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SECTION 1 Development of the NOTES Concept
https://t.me/med1917
Peritoneum
Like laparoscopic surgery, NOTES procedures require pneumoperitoneum to lift the abdominal wall and visualize the
abdominal cavity. Known deleterious effects of high intra abdominal pressures include reduced cardiac output,
decreased airway compliance, increased airway pressure,
and acute renal failure. Studies attempt to elucidate which
insuffl ation pressure is robust enough to allow for visualization of the abdominal cavity without impinging on cardiovascular and respiratory status.
Pressure readings obtained through the instrumentation
channel of the endoscope correlated with true measured
intra-abdominal pressures in a study performed by McGee
and colleagues [19]. Pressures measured directly in the peritoneum, tubing at the shaft of the endoscope, insuffl ator
output, and biopsy port of the endoscope were all equivalent. These fi ndings were reproduced when pressures measured by von Delius and colleagues through the endoscope
and those measured via Veress needle in carbon dioxide and
air insuffl ation NOTES study groups were compared [14]. A
statistically signifi cant difference in intra -abdominal organ
identifi cation was seen between the carbon dioxide and air
insuffl ation NOTES groups. The NOTES room air study arm
missed 28% of the target organs, while 13% of the target
organs were not identifi ed in the NOTES carbon dioxide
study arm. Blinded videotape analysis between both NOTES
groups illustrated no difference in overview of the peritoneal
cavity, bowel distention, and gut motility.
Comparatively, pressure -controlled insuffl ation during
more complex NOTES procedures appears to be imperative
in preventing intra -abdominal hypertension [17]. Swine
were subjected to initial intra -abdominal pressure measurement and controlled insuffl ation of 12 mmHg with feedback.
In the uncontrolled intra -abdominal pressure group, 31%
and 17% of operative time was spent at intra -abdominal
pressures greater than 15 mmHg and 20 mmHg, respectively.
In the controlled insuffl ation group with feedback, intra abdominal pressure was 1% and 0.2% of operative time was
spent at the higher pressures. No difference was noted in
visualization between the two groups. However, the endoscopist did not notice clinical signs of elevated intra abdominal pressure in 54% of pressures greater than
15 mmHg. This data strongly supports the use of controlled
insuffl ation to maintain safe intra -abdominal pressures
during complex NOTES procedures.
Endoscopic peritoneal access and insuffl ation in human
subjects appears to be safe even in the setting of previous
abdominal surgery [20]. Nau et al. enrolled 20 patients
slated to undergo laparoscopic Roux -en-Y gastric bypass
surgery and subjected each to diagnostic transgastric endoscopic peritoneoscopy before their scheduled procedure. Ten
patients had a virgin abdomen while ten had a history of
previous abdominal surgery. Pneumoperitoneum was
created with a pressure of 10 mmHg and verifi ed with a
Veress needle in the left upper quadrant. Upon completion
of diagnostic peritoneoscopy, the endoscope was removed
and the gastrotomy was used for placement of an anvil for
gastrojejunostomy creation. The gastrotomy was closed at
the end of the procedure [20].
Data was collected regarding length of time to establish
transgastric access; time required to complete diagnostic
peritoneoscopy; intra -abdominal pressure obtained with
endoscope and Veress needle; adequacy of exploration and
visualization; presence of adhesions; and necessity of adhesiolysis. Any intra - or postoperative complications were also
noted.
All 20 patients safely completed the transgastric endoscopic peritoneoscopy and subsequent gastric bypass procedure. The average time to transgastric access was 9.6 minutes.
On average, 16.1 minutes were required to complete the
peritoneoscopy. Mean peritoneal pressures measured by the
endoscopic insuffl ator measured 9.8 mmHg. This was verifi ed with mean peritoneal pressures of 9.8 mmHg as measured with Veress needle. Visualization during endoscopic
transgastric peritoneoscopy was noted to be rated 5 out of 5
in all four quadrants of the abdomen. Adhesions were noted
in 40% of the participants; however, adhesiolysis was completed endoscopically in only one patient. No major intra - or
postoperative complications arose related to peritoneoscopy.
Four patients were noted to have small cautery burns on the
anterior abdominal wall and nine patients suffered minor
cautery burns to the dorsal left lobe of the liver.
This study illustrated transgastric access and subsequent
endoscopic abdominal exploration is feasible, even in
patients with a history of abdominal surgery. This study also
addresses the ability to create pneumoperitoneum via endoscopic insuffl ation rather than using the Veress needle. The
authors utilized carbon dioxide to insuffl ate the abdomen in
this study with no untoward complications noted [20].
