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SECTION 1 Development of the NOTES Concept
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infections as defi ned by decreased oral intake and inappropriate social behavior. Interestingly, only one control animal
showed macroscopic evidence of infection at necropsy. In
this well -designed study, the authors demonstrated that
there is signifi cant decrease in the intra -abdominal bacterial
burden when pre -operative doses of antibiotics and
antibiotic-infused gastric washes are completed. However,
they found no difference in the rate of microscopic or macroscopic peritonitis between the two study arms.
Other groups have performed similar investigations
into the role of gastric irrigation and antibiotic prophylaxis.
Giday et al. published a manuscript in which they compared
a sterile transgastric procedure with prophylactic perenteral
antiobiotics to one without any pre -procedure prophylaxis
[27]. They found that there were signifi cantly more positive
intraperitoneal cultures and abscesses when comparing
the control to the treatment groups. A study completed by
McGee evaluated the infl uence that high - and low -volume
lavages had in comparison to an antibiotic
[28]. They found no signifi cant differences in the number
of abscesses formed between the three groups. Furthermore,
gastric cultures taken following lavage were similar for
the three study arms. At necropsy, 44.4% of animals had
positive peritoneal cultures and 61% had some degree of
infection. However, there was no difference in the prevalence of infection or positive cultures between the three
groups.
In reviewing the available literature investigating the risk
of infection from a transgastric approach, little can be determined with any degree of confi dence. It is clear that the
stomach effl uent is contaminated. Furthermore, the amount
of contamination can be directly infl uenced by the level of
acidity of the gastric contents [29]. This bacterial burden is
most likely associated with the cross -contamination of the
peritoneal cavity during per -oral passage of the endoscope.
However, the clinical signifi cance of a lavage of the stomach
remains unclear. Additionally, the role that an antibiotic containing lavage plays has not been adequately described.
Perhaps the most important question, however, is how to
translate this animal data into protocols completed in human
subjects.
-enriched lavage
Human data
A review of the animal research in the fi eld of transgastric
natural orifi ce surgery yields mixed results. While some
have shown that the clinical signifi cance of this technique
is negligible, others have found that this approach exposes
the patient to undue operative risks. However, the question
of whether this information translates to a human model
remains.
In an effort to address these concerns, Hazey et al. designed
a series of experiments in humans to determine what level
of bacterial contamination occurs secondary to the transgastric passage of the endoscope [30–32]. Through their studies
they sought to address the clinical signifi cance of this bacterial load. In each case, a pre -operative dose of prophylactic
antibiotics was administered (2 gm IV Cefazolin or 600 mg
Clindamycin and 90 mg Gentamicin in the event of a penicillin allergy). All patients were fasted for twelve hours prior
to surgery. At no point was the stomach irrigated in an
attempt to decontaminate the gastric effl uent. To quantify
the bacterial load, aerobic and anaerobic plate counts were
carried out using the spread plate method. Following a
standardized incubation period, the colonies were counted
and species identifi cation performed using the Biolog MicroStation™ system. All patients were followed for thirty days
to assess for late infectious complications. In each case, the
scope was cleaned with gluteraldehyde, but was not considered sterile.
The initial experiment evaluated the infectious implications of the creation and manipulation of an open gastronomy in fi fty patients undergoing laparoscopic Roux -en-Y
gastric bypass (LSRYGB) without an associated NOTES procedure [30]. In this study, three distinct samples were collected. The fi rst was a gastric aspirate prior to gastrotomy.
The second was a sample from the peritoneal cavity prior to
jejunojejunostomy and gastrotomy creation. The third
sample was taken from the abdomen after completion of
the jejunojejunostomy and gastrojejunostomy. The mean
number of colony forming units (CFU) in the gastric samples
collected was 22 303CFU/ml. Samples taken from the
abdominal cavity prior to gastrotomy creation showed no
CFUs in 44 of 50 patients (88%). The mean bacterial counts
in the postprocedure peritoneal samples were 1102 CFU/ml.
There was signifi cantly more bacterial contamination in
the gastric aspirate than in either of the peritoneal samples
(p < 0.01). In only fi ve cases was cross -contamination
of gastric fl ora into the peritoneal cavity documented.
There were no infectious complications in this cohort of
patients.
In the second study, the baseline contamination of the
endoscope was assessed [31]. Further, the role that the
endoscope played in contaminating the abdomen secondary
to its transgastric route was evaluated. In this case, the
experiment was completed in ten patients undergoing transgastric peritoneoscopy for the staging for pancreatic masses.
