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CHAPTER 25 Training the Gastroenterologist for NOTES
https://t.me/med1917
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58 Gorecki PJ, Hinder RA, Libbey JS, et al. Redo laparoscopic
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59 Mercer CD, Hill LD. Reoperation after failed esophagomyotomy
for achalasia . Can J Surg 1986;29:177–80.
60 Inoue H, Minami H, Kobayashi Y, et al. Peroral endoscopic
myotomy (POEM) for esophageal achalasia . Endoscopy
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61 von Renteln D, Schmidt A, Vassiliou MC, et al. Endoscopic full -
thickness resection and defect closure in the colon . Gastrointest
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62 Elmunzer BJ, Waljee AK, Taylor JR, et al. Endoscopic full -
thickness resection of gastric lesions using a novel grasp -andsnare technique: evaluation in a porcine survival model . Surg
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63 Cho WY , Kim YJ, Cho JY , et al. Hybrid natural orifi ce translu-
minal endoscopic surgery: endoscopic full -thickness resection of
early gastric cancer and laparoscopic regional lymph node dissection – 14 human cases . Endoscopy 2011;43(2):134–9.
64 Raju GS, Malhotra A, Ahmed I. Colonoscopic full -thickness
resection of the colon in a porcine model as a prelude to endoscopic surgery of diffi cult colon polyps: a novel technique (with
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65 Zhou PH, Yao LQ, Qin XY , et al. Endoscopic full -thickness resec-
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tumors originated from the muscularis propria . Surg Endosc
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66 Wang L, Ren W, Fan CQ, et al. Full-thickness endoscopic resec-
tion of nonintracavitary gastric stromal tumors: a novel approach .
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69 Ryou M, Thompson CC. Magnetic retraction in natural -orifi ce
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problem of traction and countertraction . Endoscopy 2009;41(2):
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70 Rieder E, Swanstrom LL. Advances in cancer surgery: natural
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71 Lennard TW , Shenton BK, Borzotta A, Doet al. The infl uence of
surgical operations on components of the human immune
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72 Nau P, Anderson J, Yuh B, et al. Diagnostic transgastric endo-
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74 Voermans RP , Faigel DO, van Berge Henegouwen MI, et al.
Comparison of transcolonic NOTES and laparoscopic peritoneoscopy for the detection of peritoneal metastases . Endoscopy
2010;42(11):904–9.
75 Voermans RP , van Berge Henegouwen MI, de Cuba E, et al.
Randomized, blinded comparison of transgastric, transcolonic,
and laparoscopic peritoneoscopy for the detection of peritoneal
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2010;72(5):1027–33.
76 Jeong SH, Lee YJ, Lee EH, et al. Gastric lymphatic basin dissec-
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77 Cahill RA, Perretta S, Leroy J, et al. Lymphatic mapping and
sentinel node biopsy in the colonic mesentery by natural orifi ce
transluminal endoscopic surgery (NOTES) . Ann Surg Oncol
2008;15(10):2677–83.
78 Cahill RA, Asakuma M, Perretta S, et al. Gastric lymphatic
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79 Yasuda K, Kitano S. Lymph node navigation for pancreatic and
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81 Garcia-Tsao G, Boyer JL. Outpatient liver biopsy: how safe is it?
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88 Cahill RA. Regional nodal staging for early stage colon cancer
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90 Dhar A, Johnson KS, Novelli MR, et al. Elastic scattering spec-
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Training the Surgeon for NOTES
Silvana Perretta , Bernard Dallemagne, & Jacques Marescaux
University Hospital of Strasbourg, IRCAD (Research Institute Against Digestive Cancer), Strasbourg, France
Since its birth in 2004 natural orifi ce translumenal endoscopic surgery (NOTES) has grown slowly but steadily up to
early human trials [1–3]. This evolution has created a new
set of issues and challenges that need to be addressed for
NOTES to move forward, training among these.