Another proposed benefi t of NOTES is decreased postoperative adhesion formation as NOTES procedures avoid
peritoneal disruption. An estimated 400 000 adhesiolysis
operations are performed annually in the United States and
are estimated to cost the healthcare system $2 billion. Additionally, once adhesions form, patients have an increased
lifetime risk of small bowel obstruction, chronic abdominal
pain, and re -operation [21].
A study was conducted by Dubcenco and colleagues to
compare the rate of adhesion formation in pig models after
20-minute peritoneoscopy with liver biopsy by laparotomy,
laparoscopy, and transgastric NOTES. Peritoneal pressures
were constant at 10 mmHg for laparoscopic and NOTES procedures. Necropsy was performed on all pigs 14 days postprocedure evaluating adhesion formation, peritonitis, and
abscess formation. The Hopkins Adhesion Formation Score
was designed and used to grade extent of adhesions in each
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CHAPTER 3 Physiology of NOTES
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Table 3.1 Macroscopic and histologic comparison of common gastrotomy closure techniques: endoscopically placed clips, push threaded tags
(T -tags), and pull T -tags [24].
Closure type Gastrotomy closure Mucosal bridging Muscular bridging Infl ammation Transmural healing
Clip 100% 75% 100% 75% 75%
T-tag, push technique 100% 25% 0% 0% 0%
T-tag, pull technique 100% 25% 25% 25% 25%
animal by two independent investigators. The score evaluated frequency of adhesion formation, size, organs involved,
Gastrointestinal tract
dissectability, vascularization, and density of the adhesions.
Adhesion bands were also sent for histopathological evaluation [21].
At necropsy, none of the animals in any study group had
evidence of peritonitis or abscess. Grossly, 16.7% of pigs in
the NOTES group had adhesion formation, 100% of the pigs
in the laparotomy group had adhesions, and 33.3% of the
pigs in the laparoscopy study group had adhesions. These
results were statistically signifi cant between the laparotomy
and NOTES group and the laparotomy and laparoscopy
group. No statistically signifi cant difference was noted
between the laparoscopy and NOTES groups. Additionally,
laparotomy and laparoscopy were associated with both visceral and parietal adhesions while NOTES was associated
with visceral adhesions only. Microscopically, the adhesions
consisted of collagen, fi brin, neovascularization, and proliferation of fi broblasts [21].
Similarly, no statistically signifi cant difference was noted
in the amount or size of the adhesions in a porcine model
comparing NOTES transgastric endoscopic and traditional
laparoscopic colotomy repair [22].
Extent of injury to the peritoneum may play a role in
adhesion formation and abdominal wall incision is the most
common nidus for adhesion formation. Damage to the peritoneum leads to release of growth factors and cytokines that
lead to synthesis of the factors thrombin and fi brinogen,
which crosslink to form a network [21].
Utilizing a porcine model comparing diagnostic laparoscopy, diagnostic NOTES peritoneoscopy, NOTES transgastric
mesh placement, and diagnostic endoscopy with laparoscopy; specimens from liver, lung, and spleen were investigated. On histologic examination, the incidence of liver
fi brosis and spleen capsulitis was not statistically signifi cant
among the treatment groups; however, the NOTES mesh
group had signifi cantly increased liver fi brosis mean severity
scores. The infl ammatory reaction was higher still in those
animals in the NOTES mesh group with mesh infection.
Thus, the transgastric access of NOTES procedures is not
necessarily less invasive than traditional laparoscopy [23].
Multiple methods exist for closing access sites from NOTES
procedures. Common closure techniques include endoscopically placed clips, push threaded tags (T -tags), and pull
T-tags. A macroscopic and histologic comparison of each
technique can be found in Table 3.1 [24]. Gastrotomy site
healing after transgastric NOTES procedures has been
observed to be superior with endoscopic clips in animal
studies. Endoscopic clips approximate only the superfi cial
layers of the gastric wall, which allows opposition of mucosa
from both sides of the gastrotomy (Figure 3.1a). Histological
analysis of clip closure illustrated complete closure, mucosal
bridging, muscular bridging, infl ammation, and transmural
healing of the gastrotomy 14 days after NOTES procedure
(Figure 3.1b). The T -tag closure technique inverts the gastrotomy edges. Histologic analysis with T -tag closure illustrated transmural healing in only 12.5% of animals, and
gastric wall muscular bridging was recorded in only 12.5%
of animals [24].
In addition to the mechanism of closure, the intragastric
pressure may also factor into the strength or failure of gastrostomy closure. Desilets and colleagues devised a study to
examine the effect, if any, of intragastric pressure on the
integrity of gastrostomy closure [25].