To assess the baseline level of scope contamination, a sterile
wash was collected from the unused gastroscope prior to its
introduction into the oropharynx. To evaluate the bacterial
load of the peritoneal cavity prior to a NOTES procedure,
saline was infused laparoscopically, agitated, and then
removed. Finally, to measure the level of contamination
present due to the per -oral passage of the endoscope, saline
was introduced laparoscopically following transgastric
passage of the endoscope, agitated, and collected. Prior to
scope introduction, sterile washes of the endoscope yielded
an average of 132.2 CFU/ml. No bacteria isolates were identifi ed from these samples. Abdominal cavity aspirates taken
32
CHAPTER 4 Infection Control in NOTES
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prior to gastrotomy grew on average 160.4 CFU/ml. No bacterial species were isolated from these samples either. In the
post-gastrotomy aspirates, 642.1 CFU/ml were identifi ed.
This value was not signifi cantly different from the pre procedure samples ( p = 0.5). In fi ve cases, post -gastrotomy
peritoneal washings had either a streptococcal species (4) or
Escherichia coli (1) identifi ed. Cross -contamination was not
observed. There were no immediate or delayed infectious
complications in this cohort.
The last experiment performed by Hazey et al. assessed
the incidence of cross -contamination during a true NOTES
procedure in forty patients scheduled to undergo LSRYGB
[32]. In each case, prior to laparoscopy, the peritoneal cavity
was accessed from a transgastric approach and an exploratory peritoneoscopy competed. The scope was then withdrawn and the gastrotomy used for anvil insertion used for
creation of the gastrojejunostomy. For the purposes of this
experiment, cross -contamination was defi ned as the presence of gastric fl ora in the postprocedure peritoneal cavity.
Having passed the gastroscope into the stomach, sterile
saline was infused through the therapeutic channel into the
gastric lumen, agitated, and collected with the suction port
of the endoscope. Following gastrotomy creation and transgastric passage of the endoscope, an endoscopic peritoneoscopy was performed. Next, laparoscopic ports were placed
and sterile saline was infused laparoscopically into the peritoneum, agitated, and collected. The median level of bacteria
present in the gastric aspirate was signifi cantly higher than
the post -gastrotomy peritoneum (980 versus 320 CFU/ml,
p = 0.001). Cross -contamination was documented in 21%
of the cases. However, there were no infectious complications in this population.
In an effort to describe the signifi cance of the use of
proton pump inhibitors (PPIs) pre -operatively, a subset analysis was performed in the fi rst and last experiments. Of the
fi rst group of fi fty patients who underwent LSRYGB without
a concomitant NOTES procedure, seventeen were taking
PPIs. In this group, the use of PPIs correlated with a statistically signifi cant increase in the median bacterial load found
in the stomach when compared with those individuals not
taking PPIs (33 000 versus 0 CFU/ml, p = 0.018). However,
PPI use did not translate to an increase in the peritoneal
bacterial load after completion of the anastomoses. In the
last experiment, fi fteen of the forty patients were on PPIs.
These individuals had signifi cantly higher bacterial counts
than those not on PPIs ( n = 25) (7 800000 versus 340 CFU/
ml, p
= 0.01). The use of PPIs did not translate to a higher
bacterial load in the peritoneal cavity after transgastric
passage of the endoscope (500 versus 300 CFU/ml, p = 0.1).
Clearly, the increased gastric pH associated with the use of
PPIs creates an environment that is conducive to bacterial
growth and proliferation; however, this increase does not
correlate with an increased infectious risk to the patient after
transgastric peritoneoscopy.
Summary
Much like the transvaginal approach to accessing the
abdominal cavity, transgastric NOTES is not without its limitations. There is still no safe, reproducible means for closure
of an endoscopically fashioned gastrotomy. Further, working
platforms facilitating procedures in the abdominal cavity
require additional development. With that said, a review of
the available human research investigating the infectious
implications of the transgastric passage of an endoscope into
the abdominal cavity should not discourage further development of this technique. It is clear that there is contamination
of both the endoscope and gastric effl uent. Moreover, the
use of gastric pH modulating agents such as PPIs may
increase the bacterial load within the stomach. However,
this does not appear to correlate with an increase risk of
infection within the peritoneal cavity based on these initial
results.
Transcolonic
Given the wealth of knowledge in the endoscopic approach
to the diagnosis and treatment of colorectal pathology, it is
not a surprise that the colon was initially identifi ed as a
potential route through which the abdominal cavity could
be approached. Transanal endoscopic microsurgical techniques have been described for rectal tumors for decades.
This technique results in the entrance to the peritoneal
cavity as often as 3.5% of cases, but without an increased
risk for surgical or infectious complications [33]. A modifi ed
natural orifi ce approach has been described in humans for
the removal of left -sided colonic and rectal tumors [34,35].
The colon is an organ that provides for access to both the
peritoneal cavity and the retroperitoneal space. Further, its
natural course through the abdominal cavity affords the
endoscopic surgeon the ability to complete foregut, midgut,
and even hindgut procedures. This can be accomplished
without the need for a cumbersome retrofl exion of the
colonoscope. Much like the gastric or vaginal technique,
however, it is not without its own drawbacks. The colon has
much less tensile strength than the stomach, making a longitudinal injury during endoscopic procedures more likely.
