Notes

NOTES
NATURAL ORIFICE TRANSLUMINAL
ENDOSCOPIC SURGERY
THE NEXT GENERATION OF ‘LEAST INVASIVE
SURGICAL THERAPY’
NATURAL ORIFICE TRANSLUMINAL
ENDOSCOPIC SURGERY
THE NEXT GENERATION OF ‘LEAST INVASIVE
SURGICAL THERAPY’

NOTES:DEFINITION
An experimental surgical
technique - "scarless"
abdominal operations
performed with an multi-
channel endoscope
passed through a
natural orifice (mouth,
urethra, anus, vagina
etc.)

NOTES: HISTORY
 The potential of flexible endoscopy to
perform therapeutic procedures beyond the
wall of GIT was recognized as early as 1980
when the first transluminal feeding
gastrostomy was described by Gauderer et
al.
 Kozarek et al published the first report of
successful endoscopic drainage of
pseudocyst in 1985

NOTES: HISTORY
 The first report of oral
peritoneoscopy done in animals
was published by Kalloo et al. in
2004.
 In September 2007, Novare announced
the successful completion of the first
NOTES gallbladder removal

NOTES: HISTORY
 In March 2008, Dr Ricardo Zorron,
of Brazil, performed the first series of
NOTES cholecystectomy on four
patients via transvaginal route
transgastric appendectomy in
humans in India By Dr. G V Rao
and Dr. N Reddy. (Hyderabad,
India)

NOTES: HISTORY
Since then, multiple investigators
have used transluminal
endoscopy
in animal models to perform
various intraperitoneal surgical
procedures, ranging from tubal
ligation to splenectomy.

NOTES:THE IDEA
 Idea of NOTES-developed in response to facts that
patients would-
1) realize the benefits of this least invasive
technique of surgery.
2) experience less physical discomfort than
traditional procedures.
3) have virtually no visible scarring following this
type of surgery.
NOTES, with its general idea to minimizing the trauma.

NOTES:THE CONCEPT
By avoiding incisions on the abdominal
wall,
 risks of infection,
 pain and
 disability
will be minimized and

recovery either
shortened or
eliminated.

NOTES: THE CONCEPT
 NOTES - safe and feasible
 same efficacy as traditional
laparoscopic procedures. decreased
neurohumoral stress response
Various advantages like
 decreased immunosuppression
 less pain
 faster recovery
 decreased incidence of wound-related and
pulmonary complications
have been recognized

 Wound infection is a common surgical complication, with a
reported incidence ranging between 2% and 25%,
depending on the type of surgery performed.

 Eliminating all skin incisions would completely eliminate this
risk.
 Incisional hernias and increasing rates of postoperative
adhesions are thought to correlate with the size of
abdominal wall incision.
 The incidence of incisional hernia is substantially lower with
laparoscopic procedures, where incision size is much smaller
than for open surgery, and should be eliminated with NOTES
(4%–18% with open surgery vs 0.2%–3% with laparoscopic
surgery).

 Similarly, the reported rates of small-bowel obstruction due
to adhesions are also significantly lower after laparoscopic
surgery compared with open surgery (3.3% vs 7.7%) and will
perhaps be further decreased with NOTES
 Other potential benefits that NOTES has been theorized to
offer are
• decreased postoperative pain
• less need for postoperative analgesia
• shorter hospital stay
• faster recovery.
 Additionally, It may provide an easy alternative access to
the peritoneal cavity in morbidly obese patients, in whom
traditional open or laparoscopic access can be difficult
because of abdominal wall thickness, and could possibly
reduce the lifetime risk of incision-related complications in
children.

 To head off errors and to develop NOTES in a
responsible and safe manner, a working group of 14
leading laparoscopic surgeons and endoscopists
from the Society of American Gastrointestinal
Endoscopic Surgeons (SAGES) and the American
Society for Gastrointestinal Endoscopy (ASGE) met in
July 2005.
 The working group was named Natural Orifice
Surgery Consortium for Assessment and Research
(NOSCAR).

 The prime goal of the meeting was to
produce a document that would serve as
a guide for responsible development of
NOTES.
 In the white paper that the group
subsequently published, NOSCAR
discussed in detail the potential
challenges to safe use of NOTES in clinical
practice and outlined guidelines for
investigators working on NOTES and
criteria for expanding participation in
NOSCAR

NOTES: INSTRUMENTS
The Transport advanced operating endoscope
[USGI Medical, San Juan Capistrano, California].

NOTES: INSTRUMENTS
Triangualation principle
used in laproscopic
surgeries
The Cobra triangulating scope
[USGI Medical, San Juan
Capistrano, California].