Eleven pigs were anesthetized but not paralyzed. A Veress
needle was inserted into the abdomen and a gastroscope was
placed into the stomach. Pressure measurements were
recorded simultaneously in the abdominal compartment
and stomach lumen. From these measurements, a gastric
transmural pressure gradient was calculated. Measurements
were taken under 12 mmHg of pneumoperitoneum; with
the stomach empty, infl ated, or fi lled with 1 liter of saline
solution; and during respiration, stimulated cough, and
stimulated Valsalva.
The experiment illustrated that respiratory variation in
intra-abdominal and gastric pressures mirrored each other,
and the difference between the two remained near zero
throughout the respiratory cycle. The gastric transmural
pressure was near zero for all experimental conditions
23
SECTION 1 Development of the NOTES Concept
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and no statistically signifi cant pressure differences were
noted.
The stomach is highly compliant and increases in volume
at constant pressure. Intragastric pressure will not increase
until the stomach has reached maximum capacity and
the muscular wall of the stomach cannot relax. Of note, the
abdominal cavity is a closed space, and as the volume of the
(a)
(b)
Figure 3.1 Wound healing of NOTES gastrotomy, 14 -days
postoperatively. (a) Mucosal surface; (b) serosal surface.
stomach increases, the intra -abdominal volume decreases.
The abdomen also increases its pressure as the pressure in
the stomach increases to prevent further expansion of the
stomach. Their study confi rms this as the net pressure gradient was near zero under all experimental conditions.
With gastric transmural pressure gradient proposed to be
zero or very close to zero, it can then be concluded that
gastric pressure should not have much impact on the success
of gastrostomy closure [25].
Immunology
A signifi cant function of the abdominal wall is as an early
warning system for intrusion from the outside into the vital
intrathoracic and intraperitoneal organ spaces. Each skin
incision therefore causes an immunologic reaction with systemic consequences. Studies comparing open and laparoscopic surgery have used serum and peritoneal cytokine
levels and serum cortisol as proxies for the systemic infl ammatory response. If we can avoid abdominal wall incisions,
can we then not avoid a large portion of the infl ammatory
response? The NOTES approach often utilizes incisions into
the GI tract. The GI tract itself, however, is the seat of
approximately one -third of the body ’s entire immune system
(Figure 3.2). Several experimental randomized studies have
investigated the immunologic impact of NOTES in comparison with laparoscopy. These experimental studies, however,
suffer from limitations in the tools used to measure the
differences.
In experimental swine models, the determination of
serum cytokines is technically diffi cult. Only one manufacturer currently produces an assay available for purchase for
a number of cytokines in the porcine model. Unfortunately,
the results are unstable at lower serum levels. This may have
contributed to a large number of cytokines not being determined in the laboratory in the different studies [12,19]. The
sheer technical diffi culty with the low -level cytokine
response is also refl ected in the inconsistent results in com-
Figure 3.2 Sites of immunologic reaction relative to incision site in abdominal surgery.
24
Intestine is the seat of 1/3 of the immune system,
more difficult to access for studies than serum
and not well investigated
Abdominal wall,
traditional site of entry,
every incision
generates an immune
reaction
Peritoneal cavity, large immunologically active space, local reaction significant
but not necessarily represented in serum levels of inflammatory markers
CHAPTER 3 Physiology of NOTES
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Table 3.2 Pooled comparison of peritoneal IL-6 levels at various time
points after open, laparoscopic, NOTES, and sham operations
[12,26–28].
Time postoperatively Laparoscopic NOTES Open Sham
2 hours ↑
4 hours ↑
6 hours ↑↑↑
24 hours
48 hours ↑
7 days ↑↑
↑=statistically signifi cantly increased.
Table 3.3 Pooled comparison of peritoneal TNF-α levels at various
time points after open, laparoscopic, NOTES, and sham operations
[12,26–28].
Time postoperatively Laparoscopic NOTES Open Sham
levels for all groups. This rise was statistically signifi cantly
different between open, control, and NOTES groups. On
postprocedure day seven, TNF -α serum levels from NOTES
animals were statistically signifi cantly lower than from
laparoscopic and control animals. This was also observed on
Immediate ↑↑↑↑
1 hour
24 hours ↑↓↓↓
48 hours ↑↑↓↑
7 days ↓↓↑
14 days ↓↑
↑=statistically signifi cantly increased; ↓=statistically signifi cantly
decreased; ↑↓ = unchanged.
postprocedure day 14. No statistically signifi cant differences
were noted between IL -1β and IL -6 levels throughout the
study. The profound and preserved decrease in proinfl ammatory TNF -α in the late postprocedure period was demonstrated in the NOTES animals only [28].
erative immunoparalysis, either benefi cial or detrimental. A
proposed benefi t would be to counteract immediate postoperative hyperinfl ammation, which would therefore decrease
proinfl ammatory mediators and, subsequently, acute respiratory distress syndrome, systemic infl ammatory response
syndrome, and multisystem organ failure. Conversely, cliniparisons of open and laparoscopic surgery and the recent
interim results of a single -port versus laparoscopic cholecys-
cal reports have correlated postoperative immunoparalysis
with increased infections and bacterial growth [28].
tectomy trial [10]. Peritoneal cytokines show a larger
response and are more easily detected [26]. We will describe
a number of the studies and their discordant results below.