However, perhaps more important is the signifi cant bacterial
burden and the corresponding risk of infection that is associated with the transcolonic passage of an endoscope.
Animal data
In contrast to the thorough and well -designed research that
has been conducted in animals to investigate the infectious
risk of a transgastric or transvaginal procedure, the majority
of the available literature addresses the potential operations
that can be completed from a colonic approach and not its
infectious implications. For this reason, making unambiguous conclusions relating to the infectious implications of a
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transcolonic NOTES procedure is not feasible. However, each
investigation can be interpreted as a standalone analysis into
the risks of a transcolonic natural orifi ce procedure.
Two studies have evaluated the ability of a porcine model
to heal a colotomy created endoscopically. Inherent in this
assessment is the evaluation for any infectious complications. In an experiment by Matthews and associates, eight
animals underwent transcolonic NOTES peritoneoscopies
[36]. In this cohort, pre -procedure water enemas and
antibiotic-infused enemas were completed. The operative
sites were prepped and draped in a sterile fashion and high level disinfection was performed of all surgical instruments.
Colotomies were closed with endoloops (5) or with endoclips as adjuncts to an endoloop closure (2) or a standalone
method (1). Following a seven -day survival period, necropsies were performed and incision sites harvested for microscopic evaluation. Macroscopic inspection found no evidence
of peritoneal contamination. On microscopic analysis, one
pig had transmural necrosis and another had necrotic adventitia beneath a transmural ulceration. In the one animal with
closure using endoclips only, the microscopic assessment
found no continuity in the granulation tissue. In the other
study, completed by Raju et al., four animals underwent
endoscopic colotomies with subsequent closure via endoclips [37]. Pre -procedure colonic preparation pills were
administered and daily intravenous antibiotics were administered in all cases. At necropsy there were no cases of gross
peritoneal contamination. Histologic analysis yielded
mucosal ulcers (75%), but with evidence of healing, including granulation tissue bridging the colotomy.
In contrast to the transvaginal and transgastric approaches,
the transcolonic route provides for direct access to the retroperitoneal space. Three groups have described their varied
experiences with the incorporation of a retroperitoneal procedure from a transcolonic approach in porcine models.
Bazzi et al. developed a protocol for a transcolonic NOTES
nephrectomy [38]. Ramamoorthy et al. described the creation of an endoscopic tunnel in the retrorectal space, allowing for entrance into the peritoneal cavity [39]. Ryou et al.
described a combined transvaginal and transcolonic procedure during which the retroperitoneum was entered to complete a pancreatectomy [15]. In only two cases were the
animals not euthanized following procedure completetion
[15]. In these experiments, tap water enemas, intravenous
prophylactic antibiotics, and antibiotic -infused irrigation
were all completed. On necropsy, no gross evidence of peritoneal contamination or abscesses at the transcolonic access
sites were identifi ed.
The majority of transcolonic protocols to date have concentrated on the completion of peritoneal procedures. Often
these experiments are performed in an acute setting and
cannot provide any information on the potential infectious
implications of their new procedure [40–42]. Others have
described transcolonic peritoneoscopies, cholecystectomies,
and even bowel resections [43–46]. In each study a prophylactic dose of cephazolin was administered. In one study,
anaerobic coverage was added with a supplementary dose
of metronidazole [43]. Further preparation of the colon was
accomplished with a colon prep consisting of normal saline.
In two studies additional washes of cephazolin -infused
normal saline and povidone -iodine were completed in an
effort to further cleanse the rectum and distal colon [44,45].
Following a predefi ned survival period, the animals were
sacrifi ced and necropsies performed. Of the eighteen animals
included in the four aforementioned studies, seventeen survived without complication to the scheduled necropsy date.
The one animal that did not was sacrifi ced early due to
concerns of intra -abdominal sepsis. On exploration, the colotomy was not completely closed, resulting in a colonic leak.
In this study, the defect in the colon was reapproximated
using endoclips [44]. Histologic analysis was completed in
three of the four studies [43–45]. Dubcenco and colleagues
noted normal appearing mucosa with evidence of full thickness healing. In each of their four animals, the colotomy was closed using endoclips only [43]. The other two
studies completed by Pai et al. and Fong et al. both noted
microscopic ulcerations and micro -abscesses on histologic
analysis [44,45]. A variety of closure methods were
employed, including endoclips, endoloops, and a proprietary
closure device. These techniques had no infl uence in the
microscopic outcomes in these studies.
Wilhelm and associates identifi ed the previously described
transcolonic methodology for establishing access to the
abdominal cavity as having a prohibitively high risk of infection and injury to surrounding structures [47]. In response
to these criticisms, they developed a protocol during which
a fl uidoperitoneum was created using a Veress needle prior
to colotomy creation for bowel protection. Then, a sterile
overtube was used for endoscope introduction in an effort
to decrease infectious complications from cross -contamination
of colonic fl ora into the peritoneal cavity. As was the case
in previous studies, prophylactic antibiotics and aggressive
colonic irrigation was completed. The fl uidoperitoneum was
removed prior to fi nishing all experiments. Necropsies performed ten days postprocedure showed no evidence of
injury to surrounding organs. Moreover, histopathologic
analysis showed abacterial chronic infl ammation. No micro abscesses or ulcerations were described.