“See one, do one, teach one”
“See one, do one, teach one ” is the old axiom often quoted
in this context. It implies that after minimal exposure and
the completion of a procedure once (just once!), you will
have mastered the skill and will be capable of teaching the
next novice. In the minds of many, any deviation from this
streamlined pattern of training is unacceptable and is equivalent to failure. This is a severely fl awed design, certainly
not applicable to a new technique. When a new surgical
concept is established, it usually raises many questions about
its usefulness, appropriateness, applicability, and future. The
development of minimally invasive surgery is a typical
example. Laparoscopic cholecystectomy was the fi rst revolution to shake the surgical community. Belittled in 1987, it
was considered a gold standard in 2002. However, its offi cial
recognition had not helped in avoiding a prohibitive complication rate, with the reported rate of biliary injury being
around 2 to 15 times greater than that of open surgery [4,5].
The Southern Surgeons Club documented a 2.2% incidence
of bile duct injuries for the fi rst 13 cases performed by every
surgeon, whereas for the subsequent patients, the incidence
decreased to 0.1% [6]. The incidence of complications very
clearly depended on the surgeon ’s experience and these
would have a major impact not only on the patient, but on
the medico -legal aspects of surgery [7]. The Royal College
of Surgeons of England made a useful early statement in
1990 as to how training should proceed, and in North
America, the Society of American Gastrointestinal Surgeons
made a statement suggesting guidelines for “credentialing
surgeons” in the performance of laparoscopic procedures
[8]. These events stimulated the surgical community into
redefi ning the way a new technique should be developed
and propagated, and showed them the necessity of developing new methods for education and training. Incorporating
these methods into the traditional educational system and
training of already established surgeons inspired various initiatives based more on the new axiom “see many, do many,
teach many. ”
Natural orifi ce fl exible surgery can be complex, requiring
considerable skill and experience. Untrained individuals run
the risk of misjudging their skills, either attempting less than
they could or – worse – attempting too much and jeopardizing the safety of the very patient they aspire to serve. It
was obvious that the safe clinical use of NOTES depended
on the development of effective training programs and
guidelines.
To avoid some of the missteps and complications that
occurred with the introduction of laparoscopic surgery,
responsible leaders in surgical laparoscopy and gastrointestinal endoscopy addressed the main issues related to NOTES
intervention. Perhaps the most important lesson learned
from the anarchic infancy of laparoscopic surgery is that
these issues should be addressed before widespread introduction of a new technology [9]. Three American scientifi c
societies, the Society of American Gastrointestinal and
Endoscopic Surgeons (SAGES) the American Society for
Gastrointestinal Endoscopy (ASGE), and the Natural Orifi ce
Surgery Consortium for Assessment and Research (NOSCAR),
reacted very quickly by elaborating recommendations for
pre-clinical laboratory training and clinical application of
NOTES [10,11].
According to these guidelines the group who could be
involved in NOTES (i) should have a multidisciplinary team
that possesses both advanced fl exible endoscopic skills and
Natural Orifi ce Translumenal Endoscopic Surgery (NOTES): Textbook and Video Atlas, First Edition. Edited by Anthony N. Kalloo, Jacques Marescaux,
Ricardo Zorron.
© 2012 John Wiley & Sons, Ltd. Published 2012 by John Wiley & Sons, Ltd.
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SECTION 3 Perspectives on NOTES
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laparoscopic skills; (ii) must have supportive laboratory data
on animal model and cadavers prior to approval for performing initial NOTES in humans; (iii) must agree to share laboratory results; (iv) must agree that all human procedures
should be performed after obtaining approval from an Institutional Review Board; and (v) must submit all cases to an
outcome registry that will be maintained by the concerned
scientifi c societies [12].
What comes to the fore is the importance of providing
structured training in these techniques. Ideally the establishment of national and international NOTES training curricula
may solve the problem of providing standardized training.
Such curricula should articulate what NOTES training
should be, which means that we can now clearly assess the
performance of both trainer and trainee and conduct appropriate follow -up of the practitioners who have been trained.
Standardization would also allow training more students
while identifying what NOTES practitioners can safely
undertake at a given level of skill or experience.
In order to structure appropriate training, the fi rst step is
to agree upon what NOTES surgery really is, what it should
look like, and how best to perform it. Nevertheless, today
such a consensus is not easy to achieve. NOTES is a fi eld in
constant evolution and as a consequence there is a patchwork of techniques, tools, and surgical modus operandi.