A summary of several studies is shown in Tables 3.2, 3.3,
and 3.4 [12,26–28].
One study measured serum interleukin (IL) levels after
laparoscopic and NOTES procedures to further elucidate if
NOTES is less invasive than traditional laparoscopy. The
study illustrated similar serum TNF -α levels at the beginning
and end of laparoscopic and NOTES procedures. TNF -α
TNF-α suppression may be due to intraperitoneal bacterial
priming. The gastrotomy may be the initial trigger for the
infl ammatory response, while subsequent bacterial contamination of the peritoneal cavity may lower systemic activity
of proinfl ammatory cytokines [28]. However, other studies
have recorded an increase in TNF -α and this study also suffered from incomplete specimen analysis due to assay limitations. It is therefore possible that the results are due to
experimental bias rather than true differences.
levels were noted to rise on postoperative day one in the
NOTES group and decreased in the laparoscopic group [12].
Another study compared serum TNF -α, IL -1β, and IL -6
levels after exploratory laparoscopy, exploratory transgastric
NOTES peritoneoscopy, exploratory laparotomy, and sham
procedures in a swine model. The study revealed a statistically signifi cant decrease of serum interleukins after NOTES
procedures [28].
matory response after laparoscopic and natural orifi ce trans-
lumenal cholecystectomy. This study compared circulating
TNF-α and IL -6 levels preoperatively, 24 -hours postopera-
tively, and 48 -hours postoperatively in pigs undergoing
NOTES transvaginal cholecystectomy, laparoscopic chole-
cystectomy, and control general anesthesia. Results were
notable for statistically signifi cantly increased TNF -α levels
Table 3.4 Pooled comparison of peritoneal IL -1β levels at various
time points after open, laparoscopic, NOTES, and sham operations
[12,26–28].
Time postoperatively Laparoscopic NOTES Open SHAM
4 hours ↑
6 hours ↑↑
24 hours ↑↑↑
7 days ↑
↑=statistically signifi cantly increased.
A rise was seen in postprocedure and one -hour TNF -α
The authors comment that there may be a role of postop-
McGee and colleagues speculate perhaps the late phase
A third experimental study examined the systemic infl am-
25
SECTION 1 Development of the NOTES Concept
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on postoperative day one in laparoscopic animals compared
to control and NOTES groups. The authors did not fi nd a
signifi cant difference to NOTES approach. However, only
two animals in the laparoscopic and four animals in the
NOTES group were included, which makes it diffi cult to
draw any clinically meaningful conclusions [27].
In a different study, serum cortisol peak levels were not
signifi cantly different among NOTES and laparoscopy
groups; however, the serum cortisol levels rose faster in the
NOTES groups compared to the laparoscopy groups. Overall
peak responses were not statistically different among study
groups, and peak levels occurred between four to six hours
postoperatively [26].
The infl ammatory responses can also be measured using
intraperitoneal interleukins [26]. Postoperative measurements of peritoneal TNF -α, IL -6, IL -1β, and serum cortisol
in open, laparoscopic, and NOTES procedures at different
time points illustrated a statistically signifi cant increase of
TNF-α at four hours and IL -6 at six hours between laparoscopy with carbon dioxide insuffl ation and laparoscopy with
air insuffl ation. At these times points, the NOTES procedure
groups illustrated no statistically signifi cant difference compared to laparoscopic procedures. In the acute postoperative
phase, carbon dioxide groups illustrated higher peritoneal
TNF-α levels on postoperative day one and maintained
higher IL -6 levels on postoperative day two. These results
further support no statistically signifi cant increase of physiologic stress on the body [26].
Infection
Considerable concern has been voiced relative to the infectious complications of NOTES procedures. A number of
experimental studies revealed the impact of peri -operative
antibiotic, gastric lavage, and acid suppression prior to transgastric NOTES. Oral decontamination and gastric lavage of
about 500 cc saline in the porcine model reduced the gastric
contamination signifi cantly [29]. Increasing the irrigation
fl uid amount did not improve signifi cantly on that. Acid
suppression did not show a detrimental impact if irrigation
was used. In other studies, proton pump inhibitors did
increase the contamination [30].