Human data
Given the morbidity of an uncontrolled perforation and the
subsequent contagion released into the abdominal cavity,
there have been no surgeries completed using a transcolonic
approach in a human model to date.
Summary
Given the wealth of experience in the fi eld of diagnostic and
therapeutic lower gastrointestinal endoscopy, the inclusion
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CHAPTER 4 Infection Control in NOTES
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of this approach into a NOTES protocol is a natural extension in the fi eld. Animal experiments completed to date
have had mixed results. Some have noted well -healed anastomoses without evidence of infection or poor mucosal
approximation. However, others have described microscopic
abscesses and improperly sealed colotomies resulting in
intra-abdominal sepsis. Given the morbidity and mortality
of an uncontained colonic perforation, these results preclude
the design and execution of a transcolonic protocol in a
human model at this time. It is essential that emphasis on
innovation in platform development continue so that this
approach may some day be transitioned to a human model.
Transurethral
The emphasis for minimally invasive techniques in the fi eld
of urology dates back to 1806 with Philip Bozzini ’s transurethral diagnostic endoscopies performed using an aluminum
tube lit by candlelight. The fi rst natural orifi ce procedure
performed in the modern era utilizing the urogenital tract
entailed a transvesicular peritoneoscopy [48]. Since that
time, hybrid and standalone procedures have been described
for prostatectomies and nephrectomies in animal models. In
a human population, experiments have been limited to a
single transurethral peritoneoscopy performed under laparoscopic guidance.
Notwithstanding the dearth of NOTES research from a
transurethral approach, the technique remains appealing
from an infection risk perspective. The urogenital tract is
considered sterile and therefore does not pose the risk of
seeding the peritoneal cavity with normal bacterial fl ora
during to scope passage. This is perhaps best supported by
the absence of a steadfast recommendation for the routine
use of antibiotic prophylaxis during ambulatory urethrocystoscopy. In particular, two randomized trials evaluating a
single intravenous dose of prophylactic antibiotics prior to
transurethral cystoscopy noted no difference in the rate of
positive urine cultures postprocedure [49,50]. To date, no
NOTES protocols have addressed the infectious implications
of a transurethral approach. Nevertheless, assuming that the
cystocope can be adequately sterilized, the infectious risk of
accessing the peritoneal cavity through the urogenital
approach should be negligible. It is clear there are numerous
and varied barriers to the expansion of transurethral NOTES
procedures. However, risk of infection should be considered
clinically insignifi cant and should not deter further
investigation.
Transmediastinal and transthoracic
Given the proximity of the mediastinum and thoracic cavity
to the esophagus and the propensity for a myriad of pathol-
ogy to present in the region, a transesophageal mediastinoscopy and thoracoscopy are natural additions to the fi eld of
natural orifi ce procedures. A mediastinal exploration has
sensitivity and specifi city of 78% and 100%, respectively,
when performed through a cervical incision [51]. It is,
however, limited to the paratracheal and anterior subcarinal
nodes. The potential for accessing the posterior or even
anterior mediastinum for a diagnostic or therapeutic intervention will continue to drive investigation in this fi eld.
Moreover, the ability to attend to diffi cult thoracic pathology
that cannot be addressed thorascopically could potentially
preclude an unnecessary thoracotomy and the associated
procedure-related morbidities. Due to the morbidity of a
defect created in the esophagus, all of the research conducted to date has been completed in animal models. Furthermore, as was the case in the transcolonic trials, much of
the research has been in the mold of a proof of concept
report. Due to this fact, the infectious implications of this
technique must be inferred based on the token reports available in these papers.
Animal data
The ability to completely explore the posterior mediastinum
through a transesophageal approach is an essential characteristic of a NOTES procedure. With this in mind, a group
out of the Mayo Clinic in Rochester developed a technique
for transesophageal mediastinal explorations in a porcine
model using a standard gastroscope [52]. In four animals the
esophagus was irrigated with normal saline washes followed
by a 10% solution of povidone -iodine. Following a mediastinal exploration, the animals were given seven days of
prophylactic intravenous enrofl oxacin. At necropsy fourteen
days later, necropsies were performed. In no case was any
evidence of infection noted within the posterior mediastinum or the esophageal myotomy [52].
Turner et al. investigated the use of an esophageal stent
to seal the esophageal myotomy in ten animals 10 cm from
the gastroesophageal junction [53]. Each pig was given pre operative doses of intravenous clindamycin as well as six
postoperative doses of oral clindamycin. No esophageal of
pharyngeal washes were performed. Following a fourteen day survival period, the animals were sacrifi ced and necropsies performed. No gross mediastinal contamination or
abscesses were noted. Histologic analysis showed complete
mucosal healing in 100% of non -stented pigs and 20% of
those that were stented.