NOSCAR tried to put order into the semantic chaos inspired
by NOTES by differentiating laparoscopic procedures and
translumenal extraction of specimen from NOTES. A procedure can be labeled NOTES if visualization and signifi cant
dissection is performed using a fl exible endoscope. Location,
site of access and incisions, and number of trocars used
should be clearly described.
NOTES cholecystectomy, the fi rst operation reported in
the literature, is a good example of surgical entropy in
that it is a measure of the disorder, or more precisely the
unpredictability of NOTES practice today. There is no way
to predict what will come next. Both transvaginal and
transgastric approaches are still suffering from a lack of
standardization regarding the operative technique and tools.
In fact, although transvaginal surgery when performed with
rigid instruments is close to a good standardization, as it
relies on known laparoscopic skills and instrumentation
over less familiar endoscopic techniques and less effective
tools, this is not the case for the equivalent fl exible technique. All the cholecystectomies reported in the literature
with a “fl exible ” technique highlighted the limitations
related to the inadequacy of current instrumentation with
the resulting lack of exposure, fi ne dissection, and safe cystic
duct ligation. No two procedures are completely alike – the
location of the entry port varies, as does its distance from
the targeted organ and by consequence the view and
orientation of surrounding tissue. Personal creativity and
technical virtuosity had to fi ll in for the lack of dedicated
endoscopic platforms and tools. As a result, when it comes
to clearly defi ne what should be thought and by whom,
things get murky.
NOTES per se represents an additional educational challenge in a way that engages gastroenterologists and surgeons, two groups with very distinct background, skills, and
personalities. Who, then, should practice NOTES? What
training and in what format should be offered to the one or
to the other? This is really a trivial question if we keep in
mind the basic rules in medicine, primum non nocere. NOTES
should be practiced by the physician who masters the
knowledge of surgical principle, technique, and anatomy.
Then if the operation is performed by means of fl exible
endoscopes and platforms, endoscopic skills should be
required or acquired. Credentialing in the organ of access is
also a fundamental requirement. If the operation is performed by a transvaginal access, a gynecologist should be
part of the team, at least initially.
As very clearly stated by the 2008 NOSCAR working
group, the basic premise is that the practitioner must have
the judgment and training to safely complete the procedure
as intended, as well as the capability of immediately proceeding to a traditional surgical approach when the circumstances so dictate.
Surgeons master surgical principles, technique, and
anatomy, and will need to face only the technical issues
related to the manipulation of the endoscope and the endoscopic tools. Also, a growing number of surgeons are currently performing fl exible endoscopy. Gastroenterologists
have no mastery of surgical principle, technique, and
anatomy. In the best possible scenario, training should
involve a team approach that takes advantage of the unique
skills of endoscopists and laparoscopic surgeons.
Initial training of surgeons and endoscopists in natural
orifi ce interventions should involve laboratory and animal
models. Studies showed that training on animal models
helped to overcome the hurdles laid out by surgery in a new
environment [13–15]. The gradual implementation of the
skills acquired in the laboratory would then allow a more
secure clinical application of the surgical procedures learnt
and the natural establishment of a multidisciplinary team.
Web -based surgical endoscopy simulation of NOTES procedures could also provide an adjunct to standard laboratory
training. The concept of “learning by doing ” becomes less
acceptable when dealing with a new, not yet well standardized, technique. In order to objectively measure knowledge
and skill in laparoscopic surgery, SAGES has developed a
web-based training and verifi cation program called Fundamentals of Laparoscopic Surgery (FLS). FLS is now required
by the American Board of Surgery to become board certifi ed
and is offered to all graduating general surgery residents.
Following the same principle, a fl exible endoscopy training
and testing program, Fundamentals of Endoscopic Surgery
(FES), is now available and is expected to become a benchmark of knowledge and skills. Based on the success of FLS
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CHAPTER 26 Training the Surgeon for NOTES
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and FES, a NOTES skill set assessment tool, Formative Intraoperative Tool for NOTES Evaluation of Surgical Skills ”
(FITNESS) has been proposed.
Dedicated NOTES “box” trainers can be helpful in the
experimental setting, simulating an effective NOTES environment, refi ning experiments before moving on to in
vivo trials, such that the number of animals required for
acquiring basic skills and validating new surgical protocols
can be reduced. Additionally, the simulator has the potential
to be utilized as an effective platform for education and
training [16].