A study examined contamination after colonic perforation
closure by laparoscopy or transgastric access. Diagnostic
peritoneal lavage (DPL), performed to investigate peritoneal
contamination, fl uid analysis was not statistically signifi cantly different between the NOTES and laparoscopic
animals.
At necropsy six animals in the laparoscopic arm and one
animal in the NOTES arm had signifi cant bacterial growth
at levels consistent with infection. In the NOTES group, no
statistically signifi cant difference was noted in infection rates
in animals that did and did not receive gastric lavage.
The frequency of wound infection is lower in sterile versus
non-sterile NOTES peritoneoscopy [31]. In the sterile arm
of the study, all endoscopes and accessories were disinfected
with Cidex solution and gas sterilized; oral cavities of animals
were disinfected with broad -spectrum, topical, iodophor
microbicide; intravenous antibiotics were administered to
the animals; operators were dressed in sterile gloves, gowns,
and facemasks; and the distal esophagus and stomach were
lavaged with povidone -iodine solution. In the non -sterile
arm of the study, animals underwent the same NOTES procedure with the use of clean, non -sterile instruments and
accessories without antibiotics, oral cavity sterilization, or
gastric lavage.
None of the animals in the sterile arm of the study
illustrated any signs or symptoms of infection in the
seven-day postoperative period. At necropsy, none of
the animals had gross evidence of infection, and 0% of the
animals had positive intraperitoneal cultures. Twenty -fi ve
percent of the animals in the non -sterile group exhibited
signs of intraperitoneal infection, fever, and poor appetite
within 48 -hours postoperatively, requiring treatment
with intravenous antibiotics. At necropsy, 100% of the
animals in the non -sterile group demonstrated gross evidence of intraperitoneal infection. Additionally, 100% of the
animals that underwent non -sterile NOTES procedures had
positive intraperitoneal culture results [31]. As multiple
factors were bundled in the sterile versus non -sterile arm
it is diffi cult to assess which of the factors is the main
confounder.
Eickhoff and colleagues yielded similar results [32]. Eight
control and eight therapy swine underwent NOTES exploration of the gallbladder and tubal ligation. The control animals
received gastric cleansing with sterile saline solution. The
therapy group received 40 mg esomeprazole IV 30 minutes
prior to intervention, oral lavage with 200 ml chlorhexidine,
gastric irrigation with 40 mg of neomycin diluted in 250 ml
sterile saline, 1.5 g cefuroxime IV, and 500 mg metronidazole
IV. Prior to closure of the gastrotomy in all animals, peritoneal biopsy was taken to evaluate for microscopic peritonitis.
Peritoneal smears and dilutions were collected from each
quadrant for culture. Postoperatively, one animal was euthanized on postoperative day three due to diffuse peritonitis
secondary to gallbladder perforation. The remaining 15
animals were included in analysis.
Positive microbial smears were signifi cantly increased in
specimens taken directly before gastrostomy closure in the
control animals. The corresponding bacterial load was also
statistically signifi cantly lower in the treatment animals.
Additionally, smears taken 14 days postprocedure were positive in both the control and treatment groups. The bacterial
load was again statistically signifi cantly higher in the control
animals. Two animals in the control group also clinically
exhibited signs of infection as noted by low food intake,
weight reduction, and inappropriate social behavior. A dif-
26
CHAPTER 3 Physiology of NOTES
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ference in organism colonization was not noted between the
control and therapy groups.
The study illustrated intravenous antibiotics, topical antimicrobial lavage of the mouth and stomach, and intravenous PPI therapy reduces the peritoneal bacterial load. This
was associated with lower peritoneal and systemic infection
rates [32]. Again, multiple confounders were examined
together and it is not clear from the results which factor is
most important.
The results of these studies support adherence to antiseptic conditions. It also suggests the importance of cleaning the
oral cavity specifi cally, as most of the peritoneal infections
were caused by oral fl ora [31]. One must also bear in mind
the risks of utilizing gastric lavage: aspiration, added procedure and anesthesia time, and increasing gastric pH and
decreasing bacteriostatic properties [22].
Many of these experimental results are superseded,
however, by the large clinical experience presented by the
Ohio group [33,34]. In more than 100 patients with transgastric access at the time of other planned surgical procedures, no clinically apparent infections have been reported.
This is also supported by the clinical experience in laparoscopic gastric bypass surgery, where frequently a gastrotomy
is open to the peritoneal cavity for some time and a Cidex
cleaned, but not sterilized, endoscope may be introduced
through the gastrotomy to aid with anastomosis. No increase
in infectious complications has been noted.