Using a similar technique as the Mayo Clinic group and
Turner, Gee et al. performed transesophageal mediastinoscopies and thoracoscopies using a porcine model [54]. In
four animals mediastinoscopy provided for excellent visualization of all critical structures. In three pigs, thoracoscopies
provided for adequate visualization pleural and intrathoracic
structures. Survival times for this experiment were eight
(two animals) and twelve (two animals) days. All animals
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survived to the predetermined sacrifi ce days without complication. Pre -procedure intravenous cephazolin and betadine washes of the esophagus were performed. They noted
a single abscess in the submucosal esophageal tunnel despite
endoclip reinforcement.
Fritscher -Ravens and colleagues successfully completed
NOTES mediastinal explorations in seven pigs [55]. In three
cases the animals were give pre - and postoperative doses
of intravenous prophylactic antibiotics. In the fi nal four
animals, no prophylaxis was administered. Esophageal
defects were closed with endoclips (3) or a proprietary T -bar
system (4). Survival times varied from two to six weeks. On
necropsy, no abscesses were noted on macro - or microscopic
analysis notwithstanding the different closure techniques
and survival periods. The next question that this group
addressed was the applicability of this model to a patient
who was not medically optimized. Using the experience
gained in their initial investigation, they completed a survival study in a cohort of 24 pigs [56]. Twelve animals were
taken from a healthy strain of pigs. The other twelve were
an experimental, compromised strain mimicking a physically unwell individual. The goal of the study was to compare
an endoscopic closure of a full thickness esophageal wall
injury to the gold standard thoracoscopic repair. Endoscopic
repairs were completed using the proprietary T -bar closure
system (TAS; Ethicon Endosurgery, Cincinnati, Ohio, USA).
In each case the animals received one day of prophylactic
intravenous antibiotics. Following a three -month survival
period, the animals were sacrifi ced and necropsies performed. All twelve of the healthy controls survived to the
end of the study. No evidence of infection or contamination
was noted at necropsy. In the compromised arm of the study,
one animal from the thoracoscopic and one from the endoscopic closure died early due to mediastinal contamination
and subsequent mediastinitis. Of the rest of the endoscopically closed animals, one animal had a mediastinal abscess
that was attributed to intra -procedure gastroesophageal
refl ux.
Human data
As with the available information for transcolonic natural
orifi ce experiments, the morbidity of an uncontrolled
esophageal perforation is signifi cant enough to be prohibitive of any studies in a human model at this time.
Summary
Much like the literature available for the transcolonic
approach to a natural orifi ce procedure, the preponderance
of reports of a mediastinoscopy or thoracoscopy completed
translumenally are completed in animal models. Moreover,
given the narrow spectrum of pathology necessitating treatment in the chest, less attention has been given to this
approach. However, what research has been completed is
promising. The structures of the mediastinum and thoracic
cavity can all be accessed from an endoscopic transesophageal approach. Furthermore, little data exists to suggest
that the infectious implications of this technique are probative to further exploration. Specifi cally, the work of Fritscher Ravens et al. has shown that a NOTES procedure can be
completed with a reasonable safety profi le even in the face
of cardiorespiratory compromise and gastroesophageal
refl ux disease.
Review
The fi eld of natural orifi ce surgery is still in its infancy. A
facile platform from which all quadrants of the abdomen can
be accessed has yet to be developed. Push -back from mainstream surgery for this approach mirrors the initial resistance to laparoscopy witnessed in the late 1980s and early
1990s. What is more, even in the cases when a procedure
has been proven to be safe, reimbursement remains a daunting proposition. With that said, there does not appear to be
any convincing evidence that the infectious implications of
this approach should deter further investigation in the fi eld.
Elegant studies from the transvaginal and transgastric
approaches have shown that the physiologic insult from a
natural orifi ce procedure is equivalent to laparoscopy. The
work by Hazey et al. has shown that the risk of contaminating the abdomen in a human is clinically insignifi cant. Initial
reports of transcolonic, transurethral, and thoracic techniques completed in animal models appear to be safe as well.
Whether or not, NOTES becomes the accepted approach to
abdominal or thoracic pathology in the future is yet to be
seen. However, the risk of infection related to NOTES should
play no role in the progression and maturation of the fi eld.
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23 Ramos AC, Murakami A, Galvão Neto M, et al. NOTES trans-
vaginal video -assisted cholecystectomy: fi rst series . Endoscopy
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24 Kalloo AN, Singh VK, Jagannath SB, et al. Flexible transgastric
peritoneoscopy: a novel approach to diagnostic and therapeutic
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25 McGee MF , Schomisch SJ, Marks JM, et al. Late phase TNF -
alpha depression in natural orifi ce translumenal endoscopic
surgery (NOTES) peritoneoscopy . Surgery 2008;143(3):318–28.