NOTES: INSTRUMENTS
The Olympus R [Olympus,
Center Valley, Pennyslvania]
is a commercially
available dual channel
operating scope.

More robust flexible instruments will
allow surgery to be performed
endoscopically.
The Eagle Claw
[Olympus, Center Valley, Pennsylvania]
suturing device with a semi-circular
needle.

The Swain
closure system
[Ethicon,
Cincinnati, Ohio]
uses a pair of
T-tags and a
sliding cynch
for full
thickness
closure.
Closure of a NOTES gastrotomy using the
g-prox system [USGI Medical, San Juan
Capistrano, California].

NOTES Internal incision is over
 stomach,
 vagina,
 bladder or
 colon,
thus completely avoiding any external incisions or scars.

NOTES: ROUTES
NOTES has been
mostly practised
on animals, for diagnosis
and treatments, including
transgastric organ
removal.

NOTES: ROUTES
Acc. To some transvesical and
transcolonic approaches- more suited to
access upper abdominal structures,
which are often more difficult to work
with if using a transgastric approach.

NOTES:ROUTES
Transvaginal access appears to
be the safest and most feasible.
potentially
less complications,
but only possible in women.

 It is very important that the closure device and
the technique be easy to use and provide a nearly
100% secure closure of the enterotomy site.
Complications of enterotomy leakage will create
a big hurdle to the safe clinical use of NOTES.
 It is widely accepted that given the safety of
laparoscopic approach, an enterotomy leak rate of
even 1% would be unacceptable.

Currently available flexible endoscopes
are inadequate for performing complex
transluminal surgical procedures.
Issues with current flexible scopes include
 lack of a multitasking platform,
 the number and size of access channels
 inability to position and then fix or “stiffen” the
endoscope to allow robust retraction and
exposure
 inability to control insufflation pressures
 fixed visual horizons that force the surgeon to
adjust to tilted or inverted
 inadequate suction/irrigation capabilities

Transvaginal natural orifice transluminal
endoscopic surgery for adnexal masses
Yun Seok Yang1,*
, Myung Haeng Hur2
,Kwoan Young Oh1
and Soo Young Kim3
Article first published online: 22 JUL 2013
Abstract
Aim
Natural orifice transluminal endoscopic surgery (NOTES)
is currently a very important topic for surgeons.
This study aimed to describe the initial clinical experience
of transvaginal NOTES for adnexal masses and investigate
its feasibility and surgical outcome.

Methods
 they performed transvaginal NOTES in 7 patients
with adnexal masses through a 2-cm incision in the
posterior vaginal fornix.
 A transvaginal NOTES system comprising a wound
protractor and a surgical glove with sheaths was
used.
 Resection was performed according to the method of
standard laparoscopic adnexal surgery.
 The adnexal mass was removed via the incision of the
posterior vaginal fornix after complete resection.

 Results
 Since June 2011, 7 patients have undergone transvaginal NOTES for
adnexal masses.
 All cases were completed successfully without conversion to
standard laparoscopic approach.
 The median age of the patients was 48 years (range, 36–60) and the
median body mass index was 23.6 (range, 20.4–25.3).
 The median tumor size was 6cm (range, 3.7–6.7). The median
operative time was 45min (range, 40–80).
 The estimated blood loss was minimal (range, 5–300mL). The
median postoperative hospital stay was 2 days (range, 1–3).
 No postoperative complications were observed at follow-up.
 All the patients were very satisfied with the cosmetic result.

Conclusion
 The findings show transvaginal NOTES with
our method to be a feasible, safe and effective
surgical technique that results in excellent
cosmesis.
 It may be an alternative technique for the
treatment of properly selected female patients
with adnexal masses.
 More experience and instrumental
improvement suitable for transvaginal NOTES
are needed

Laparoendoscopic Single-site and Natural
Orifice Transluminal Endoscopic Surgery in
Urology: A Critical Analysis of the Literature
European Urology, Volume 59 Issue 1, January 2011, Pages 26-45
Published online: 01 January 2011
 Abstract
 Context
 Natural orifice transluminal endoscopic surgery (NOTES)
and laparoendoscopic single-site surgery (LESS) have
been developed to benefit patients by enabling
surgeons to perform scarless surgery.
 Objective
 To summarize and critically analyze the available
evidence on the current status and future perspectives
of LESS and NOTES in urology.

 Evidence acquisition
 A comprehensive electronic literature search was conducted in
June 2010 using the Medline database to identify all
publications relating to NOTES and LESS in urology.
 Evidence synthesis
 In urology, NOTES has been completed experimentally via
 transgastric,
 transvaginal,
 transcolonic, and
 transvesical routes.
 Initial clinical experience has shown that NOTES urologic surgery
using currently available instruments is indeed possible.