Conclusion
NOTES seeks to enter the peritoneal and chest cavity in a
less invasive manner than traditional laparoscopy. Review
of experimental and clinical studies illustrates no signifi cant
advantage or disadvantage of NOTES over laparoscopy in
regard to cardiovascular, pulmonary, and immunologic
systems; current literature demonstrates numerous studies
investigating similar physiologic parameters with confl icting
evidence. However, NOTES procedures appear to elicit less
pain than laparoscopic surgery. Further prospective randomized trials are necessary to further elucidate the role of
NOTES.
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27 Fan JK, Tong DK, Ho DW , et al. Systemic infl ammatory response
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28 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.
29 Buck L, Michalek J, Van Sickle K, Schwesinger W, Bingener J.
Can gastric irrigation prevent infection during NOTES mesh
placement? J Gastrointest Surg 2008;12(11):2010–14.
30 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.
31 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.
32 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.
33 Narula VK, Happel LC, Volt K, et al. Transgastric endoscopic
peritoneoscopy does not require decontamination of the stomach
in humans . Surg Endosc 2009;23(6):1331–6.
34 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.
28
4
https://t.me/med1917
Infection Control in NOTES
Peter N. Nau & Jeffrey W. Hazey
The Ohio State University Medical Center, Columbus, OH, USA
Introduction
Natural orifi ce translumenal endoscopic surgery (NOTES)
encompasses numerous potential approaches to accessing
the peritoneal cavity, mediastinum, or thoracic cavity.
The varied characteristics of each technique employed have
associated qualities that must be considered during
protocol development. The vagina is a validated method for
accessing the peritoneal cavity. Further, the colpotomy can
be reliably and safely closed. In accessing the peritoneal
cavity, the muscular wall of the stomach is uniquely suited
to withstand the shearing forces associated with an endoscopic procedure. The colon provides for varied vantage
points from which to work and can be incorporated into a
resection if needed. Unique properties with each technique
must be considered when choosing an access site to the
peritoneal cavity.
One of the purported benefi ts of a laparoscopic operation
is the decreased systemic trauma and time for convalescence. Many have suggested that these characteristics are
further associated with a decrease in the insult to the systemic immune system when compared to those from a
laparotomy [1]. Currently, there is a paucity of data related
to the control of infection and the systemic immune response
in the fi eld of natural orifi ce surgery. With NOTES, perhaps
the most important consideration is which approach to use
in accessing the abdominal cavity. Fundamental to this decision is the unique collection of bacterial fl ora, both in level
of contamination and species of each natural orifi ce,
and how this infl uences the risk to the patient. The following is a review of the infection control issues of a natural
orifi ce procedure based on the different routes available for
entering the abdominal cavity, mediastinum, and thoracic
cavity.
Transvaginal
The use of a colpotomy for the establishment of transvaginal
access to the abdominal cavity was introduced in 1813 with
Konrad Langenbeck ’s description of the transvaginal hysterectomy [2]. In 2003, Tsin et al. published a case report
describing culdoscopy and a culdolaparoscopic cholecystectomy in which the abdomen was explored and the gallbladder extracted transvaginally following a vaginal hysterectomy
[3]. Since that time, the indications for a colpotomy have
expanded outside the gynecologic literature. For instance, it
has been identifi ed as a means for specimen extraction in
minimally invasive gastric, urologic, and colorectal procedures [4–6].
More recently, animal and human protocols have utilized
the vagina as an access point for natural orifi ce procedures.
However, it is an approach that is not without inherent
limitations. It is only applicable to half of the population.
Available literature suggests that the majority of women are
reluctant to use this approach in a NOTES setting secondary
to concerns over dyspareunia and infertility [7,8]. With that
said, the transvaginal approach has been shown to be safe
and feasible, demanding further investigation as to its potential indications.
A prophylactic dose of intravenous antibiotics is an
effective means of decreasing the rate of pelvic infections
following vaginal hysterectomies [9,10]. Further, the risk
of infection associated with a vaginal procedure is as low
as 3.9% [11,12]. However, data is only now emerging
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.
29
SECTION 1 Development of the NOTES Concept
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concerning the physiologic and infectious implications of a
transvaginal natural orifi ce procedure.