26 Eickhoff A, Vetter S, von Renteln D, et al. Effectivity of current
sterility methods for transgastric NOTES procedures: results of a
randomized porcine study . Endoscopy 2010;42(9):748–52.
27 Giday SA, Dray X, Magno P, et al. Infection during natural orifi ce
transluminal endoscopic surgery: a randomized, controlled
study in a live porcine model . Gastrointest Endosc 2010;71(4):
812–16.
28 McGee MF , Marks JM, Onders RP , et al. Infectious implications
in the porcine model of natural orifi ce transluminal endoscopic
surgery (NOTES) with PEG -tube closure: a quantitative bacteriologic study . Gastrointest Endosc 2008;68(2):310–18.
29 Ramamoorthy SL, Lee JK, Mintz Y, et al. The impact of proton -
pump inhibitors on intraperitoneal sepsis: a word of caution for
transgastric NOTES procedures . Surg Endosc 2010;24(1):16–20.
30 Narula VK, Hazey JW , Renton DB, et al. Transgastric instrumen-
tation and bacterial contamination of the peritoneal cavity . Surg
Endosc 2008;22(3):605–11.
31 Nau P, Anderson J, Yuh B, et al. Diagnostic transgastric endo-
scopic peritoneoscopy: extension of the initial human trial for
staging of pancreatic head masses . Surg Endosc 2010;24(6):
1440–46.
32 Memark VC, Anderson JB, Nau PN, et al. Transgastric endo-
scopic peritoneoscopy does not lead to increased risk of infectious complications . Surg Endosc 2011;25(7):2186–91.
33 Bretagnol F, Merrie A, George B, Warren BF , Mortensen NJ.
Local excision of rectal tumours by transanal endoscopic microsurgery . Br J Surg 2007;94(5):627–33.
34 Cheung HY , Leung AL, Chung CC, Ng DC, Li MK. Endo-
laparoscopic colectomy without mini -laparotomy for left -sided
colonic tumors . World J Surg 2009;33(6):1287–91.
35 Ooi BS, Quah HM, Fu CW ,EuKW . Laparoscopic high anterior
resection with natural orifi ce specimen extraction (NOSE) for
early rectal cancer . Tech Coloproctol 2009;13(1):61–4.
36 Mathews JC, Chin MS, Fernandez-Esparrach G, et al. Early
healing of transcolonic and transgastric natural orifi ce transluminal endoscopic surgery access sites . J Am Coll Surg
2010;210(4):480–90.
37 Raju GS, Pham B, Xiao SY , Brining D, Ahmed I. A pilot study
of endoscopic closure of colonic perforations with endoclips in
a swine model . Gastrointest Endosc 2005;62(5):791–5.
38 Bazzi WM, Wagner O, Stroup SP , et al. Transrectal hybrid natural
orifi ce transluminal endoscopic surgery (NOTES) nephrectomy
in a porcine model . Urology 2011;77(3):518–23.
39 Ramamoorthy SL, Fischer LJ, Jacobsen G, et al. Transrectal
endoscopic retrorectal access (TERA): a novel NOTES approach
to the peritoneal cavity . J Laparoendosc Adv Surg Tech A 2009;19(5):
603–6.
40 Voermans RP , van Berge Henegouwen MI, Bemelman WA ,
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e61–7.
41 Voermans RP , Faigel DO, van Berge Henegouwen MI, Sheppard
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42 Meining A, Wilhelm D, Burian M, et al. Development, stand-
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transsigmoid approach in the porcine model: an acute feasibility
study . Endoscopy 2007;39(10):860–64.
43 Dubcenco E, Grantcharov T, Eng FC, et al. “No scar ” small bowel
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25(3):930–34.
44 Pai RD, Fong DG, Bundga ME, et al. Transcolonic endoscopic
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45 Fong DG, Pai RD, Thompson CC. Transcolonic endoscopic
abdominal exploration: a NOTES survival study in a porcine
model. Gastrointest Endosc 2007;65(2):312–18.
46 Leroy J, Cahill RA, Perretta S, et al. Natural orifi ce translumenal
endoscopic surgery (NOTES) applied totally to sigmoidectomy:
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47 Wilhelm D, Meining A, von Delius S, et al. An innovative, safe
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48 Granberg CF , Frank I, Gettman MT . Transvesical NOTES: current
experience and potential implications for urologic applications .
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49 Karmouni T, Bensalah K, Alva A, et al. Role of antibiotic prophy-
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50 Cam K, Kayikci A, Erol A. Prospective evaluation of the effi cacy
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51 Detterbeck FC, Jantz MA, Wallace M, et al. Invasive mediastinal
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52 Sumiyama K, Gostout CJ, Rajan E, Bakken TA , Knipschield MA.
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53 Turner BG, Kim MC, Gee DW , et al. A prospective, randomized
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54 Gee DW , Willingham FF , Lauwers GY , Brugge WR, Rattner DW .