Once the basic skills of NOTES have been attained and the
means are available for supervised practice on animal training models, training courses are important and should also
be available to all surgeons during their training process. A
few NOTES courses are available today. Multiple and varying
teaching methods of these new techniques have been
offered. The IRCAD -EITS in Strasbourg has, since the beginning of 2007, enabled its educational capabilities by offering
training programs in NOTES combining theory and hands on practice.
See many, teach many, do a few . . .
The step from laparotomy to laparoscopy seems obvious
today. Laparoscopy truly revolutionized surgical practice and
patient care. With NOTES we are now confronted with less
obvious immediate advantages, besides cosmesis. Expected
advantages of NOTES relative to infection, hernia, postoperative pain, hospital stay, and time off work are still
only theoretical and have yet to be proven in randomized
controlled trials. Is it worth putting such effort into something that will probably not become mainstream? Is it
worth reshaping surgical and endoscopic training? An
evaluation of the expectations and perspectives of the
IRCAD NOTES training course participants revealed that
50% of them considered NOTES as the next surgical
revolution and that it could potentially be applied clinically
in the next 2 –10 years. In the fi rst year of its establishment,
the dedicated website (www.eats.fr) created under the aegis
of the European Association for Transluminal Surgery
(EATS) had 1700 registered members and more than 85 000
visits. This demonstrates the willingness of physicians when
it comes to acquiring skills that would allow them to integrate easily in an innovating and promising area of surgery,
even in its infancy. Will NOTES truly change the everyday
practice of surgery? It is premature to answer but what is
certain is that the philosophy that NOTES generated is here
to stay. Even if they do not know exactly what is going to
come next, physicians are ready to see many, teach many,
and probably do a few, and seem to be willing to embrace
what might not be a revolution but a natural evolution of
surgery.
Once upon a time we looked with our eyes and operated
with our hands. Today, being less invasive needs to go
further than laparoscopic or endoscopic replications of open
surgical techniques. The idea of decreasing the morbidity of
an operation challenges not only the way the surgery is
delivered but also the surgical strategy itself. Today, the
availability of sophisticated physiology and imaging tests
should permit us to use fl exible endoscopic, laparoscopic,
and perhaps soon even image -guided surgical access to truly
perform minimally invasive and precisely targeted treatments. “No scar ” surgery opened the way to using fl exible
endoscopy to treat gastrointestinal diseases as it does not
require external surgical access and brings the surgeon to
the nearest point to the pathology – minimizing the “collateral damage ” that operating on the gastrointestinal system
typically entails. Already, procedures that in the past were
only performed by radical surgery can now be performed
via endolumenal treatments and fl exible scopes. “Scarless
surgery” with its preservation of the skin ultimately led to
the preservation of the organ. The boundaries between
surgery and endoscopy get thinner as you read. An educated
guess would be that the foregut surgeon who loses the
opportunity to learn and practice endoscopy will soon
disappear. What is clear today is that fl exible endoscopy
should be part of a surgeon ’s background and of the armamentarium available in the operating room. Therefore, it is
wise to take a step back and have more realistic expectations, bringing fl exible endoscopy into the surgical routine
and training program while preparing for a future NOTES
fellowship and for the development of dedicated tools. It is
vital that dedicated programs to develop advanced endoscopic skills are put into practice in medical education curricula and postgraduate surgical training. This will ensure
maintenance and improvement in the quality of patient
care. Modern surgery will need leaders with endoscopic
skills that are well defi ned, and its success will be determined by how quickly, effectively, and, most importantly,
safely we learn and adapt.
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Simulator -based Training
of NOTES Procedures
Kai Matthes,1Ganesh Sankaranarayanan,2Woojin Ahn,2& Suvranu De
1
Beth Israel Deaconess Medical Center and Children ’s Hospital Boston, Harvard Medical School, Boston, MA, USA
2
Rensselaer Polytechnic Institute, Troy, NY, USA
Introduction
NOTES is still early in its development, having been fi rst
described in an animal model in 2004 and most publications
still resulting from animal studies [1]. There are, however,
a number of human case reports and a handful of case series
presently [2–4]. The vast majority of human case reports are
hybrid NOTES procedures, with laparoscopic ports for visualization, retraction, and technical assistance. Some NOTES
procedures involve the use of rigid laparoscopic instruments,
while others use fl exible endoscopic instruments. Procedures in the upper abdomen may be performed using rigid
instruments through a transvaginal or transcolonic approach.