Animal data
A recent investigation by Suzuki et al. addressed the physiologic and infectious stresses associated with a transvaginal
NOTES procedure [13]. In this experiment they used a
porcine model to compare a NOTES cholecystectomy to
standard laparoscopic cholecystectomies. To evaluate the
impact on the immune system, they recorded white blood
cell (WBC) counts and infl ammatory cytokines TNF -α, IL 1α, and IL -6. Samples were taken pre -operatively and then
again on postoperative days 1, 3, and 7. These parameters
refl ect the level of response by the immune system to the
operative-related trauma. High levels of the aforementioned
cytokines are associated with increased bacterial load, systemic infl ammatory response syndrome (SIRS), and multisystem organ failure. Cardiopulmonary data including heart
rate, mean blood pressure, oxygen saturation, and the
partial pressures of arterial CO
establish the physiologic impact of transvaginal NOTES. At
the completion of the study the animals were sacrifi ced
and necropsies performed. They noted that the WBC, IL -1α,
and IL -6 levels were similar between the laparoscopic and
NOTES groups. TNF -α levels were signifi cantly lower in the
NOTES group. Additional analysis of the cardiopulmonary
data showed no difference in the physiologic insult between
the two groups. A similar study completed by Fan et al.
measured IL -6 and TNF -α levels at 24 and 48 hours following transvaginal NOTES and laparoscopic cholecystectomies
in a porcine model [14]. They found no signifi cant difference
between the mean TNF -α and IL -6 levels at 48 hours postprocedure. While the sample sizes of these two studies were
small, in an animal model, transvaginal NOTES does not
expose the animal to an increased physiologic demand when
compared to classic laparoscopic techniques.
Having established the demand placed on the cardiac and
immune systems during NOTES, the next step is to identify
effects at a macroscopic level. In other words, what are the
infectious consequences of passing an endoscope into the
abdominal cavity through a nonsterile natural orifi ce?
Further, what level of decontamination of the endoscope
and vagina is necessary to maximize the safety of this technique? These questions were initially addressed in animal
models. In most cases a single pre -operative dose of prophylactic intravenous antibiotics was administered. This was
most often a fi rst -generation cephalosporin, occasionally in
combination with metronidazole. Additional preparation of
the vagina was completed with a povidone -iodine solution
in many protocols [13,15–17]. For the majority of studies,
necropsies identifi ed no evidence of infection or intra abdominal abscesses. However, it is diffi cult to make defi nitive conclusions based on these studies due to the variability
of techniques and reported fi ndings.
and O 2 was collected to
2
Two groups performed more rigorous evaluations of the
abdominal contamination of the peritoneal cavity following
transvaginal NOTES procedures in a porcine model [17,18].
In the study by Lomanto et al., peritoneal washes were
taken following entrance to the abdomen, at the end of the
operation, and at necropsy [17]. These samples were submitted for microbiologic assessment. In four of the fi ve
animals, the three specimens were successfully collected. In
the fi fth, the only sample recovered was collected at time of
colpotomy, resulting in a total of thirteen washes tested.
Microbiologic analysis showed low levels of contamination
in four of the thirteen specimens (31%). Most importantly,
no gross evidence of infection was noted in any animal.
In the experiment completed by Yang et al., eighteen
swine underwent transvaginal peritoneoscopy and laparoscopic cholecystectomies [18]. In all cases, the animals were
given pre -operative cefazolin that was continued for three
days postprocedure. The experimental arm of the study
underwent an iodine -enriched vaginal preparation followed
by a laparoscopic peritoneal irrigation with a solution of
cefazolin and metronidazole. The other nine animals had
vaginal preps and peritoneal irrigation performed with just
normal saline. In each case, cultures were taken from the
vagina and abdominal cavity prior to and after preparation
as well as from the peritoneum at necropsy. At necropsy,
positive cultures were noted in six of the nine (67%) animals
in the group with antibiotic -free preparations and in none
of those that were exposed to antibiotic -infused preparations. No animals in either group had peritoneal abscesses
identifi ed. Given this information, it is clear that despite the
propensity of contamination of the peritoneal cavity, the
amount is not signifi cant clinically, with no documentation
of infectious complications.
Human data
A review of the available animal literature suggests that a
transvaginal NOTES procedure has minimal infl ammatory
affects on the body as whole. Further, the infectious risk of
this approach is negligible outside of a microscopic assessment. However, the validity of translating this data from an
animal model to a human patient is conjecture. Currently,
there are multiple case series varying from one patient to
over one hundred of hybrid and totally NOTES procedures
completed transvaginally [19–22]. The majority of patients
are given a fi rst -generation intravenous cephalosporin,
often with a concomitant dose of metronidazole. In only one
study was the use of a prophylactic intravenous antibiotic
not described [23]. Further, most of the protocols involved
an iodopovidone cleansing of the vagina. Interestingly, none
of the reviewed literature described the method for cleaning
the endoscope. With that said, of the 335 cases reviewed,
there was only one infectious complication [19]. This was a
pouch of Douglas abscess that was treated with laparoscopic
drainage. Given this data, the clinical infectious risk of a
30
CHAPTER 4 Infection Control in NOTES
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transvaginal natural orifi ce procedure appears to be minimal
when using prophylactic intravenous antibiotics.