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55 Fritscher -Ravens A, Patel K, Ghanbari A, et al. Natural orifi ce
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56 Fritscher -Ravens A, Cuming T, Eisenberger CF , et al. Rand-
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38
5
https://t.me/med1917
NOTES Access Techniques
Eduardo A. Bonin & Christopher J. Gostout
Mayo Clinic, Rochester, MN, USA
Introduction
The three cases in this paper are reported in order to show that
the pleural cavity of one side may be freely opened with impunity under the ordinary arrangements of general anesthesia . . . This is not a new observation; I learned the lesson in
the war whilst removing shrapnel and bullets from the lung.
Flint ER, The surgery of access to the
pleural cavity, Br Med J , 1929
Natural orifi ce translumenal endoscopic surgery (NOTES) is
a surgical technique defi ned by its type of access. Instead of
utilizing the usual parietal wall and skin surface incision,
NOTES uses the visceral wall for access to the abdominal
and thoracic cavity. NOTES enables access not only to body
cavities but also to anatomical fascial planes, as in the case
of the transoral sublingual approach for applications in
thyroid and neck surgery [1].
A main theoretical advantage to NOTES is less intraoperative and postoperative pain due to preservation of parietal
somatic nerves that are injured from a body wall incision
during laparoscopic or open surgery. Adding the fact that
NOTES may require less abdominal insuffl ation [2], with
implications for anesthesia and use of postoperative analgesia, NOTES may be used outside of the traditional operating
room setting. For example, a bedside NOTES procedure may
be useful for the high -risk surgical patient in the ICU unable
to undergo general anesthesia. By avoiding skin incisions,
NOTES has an obvious and appealing cosmetic advantage
over any other surgical technique. This is especially benefi cial for patients with compromised wound healing, such as
post-burn skin scar and tendency to hypertrophic or keloid
scar formation. Avoidance of a visible scar is psychologically
benefi cial to children and advantageous to patients highly
concerned with their body image (models, actors). However,
the absence of an abdominal wall incision does not completely avoid the postoperative infl ammatory healing process
created after a surgical procedure on an internal organ.
Therefore, NOTES can be considered a minimal -access
surgery, which is not necessary synonymous with minimally
invasive “scarless” surgery, since postoperative discomfort
and internal adhesions (scars not visible externally) may
develop.
Surgical procedures using natural orifi ces as access have
been described since the 1940s by gynecologists as culdoscopy, a transvaginal endoscopic procedure currently used
mainly for evaluation of infertility. In laparoscopic general
surgery, the natural orifi ce route was initially used for
removing larger specimens in order to avoid larger abdominal incisions [3,4], a procedure recently termed natural
orifi ce specimen extraction (NOSE) [5]. The concept of a
translumenal approach emerged with enthusiasm during
the period 2004 –2005 due to a successful human case of
transgastric appendectomy (Table 5.1) [6]. For its complexity
and singularity the translumenal approach was categorized
not only as novel access, but also a novel minimally invasive
technique, ushering in the NOTES era.
After almost 6 years of investment and effort, NOTES has
become technically feasible in humans, often requiring Institutional Board Review (IRB) approval [7]. Recent series
have shown the feasibility of performing safe transvaginal
cholecystectomies and NOTES -assisted urologic, colorectal,
and bariatric procedures with at least 2000 human NOTES
procedures being performed worldwide [8,9]. Currently,
transvaginal access is the most common NOTES access in
humans (Figure 5.1).
There are current limitations for performing complex surgical tasks such as peritoneal navigation, dissection, tissue
approximation (suturing, stapling), and hemostasis. Prevention of infection and secure closure of the entry or access
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.
39
SECTION 1 Development of the NOTES Concept
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Table 5.1 Human NOTES access milestones.
Route Procedure Date
Oral Transgastric retroperitoneoscopic access for necrotizing pancreatitis 1998
Transgastric peritoneoscopic procedure: appendectomy 2004
Transesophageal myotomy 2008
Transoral thyroidectomy 2009
Vaginal Transvaginal peritoneoscopy using fl exible instruments 1999
Transvaginally assisted laparoscopic cholecystectomy (vaginal port used for insuffl ation, visualization. and specimen extraction) 2003
Transvaginal hybrid NOTES cholecystectomy (endoscope and operating instruments inserted in the vagina) 2007
Transvaginal “pure ” NOTES cholecystectomy (no retractors inserted in the abdomen) 2009
Anal Transrectal specimen extraction 1994
Transrectal fl exible peritoneoscopy for abscess drainage 2008
Transrectally assisted laparoscopic pull -through sigmoidectomy (one instrument inserted in the rectum) 2009
Laparoscopically assisted transrectal total mesorectal excision (endoscope and operating instruments inserted in the rectum) 2009
Urethral Flexible transvesical peritoneoscopy (case report of one patient) 2007
35
Anal route
30
(excluding
specimen
25
extraction)
20
15
10
Number of publications
5
0
2007 2008 2009 2010 2011
Year of publications
point remain important issues to be addressed. Moreover,
randomized trials comparing NOTES to a gold standard procedure (e.g., laparoscopy) are needed to confi rm its advantages and become a standard -of-care option. The aim of this
chapter is to address current techniques for NOTES access.