The use of a per -oral transgastric approach requires the use
of fl exible endoscopes with fl exible equipment.
Clinical Interest in NOTES simulation
There has been growing interest among surgeons, gastroenterologists, and industry regarding the development of
NOTES as a surgical alternative. For example, in a recent
survey distributed to general surgeons, 72% of responding
surgeons were interested in becoming trained in NOTES,
representing a great degree of interest in the fi eld [5].
As one may have expected, respondents with minimally
invasive surgery (MIS) specialization and less than 60
years old had increased interest in training in NOTES [5].
Of the responding surgeons, 44% revealed that they would
perform NOTES rather than laparoscopic cholecystectomy if
NOTES were feasible, NOTES were an available modality in
their hospital, and the surgeons were trained. Of the surgeons who responded that they would not prefer NOTES
2
cholecystectomy over laparoscopic cholecystectomy, the vast
majority (88%) noted that they would change to a NOTES
procedure if there were suffi cient data to demonstrate
improved outcomes compared to the standard of care [5].
With the onset of any new technique, caution must be
exercised in the adoption of techniques that have little
human experience or long -term follow -up. In the case of
NOTES, there are certain unique aspects that require perhaps
even more caution, such as the expertise in multiple skill
groups (minimally invasive surgery and fl exible endoscopy).
This further underlines the importance of proper education
and training, for which simulator training will play an even
more important role in the future. Some have argued that
laparoscopic cholecystectomy was introduced by surgeons in
a less than orderly fashion that did not optimize safety and
training. There must be caution in the adoption of NOTES
technology in humans without adequate training and experience in animal models and simulations. Surgeons and/or
teams that attempt to perform NOTES procedures without
adequate training are more likely to have poor results,
which may result in patient harm and may hinder the development and adoption of this new technology [6].
With an eye towards this, the Natural Orifi ce Surgery
Consortium for Assessment and Research (NOSCAR) was
created by a joint initiative of the leaders of the Society of
American Gastrointestinal and Endoscopic Surgeons
(SAGES) and the American Society of Gastrointestinal
Endoscopy (ASGE). In 2006, NOSCAR published a White
Paper addressing important considerations for conducting
NOTES research and provided recommendations for the
clinical development and implementation of NOTES. The
consortium also directs funding for NOTES research and
created an international registry for human NOTES
procedures.
Natural Orifi ce Translumenal Endoscopic Surgery (NOTES): Textbook and Video Atlas, First Edition. Edited by Anthony N. Kalloo, Jacques Marescaux,
Ricardo Zorron.
© 2012 John Wiley & Sons, Ltd. Published 2012 by John Wiley & Sons, Ltd.
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Skills sets of NOTES training
Simulation of translumenal access
Using a translumenal approach, the abdominal cavity is
accessed with fl exible endoscopes or rigid laparoscopic
instruments through an incision in the stomach, colon, or
vagina, which may be created with various endoscopic,
laparoscopic, or surgical techniques. Translumenal access is
associated with a risk of injury of adjacent organs, particularly in a non -hybrid procedure with lack of visualization of
the access procedure. This level of diffi culty should be adequately simulated in a model that trains the physician to
overcome limited visualization and to identify landmarks
after accessing the abdominal cavity through different translumenal sites.
Simulation of transgastric access
A transgastric approach to the abdominal cavity is commonly performed using a fl exible endoscope and fl exible
endoscopic instruments operated through the working
channel of the scope. The advantage of choosing the stomach
as an entry point is that organs in the lower abdomen such
as the appendix or the ovarian tubes can be accessed in a
direct straight fashion. Surgical sites in the upper abdomen
are more diffi cult to access since certain locations distant
from the access port, for example the gallbladder, are diffi cult to reach without a shape -lock device. Retroversion of
the endoscope allows areas to be accessed if they are located
adjacent to the gastric incision. Some multiplatforms with
shape-lock technology or additional bending sections may
help to overcome this limitation.