Summary
Limitations to the progression of transvaginal NOTES persist,
including lack of sophisticated working platforms and limited
patient interest. Moreover, there are inadequacies of the
available data. In the reviewed literature, there is a lack of
standardization in the protocols used for prepping the vagina
and IV antibiotic prophylaxis. Further, few of the available
studies identify the methodology used for decontamination
of the endoscope. A review published by Zorron et al. discussed 277 transvaginal appendectomies and cholecystectomies completed at sixteen centers in nine different countries
[19]. In this prospectively collected database of information,
there was a lack of consistency in the methodology used for
endoscope cleaning. They reported that endoscopes were
either sterilized with ethylene oxide or aggressively disinfected with glutaraldhyde 2% or peracetic acid 3% solution.
A standardized protocol that minimizes the infectious risk of
this technique must be identifi ed. The available data does
not identify infection as a potential constraint for transvaginal NOTES procedures. Based on this information, concerns
over the infectious implications of the transvaginal technique should not delay the progression of NOTES.
Transgastric
Flexible endoscopy with concomitant therapeutic and diagnostic procedures for pathology of the upper gastrointestinal
track is a well -established technique. It was with the application of this expertise that Kalloo introduced natural orifi ce
translumenal endoscopic surgery in his seminal article
describing a series of transgastric peritoneoscopies performed
in a swine model [24]. The stomach has many unique characteristics that make it appealing as a natural orifi ce from
which to access the abdominal cavity. Its muscular wall is
uniquely suited to the shearing forces associated with endoscopic intervention. Further, the anterior gastrotomy provides for access to the entire abdominal cavity. However, as
with the transvaginal approach, a transgastric procedure is
not without its risks. Outside of the incorporation of a gastrotomy into a gastrostomy tube, resection, or a traditional
surgical closure, there is no safe and reproducible means to
close the endoscopically created gastrotomy endolumenally.
Furthermore, the gastric milieu is inherently contaminated
and infectious risk is less well documented than with transvaginal access techniques.
Animal data
While many have concentrated their efforts on identifying
novel applications for the transgastric route to accessing the
abdominal cavity, few have approached the validation of
transgastric NOTES through the systematic identifi cation of
questions related to this methodology and creation of studies
to answer them. The fi rst obstacle that must be addressed is
the infectious risk of cross -contamination of the peritoneal
cavity with gastric contents. Additional issues fundamental
to this approach include: what is the impact of a transgastric
NOTES procedure to the subject ’s immune system? What is
the level of cross -contamination of the abdominal cavity
during transgastric passage of the endoscope? Does the
stomach or oropharynx require lavage prior to gastrotomy
and if so, what solution should be used to decontaminate
these areas?
Using a porcine model, McGee et al. attempted to address
the systemic immune response to a transgastric NOTES procedure [25]. In their study they compared a transgastric
peritoneoscopy to exploratory laparoscopy, exploratory
laparotomy, and a sham control. In each subject, TNF -α,
IL-1α, and IL -6 levels were sampled pre -operatively, at the
completion of the procedure, and at one hour, two days, and
fourteen days postoperatively. All animals underwent a
sterile surgical preparation. In addition, a high -volume
normal saline gastric lavage was completed prior to the
endoscopic gastrotomy. For this study, endoscopic equipment was decontaminated with 0.55% orthophthalaldehyde solution, but was not considered sterile. They found
that there was no difference in the levels of circulating IL -1α
and IL -6 between the three experimental groups. Perhaps
more importantly, there was a statistically signifi cant difference in the level of TNF -α detected in the blood, with the
transgastric NOTES cohort having the lowest levels. While
the clinical signifi cance of this may be debated, it is clear
that the systemic infl ammatory response to transgastric
NOTES is, at worst, equivalent to a laparoscopic or open
approach to the abdominal cavity.
One of the principal areas of investigation and debate for
the transgastric approach has been what level of decontamination is needed prior to passage of the endoscope. Furthermore, do the efforts to dilute or sterilize the gastric effl uent
have any impact clinically? In an effort to answer this question, Eickhoff designed a study that utilized an antibacterial
protocol for infection prevention for the experimental arm.
This group of eight pigs received 40 mg esomeprazole intravenously for chemical peritonitis prevention [26]. Further,
they were given prophylactic doses of cefuroxime and metronidazole. They then underwent oral and gastric lavages
with chlorhexidine 2% followed by gastric irrigation with
diluted antibiotic containing neomycin. The control group
underwent gastric cleansing with sterile saline only. Cultures
were performed at the end of the transgastric procedure to
assess for bacterial load. They found that there were signifi cantly more positive cultures and higher bacterial loads in
the samples taken from the control groups directly following
the operation and at necropsy fourteen days later. Further,
two of the control animals exhibited evidence of minor
31
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