This will include its indications, technical aspects, advantages, and limitations.
Technical considerations for NOTES access
NOTES access can be divided into three components: (a) the
natural orifi ce (NO) route, (b) viscerotomy, and (c) the intracavitary route (Figure 5.2).
Oral route
Figure 5.1 Publications on human NOTES
Vaginal route
cases in the past 5 years (excluding
transgastric pancreatic necrosectomy
procedures). There was a total of 119
publications, including abstracts from
American and European national congresses
and meetings: Digestive Disease Week
(DDW), Society of American Gastrointestinal
Endoscopic Surgeons (SAGES), European
Association for Endoscopic Surgery (EAES).
The NO route and viscerotomy comprise the endolumenal
part of the procedure. The main four NO routes (oral,
vaginal, anal, and urethral) have access methods that can be
used as single or combined either in the abdomen or thorax
(Table 5.2).
Natural orifi ce access planning
Access planning is critical for a successful NOTES procedure.
The access site will infl uence the feasibility, ergonomics, and
safety of the operation (Table 5.3). It directly infl uences the
endoscope’s navigation, spatial orientation, and instrumentation. Current NOTES pre -operative planning should aim
for maintaining as straight an insertion tube position as possible [10]. The retrofl exed (hook) position impedes complex
40
CHAPTER 5 NOTES Access Techniques
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C
Figure 5.2 NOTES access components. The
illustration represents a fl exible endoscope
being inserted orally and reaching the
abdominal cavity across the stomach. A)
natural orifi ce (NO) route, B) viscerotomy, and
C) intracavitary route.
Table 5.2 Natural orifi ce translumenal endoscopic surgery access
routes and types of access.
Route Type of access
Oral, upper GI tract Transoral (sublingual), transesophageal,
transgastric (gastric body, antrum),
transduodenal (duodenal bulb)
Anal (transanal), lower
GI tract
Urethral (transurethral),
urinary tract
Vaginal (transvaginal) Cul-de-sac
Umbilical (transumbilical),
umbilical scar
a
Transumbilical access is a natural scar access.
a
Transrectal, transcolonic (sigmoid, also
referred as transsigmoid)
Transvesical
Transumbilical skin and fascia
B
A
Table 5.3 Technical considerations for NOTES access.
1 NOTES access availability (evaluation for natural orifi ce route
patency, e.g., esophageal stenosis, disrupted anatomy and
adhesions, e.g., hysterectomy)
2 Type of anesthesia and patient positioning
3 Risk of contamination: endolumenal presence of cancer cells and
also quantity and quality of microorganisms
4 Access planning
i Anatomic and ergonomic aspects of patient ’s natural orifi ce and
intracavitary routes
ii Use of combined laparoscopic/endoluminal/NOTES access and
instruments
5 Point of entry access technique
i Preinsuffl ation of the abdominal cavity
ii Use of imaging for guidance (peritoneoscopy or ultrasound)
iii Creation of viscerotomy (open dissection or puncture)
iv Maintaining access and providing protection from contamination
of the peritoneal cavity
6 Specimen removal
7 Safe access closure/sealing
surgical tasks, producing signifi cant image rotation (Figure
5.3) and, more so, constraints to instrument handling, and
perhaps most importantly, impeded target site access. For
example, transvaginal (direct) access to the gallbladder is
superior to the transgastric retrofl exed approach in human
cadaver specimens [11]. Indeed, according to our own experience, transgastric access to the liver and upper abdomen is
usually carried out with signifi cant endoscope retrofl exion
[12]. It may be overcome by the use of a double -bending
endoscope or the use of gastric submucosal tunneling prior
to exiting into the abdomen to fi x the direction of the insertion tube [13].
Another access planning approach involves combined
access employing two different NO routes (Figure 5.4),
which may facilitate endoscope and instrument triangulation or organ retraction [14–17]. An example of this approach
is a combined transgastric and transanal sigmoid resection
[16]. In this experimental technique a round -tip endolumenal manipulator is inserted per anum to facilitate colon
exposure and dissection. The mesentery is dissected with
instruments through the channels of the transgastric endoscope. Specimen removal and colorectal anastomosis is performed transanally. Another access option for also achieving
the so -called “pure” NOTES procedure is inserting two endoscopes into the same NO orifi ce. This technique has already
been described in humans for transvaginal cholecystectomy
and uses one of the endoscopes solely for gallbladder retraction [18].
For improving NOTES access, novel endoscopes and operating platforms may be needed to overcome orientation and
navigation issues. Currently none is clearly superior to
others [19].
Spillage control to avoid peritoneal contamination
By defi nition, a NOTES procedure requires deliberate
visceral perforation for gaining access, which would not
41
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