For transgastric NOTES, trainees should be trained using
a simulation model to operate a fl exible endoscope and to
perform the translumenal incision using guidewires, controlled radial expansion balloons, sphincterotomes, and
needle-knives. Part of the simulation should be to provide
experience on how to detect and manage injuries to adjacent
organs such as liver, spleen, pancreas, colon, or small bowel.
Clinically, these injuries may be undetected and can lead to
infection or hemorrhage, resulting in high morbidity and
mortality. To prevent these injuries, the transillumination
technique will help the trainee to verify that no adjacent
organs are on the other side of the stomach wall at the incision site. Potentially simulation models may also use endoscopic ultrasound (EUS) to avoid injury of adjacent organs.
Using linear ultrasound, a guidewire may be introduced
safely into the abdominal cavity using this technique and
then combined with a sphincterotome incision and/or controlled radial expansion (CRE) balloon dilatation. Currently
ex vivo models provide the possibility of EUS simulation.
Simulation of transvaginal access
Currently, the transvaginal access is most frequently used
for human studies based on the fact that the closure of a
vaginal incision has proven to be safe for gynecologic procedures in the past. Also in available ex vivo simulation
models, a manual closure of the incision site may be
performed.
Rigid instruments can be used to operate in the upper
abdomen for cholecystectomy or nephrectomy, for example.
If rigid instruments are used, the simulation model should
allow the trainee to become familiar with the standard laparoscopic approach before attempting NOTES. If fl exible
instruments are used, the trainee should learn the use of
advanced interventional endoscopy equipment before using
these instruments for abdominal surgery.
Simulation of transcolonic or
transanal/TEM access
The group of Meining et al. demonstrated an innovative
method for creating a transcolonic access by using a
specially designed guide tube, which is inserted via a transcolonic approach into the abdominal cavity after intraperitoneal instillation of a decontamination solution through a
Veress needle in the umbilicus. The solution provided an
artifi cial ascites level in the abdomen with the bowel loops
fl oating on top of the fl uid that collected in the pelvis by
positioning the patient in 30 ° reverse Trendelenburg. After
verifying a clear space on the opposite side of the colon by
using an endolumenal ultrasound probe (10 MHz) inserted
transanally, abdominal access was obtained with a transanal
endoscopic microsurgery (TEM; Karl Storz, Tuttlingen,
Germany) device by advancing a trocar through the colon.
Following the procedure, the access site was closed with a
purse string suture that was placed before entering the
abdominal cavity in addition to one or two applications of a
linear stapler [7]. Other investigators used a needle -knife in
addition to the TEM or simply a double -channel colonoscope to enter the abdomen. Bacterial contamination of the
abdomen with colonic bacteria is certainly the biggest
concern of this NOTES approach and requires special considerations and further clinical testing. Using simulation,
trainees can be supervised by experts to identify potential
sources of infection during transcolonic access, which may
be overseen in a clinical setting with less possibility of
observation.
Using simulation, trainees should be made familiar with
the use of the TEM device or how to operate a double channel colonoscope on the simulator. Alternatively, rigid
laparoscopic instruments may be used to access the right or
left upper quadrants of the abdomen. Here, laparoscopic
pre-experience with the standard approach is required
before attempting NOTES.
Simulation of transvesical access
The group of Lima et al. [8] demonstrated the feasibility of
using the bladder as a translumenal access point. The use of
this technique is limited by the small size of endoscope that
would fi t through the urethra. However, advantages of this
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technique are the applicability for both genders, the avoidance of the colon with more harmful bacterial fl ora, and
sterile conditions of the bladder with presumably smaller
risk of abdominal infection in the setting of closure
insuffi ciency.
The creation of transvesical access requires urological
experience on how to perform vesicoscopy. Ex vivo models
are available that allow performance and training of transvesical access.
Surgical procedures
Simulation of adequate visualization
Proper visualization of anatomical structures is of utmost
importance to safely perform minimally invasive surgery.
The light source of fl exible endoscopes provides only
limited illumination of the abdominal cavity since they
are designed to illuminate smaller lumens such as the
stomach or the colon. The light source can be adjusted
manually, but with a change of scope orientation the illumination may be too strong if the scope is operated closer
to the organ wall, leading to refl ection of the light and
glaring the optical lens. These limitations of visualization can
be appropriately simulated in current NOTES models and
can train the operator to appropriately illuminate structures
while operating.