 Nevertheless, because of the immaturity of the
instrumentation, early cases have demanded high
technical virtuosity.
 LESS can safely and effectively be performed in a
variety of urologic settings.
 As clinical experience increases, expanding
indications are expected to be documented and
the efficacy of the procedure to improve.
 Prospective, randomized studies are largely
awaited to determine which LESS procedures will
be established and which are unlikely to stand the
test of time.

Transvaginal
Advantages:
- En face visualization of upper urinary tract
- Ease of closure
- Use of both flexible and rigid instruments
- Highly compliant (specimen retrieval)
Disadvantages
-Only available in female
- Lack of sterility (risk of infection)

Transgastric
 Advantages
- Available in both genders
 Disadvantages
- Lack of sterility (risk of infection)
- Lack of reliable closing system
- Exclusive use of flexible instruments
- Difficult spatial orientation
-Specimen retrieval (limited)

Transcolonic
 Advantages
- Highly compliant (specimen retrieval)
 Disadvantages
- Highly contaminated (risk of infection)
- Lack of reliable closing system

Tansvesical
 Advantages
- Sterility
 Disadvantages
- Limited luminal diameter (specimen
retrieval not allowed)

 All routes are under experimental
usage
 Where as in clinical application of
urology presently only transvaginal
and transvesical are being used

 Conclusions
 NOTES is still an investigational approach in
urology.
 LESS has proven to be immediately applicable in
the clinical field, being safe and feasible in the
hands of experienced laparoscopic surgeons.
 Development of instrumentation and application
of robotic technology are expected to define the
actual role of these techniques in minimally
invasive urologic surgery.

BJU Int. 2013 Jan;111(1):11-6.
Natural orifice transluminal endoscopic surgery
(NOTES): where are we going? A bibliometric
assessment.
Autorino R1
, Yakoubi R, White WM, Gettman M, De Sio M, Quattrone C, Di
Palma C, Izzo A, Correia-Pinto J, Kaouk JH, Lima E.
 The aim of this study was to analyse natural orifice
transluminal endoscopic surgery (NOTES)-related
publications over the last 5 years.
 A systematic literature search was done to retrieve
publications related to NOTES from 2006 to 2011. The
following variables were recorded: year
of publication

• A time-trend analysis was performed by comparing early
(2006-2008) and late (2009-2011) study periods.
• Overall, 644 publications were included in the analysis
and most papers were found in general surgery journals
(50.9%).
• Studies were most frequently clinical series (43.9%) and
animal experimental (48%), with the articles focusing
primarily on cholecystectomy, access creation and
closure, and peritoneoscopy.
• Pure NOTES techniques were performed in most of the
published reports (85%) with the remaining cases being
hybrid NOTES (7.4%) and NOTES-assisted procedures
(6.1%).

• The access routes included
transgastric (52.5%),
transcolonic (12.3%),
transvesical (12.5%),
transvaginal (10.5%), and
combined (12.3%).
• Pure NOTES remained the most studied
approach over the years but with increased
investigation in the field of NOTES-assisted
techniques (P = 0.001).
• There was also a significant increase in the
adoption of transvesical access (7% vs 15.6%) (P =
0.007).

• NOTES is in a developmental stage and much work
is still needed to refine techniques, verify safety and
document efficacy.
• Since the first description of the concept of NOTES,
>2000 clinical cases, irrespective of specialty, have
been reported.
• NOTES remains a field of intense clinical and
experimental research in various surgical
specialities.

Transgastric and Transvaginal
Endoscopic Cholecystectomy
in Human Beings
 INTRODUCTION:
 Since the first reports in the 80’s, laparoscopy has
become the standard for cholecystectomy.
 Now a natural orifice approach to the peritoneal cavity
may further reduce the invasiveness of surgery.
 Several orifice routes to the abdominal cavity have
been described: transgastric, transvaginal, transvesical
and transcolonic.
 The authors present their experience with transgastric
(TG) and transvaginal (TV) cholecystectomies in human
beings.

 METHODS AND PROCEDURES:
 27 patients(1 male and 26 females)
underwent hybrid NOTES procedures from
January 2007 to September 2008.
 The mean age was 47 yr (20-83).
 The BMI ranged 21-41 and ASA I-II.
 Transgastric cholecystectomy was performed
in 15 patients and 12 patients had a
transvaginal cholecystectomy.

