure at least in the procedure EFTR:endoscopic full thickness resection. Our univesity:Kagawa University has already developped Full thickness suturing devices and couter traction devices. I think EFTR will be developped gradually toward pure NOTES. In Japan, ESD is already ordinal treatment procedure for digestive cancer. So, Our group:Kagawa NOTES project is going to the next step. We: endoscopists,have now already learn Surgery for 4 years because it is need to study surgical anatomy to perform pure NOTES and open surgery if needed. Historically,from the surgical point of view, new procedure replace old one. At first, we modestly learn surgery and at the same time we developed new flexible endoscopic devices.

Doron,

You are assuming that people are rational in their decision making. In fact, there have been many studies that prove that most of us are not. The pioneer studies of Tversky showed this very clearly (the work won the Nobel prize in economics).

I agree with you that a rational person would reject NOTES at the present time. However , first, it is too early to tell for sure. Laparoscopic cholecystectomy was also rejected initiallly. Second, if the difference in post operative morbidity would not be large, NOTES will win, even if it would not be a rational decision.

Avi

Dear Avi, my recent answer remains the same and stands against your wishful arguments.

Dear Doron,

My ansewer is anything but wishful. It would be fantanstic if all human beings acted rationally. I just described what is actualy happening in our world, and what is actually happening is that most of us choose treatments not based on data and hard facts, but on gut feeling and external circumstances, This approach is usually harmful, but not always. Lap cholecystectomy was inititially rejectrd by most academic surgeon, but took hold in spite of that.

Breast conservation is another good example. At the time it was widely accepted, no studies showed a survival rate that even came close to the results of unmodified radical mastectomy as performed by experts (greater than 80% 10 year survival for palpable cancers, without any chemo). For most women, body image was more important.

Even today, the outcome of breast conservation for stage IIb is not as good as that achieved by Haagensen, Ferguson, and others with radical mastectomy alone. But who of us even remembers how to do a proper radica mastectomy - an operation that took 5-6 hours by the best hands? FD Moore writes in his autobiography that as a second year resident, he was doing only simple operations, like gastrectomy. Complex operations, like radical mastectomies were done only by the 5th year residents. Funny, isn't it?

This phenomenon is not limited to medicine. It occurs in all branches of science. Read Thoms Khun's book on scientific revolutions. You will find that even in the so called exact sciences, social pressures and gut feeling play a more important role than we like to believe.

Avi

My current understanding of NOTES is that it includes two different sub-entities: 1)Endoscopic surgery that deals with surgical actions that do not involve organs beyond the serosal / external layers of the GI tract (such as POEM, ESD, full thickness resection of GI lesions and closure of GI perforations etc.). 2) Trans GI walls endo-laparoscopic surgical acts that go beyond the GI tract to adjacent organs. The 2nd entity is the "real" NOTES that requires further technological advancement, further proof of relative safety. For the time being we are not there yet. We lack adequate technology and instrumentation. As for now the delta advantage of NOTES compared to standard laparoscopy is not even close to the huge difference between open and laparoscopic approaches. Not everything that can be done, should be done !!!

I share your understanding, and the final statement, ie, that not everything that can be done, should be done is absolutely right.

At the present time, these procedures are clearly investigational, and should only be performed in the framework of a formal study, with IRB approvement, and detailed informed consent.

However, the target is only to show non-inferiority in the rate of serious complications, such as CBD injuries. Failure rate and procedure time are less important, as one can always convert to lap or open cholecystectomy in case of failure, and both are a function of the learning curve. Of course one should also look at the costs (which include operating time). But the costs are up to the patient or the health care providers. They are not our direct concern. It is not a criterion which FDA or other regulators use to approve or disapprove a particular drug or device.

One might argue that the risk of CBD injury also depends on the learning curve. I think this argument is false. Nobody will do a transvaginal cholecystectomy without priror expertise in lap cholecystectomy. Thus any operator will be familar with the anatomical variations. If the rate of CBD injuries will turn out to be highert than in standard operations, the problem must be attributed to NOTES.