Meticulousness is required to examine all structures and
to verify that the correct structures are identifi ed and dissected. This requires certain expertise of the trainee and
some training to manually adjust the light source as needed.
Simulator training may be suffi cient to obtain this level of
expertise before proceeding with live animals.
Simulation of tissue dissection
As indicated above, the identifi cation of correct anatomical
structures is absolutely necessary to perform NOTES safely.
Tissue dissection can be simulated using artifi cial or ex vivo
tissue with fl exible endoscopic instruments such as forceps,
graspers, endoscopic scissors, and the needle -knife. Blunt
dissection with a fl exible endoscope is different from laparoscopic instruments and requires excellent endoscopic skills,
which should be acquired in a simulator or in a live animal
before proceeding with humans. Especially the use of endoscopic scissors or needle -knives requires advanced endoscopic experience. If a needle -knife is used to dissect large
vessels such as the renal artery or the splenic vein, minor
unintentional movements of the tip of the endoscope, which
can result from releasing one of the wheels of the endoscope, can move the needle -knife a few millimeters laterally,
potentially resulting in laceration of arteries and veins.
Simulation of rigid versus fl exible operation
Depending on the background of the “digestivist” performing NOTES, either fl exible or rigid instruments may be
chosen in accordance with the preference and clinical back-
ground of the surgeon or gastroenterologist. Flexible instruments are required for the transgastric access route, but
transcolonic or transvaginal procedures are amendable to
rigid instrumentation.
Using rigid instruments requires little adaptation of the
surgeon to perform NOTES. If fl exible endoscopes are
required and the physician is not performing fl exible endoscopy on a daily or weekly basis, additional skills need to be
acquired to gain profi ciency in this technique before advancing to humans.
The use of NOTES simulators can help to overcome lack
of experience with one technique versus the other.
Simulation of retraction
Retraction of organs and structures is important to perform
surgical procedures, but more challenging if the procedure
is performed using a NOTES approach. The lack of triangulation provides a challenge since retracting instruments exit
the endoscope parallel to the imaging source and the dissecting device.
The NOTES approach with limited retraction possibilities
provides a challenge to both gastroenterologists and minimally invasive surgeons. To overcome poor retraction and
visualization, trainees may undergo simulation training followed by live animals to adjust to the different circumstances in comparison to standard laparoscopy.
Simulation of tissue ligation
A ligation of vessels and other structures can be achieved
endoscopically with endoloops (Olympus America, Inc.,
Center Valley, PA, USA). However, the ligating force of these
endoscopic devices is probably not comparable to a surgical
suture or a laparoscopically placed ligation. If rigid instruments are chosen, standard laparoscopic conditions apply,
overcoming the limitations of endoscopic devices.
Interventional endoscopy skills are required for the trainee
to learn how to effi ciently ligate structures with fl exible
endoscopic devices. The ligation of the appendix using a
NOTES approach is not much different from a ligation of a
large pendunculated polyp. The uterine horn has been
reported as a simulation model for appendectomy since pigs
do not have an appendix [9].
Simulation of clip application
Endoscopic clips may not provide the safety of laparoscopically applied surgical clips, as the strength of the smaller
nitinol clips is not comparable to surgical clips.
Using simulation models, the trainee should understand
the limitation of using commercially available clips for fl exible endoscopy and use them with caution for hemostasis or
the clipping of ducts. Insuffi ciency of clip application on the
cystic duct after cholecystectomy would result in potentially
dangerous but avoidable consequences.
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Simulation of organ or specimen retrieval
The retrieval of organs after NOTES resection such as, for
example, the appendix, the gallbladder, or the kidney can
provide challenges dependent on the size of the organ.
Retrieving the appendix does not appear to be challenging,
but a transvaginal retrieval of the gallbladder, or even the
kidney, could lead to rupture of the gallbladder with spillage
of bile or to a laceration of the access organ complicated by
hemorrhage or postoperative infection.
The retrieval of organs through a natural orifi ce should be
practiced in simulation models or live animal before it is
performed in humans. Observing the exit of the organ
through the access organ with laparoscopy may provide
additional safety in human procedures.
Closure of access site
The most propagated concern about NOTES appears to be
the safety of closure of the translumenal access point. The
closure of a transvaginal access port may be less critical
since the bacterial fl ora of the vagina is rather benign and
unlikely to lead to a signifi cant infection of the abdomen.
However, with transgastric or transcolonic access the effi ciency of closure is of utmost importance due to the increased
potential of an intra -abdominal infection in the setting of
closure insuffi ciency. When providing peri -operative care
for patients undergoing NOTES procedures, signifi cant
abdominal discomfort, tenderness, or clinical signs of
infection may point toward a complication in relation to
the translumenal closure. The closure of the access site
may be performed with endoclips applied laparoscopically
in a hybrid approach or endoscopically using clips used
for endoscopic hemostasis. The latter technique does not
appear to be safe to close a stomach incision as the
strength of adaptation of the incision wall is questionable
and cannot be considered safe. Recently, clips using an
over -the-scope technique appear to be more promising
since they provide a stronger adaptation force. Special
closure devices using suction are available and have been
investigated. Ultimately, the safest closure may be by using
surgical staplers or hand -sewn closure of the access site in
the sigmoid or the vagina. All closure techniques can be
well simulated with ex vivo models or live animals. Real
tissue provides the advantage of a realistic haptic feedback
when placing sutures and the advantage to test adequate
closure with leak testing by submerging the infl ated specimen under water.
Management of intra-abdominal hemorrhage
One of the challenges of providing anesthesia for NOTES
procedures would be the limited knowledge or experience
with unexpected complications. A pure NOTES approach
implicates minimally invasive surgery with fl exible endo-
scopic devices that are generally not designed for this particular purpose. Some devices used for intra -abdominal
surgery are designed for the endolumenal use of interventional gastrointestinal (GI) endoscopy. In the setting of vascular injury during a non -hybrid NOTES procedure, the
ability to achieve hemostasis is limited by lack of access and
functionality of fl exible endoscopic devices. This may result
in an unexpected blood loss and a potential conversion to
laparotomy if hemostasis cannot be achieved endoscopically.
Even in NOTES centers with research experience, surgeons
still operate at the steep part of the learning curve. The
management of unexpected complications may challenge
even experienced surgeons. A limited visualization of the
abdominal cavity with fl exible endoscopes could lead to
minor bleeding being unrecognized as the source may be
hidden behind other structures.
With the current standard of endoscopic devices used for
NOTES, there is limited ability to treat a major vascular
injury. In the setting of a signifi cant intra -abdominal hemorrhage, transabdominal laparoscopic ports may need to be
inserted or a laparotomy performed. Due to the lack of suffi cient expertise with this emerging surgical technique,
anesthesiologists have to be prepared for a major blood loss
even with minor procedures such as a transvaginal cholecystectomy or appendectomy. This is mainly based on the
fact that surgeons operate on the steep part of the learning
curve when performing NOTES. Due to anatomical differences, research experience in the animal laboratory cannot
compensate for experience with human cases. NOSCAR
strongly discourages surgeons interested in NOTES to
advance to human application too quickly. Especially the
establishment of translumenal access is different from
current laparoscopic procedures. With the access of the
abdominal cavity adjacent organ structures may be injured.
There may be a time delay until suffi cient visualization of
the peritoneal cavity is accomplished, and there may be a
lack of visualization of the entire abdominal cavity, which
may lead to signifi cant hemorrhage being detected late or
not at all. Proper surgical ligation of major vessels may take
longer than expected in comparison to standard laparoscopic
or open procedures.
The appropriate simulation of intra -abdominal hemorrhage is limited in current NOTES simulators based on the
absence of blood fl ow and tissue perfusion. However, using
the Erlangen Active Simulator for Interventional Endoscopy
(EASIE) models, hemorrhage can be simulated by splenic
arteries sewn into the lumen of the GI barrier or other
organ structures [10–13]. These splenic arteries are connected to a blood circuit that delivers artifi cial blood with a
roller pump. Common endoscopic and laparoscopic techniques can be simulated with this bleeding scenario by
suturing vessels in the GI wall or organ structures close to
the access site (Figure 27.1).
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