 RESULTS:
 The mean operative time was 139 min.
 Although operative times were slightly shorter in
the TG group, 132 min ± 35.7 (75-190) when
compared to the TV route, 147 min ± 31.5 (95-
220), there were not significant differences
between the two groups (p=0.3, Mann Whitney U
test).
 This may be not real because in TV procedures
we did more endoscopic steps and in TG
procedures were more laparoscopic because TG
is challenging.
 Patients were started on liquids within an hour
and discharged two hours later.

 An overall 25 % morbidity rate and no mortality
were found.
 The complication rates for the TG and TV groups
were 26 % (4/15) and 25 % (3/12) respectively,
which was not statistically significant (p=0.5, chi-
square test).
 66% of complications occurred the 1st
yr and 33 %
the 2nd year of our experience.
 These complications were:
 biliary leakage,
 hematoma of greater curvature,
 abdominal sepsis,
 colon injury secondary to the vaginal closure,
 wound infection and
 laceration of the esophageal mucosa.

 These complications were:
 biliary leakage,
 hematoma of greater curvature,
 abdominal sepsis,
 colon injury secondary to the
vaginal closure,
 wound infection and
 laceration of the esophageal
mucosa.

 The hematoma required conversion to
open procedure,
 the colon injury was repaired
laparoscopically
 while the biliary leakage and
abdominal sepsis were managed both
by relaparoscopy after readmissions.
 The intraperitoneal fluid in the septic
patient was cultured and Streptococcus
faecalis was found.
 3 patients (11 %) were readmitted for
biliary leakage, abdominal sepsis and
pain management.

 CONCLUSIONS:
 Transgastric and transvaginal
cholecystectomies are feasible.
 Although these NOTES procedures were
laparoscopically-assisted and current flexible
endoscopes were used, it seems possible that
major intraabdominal surgeries may one day
be performed without skin incisions, but a
learning curve is mandatory.
 These trends toward incisionless surgery
demands coordinated research in an
interdisciplinary setting, involving both
surgeons and device manufacturers.

World J Surg. 2014 Jan;38(1):25-32. doi: 10.1007/s00268-013-2221-4.
Single-incision and NOTES cholecystectomy, are there
clinical or cosmetic advantages when compared to
conventional laparoscopic cholecystectomy? A case-
control study comparing single-incision, transvaginal,
and conventional laparoscopic technique for
cholecystectomy.
van den Boezem PB1
, Velthuis S, Lourens HJ, Cuesta MA, Sietses C
 Abstract
 BACKGROUND:
 The aim of the present study was to compare the
clinical and cosmetic results of transvaginal hybrid
cholecystectomy (TVC), single-port
cholecystectomy (SPC), and conventional
laparoscopic cholecystectomy (CLC).

 Recently, single-incision laparoscopic surgery
and natural orifice transluminal endoscopic
surgery have been developed as minimally
invasive alternatives for CLC. Few comparative
studies have been reported
 Methods:
 Female patients with symptomatic gallstone
disease who were treated in 2011 with SPC,
TVC, or CLC were entered into a database.
 Patients were matched for age, body mass
index, and previous abdominal surgery.
 After the operation all patients received a
survey with questions about recovery,
cosmesis, and body image.

 Results:
 total of 90 patients, 30 in each group, were evaluated.
 Median operative time for CLC was significantly shorter
(p < 0.001).
 There were no major complications.
 Length of hospital stay, postoperative pain, and
postoperative complications were not significantly
different.
 The results for cosmesis and body image after the
transvaginal approach were significantly higher.
 None of the sexually active women observed
postoperative dyspareunia

 Conclusions:
 Both SPC and TVC are feasible procedures when
performed in selected patients.
 CLC is a faster procedure, but other clinical
outcomes and complication rates were similar.
 SPC, and especially TVC, offer a better cosmetic
result
 Randomized trials are needed to specify the
role of SPC and TVC in the treatment of patients
with symptomatic gallstone disease

Conclusions
 Surgery is evolving beyond current flexible
endoscopic and laparoscopic approaches.
 NOTES may represent the next phase of minimally
invasive surgery, and early clinical experience
shows that intra-abdominal surgery using flexible
endoscopes is indeed possible.
 Because of the immaturity of the instrumentation,
early cases demand a technical virtuosity that
probably precludes a widespread application of
this approach. This balance will shift as enabling
technologies are developed.

 Nevertheless, NOTES will always be more technically
demanding than open or laparoscopic surgery.
 If definite patient benefits are documented, if the
public begins to demand “incision-less” surgery, or if
both are the case, practitioners will need to master
these techniques.
 Yet to be resolved is who will perform NOTES—
gastroenterologists or surgeons versus a new breed of
surgical endoscopists. The answer will depend on which
procedures are shown to merit a NOTES approach
(high-volume “bread and butter” procedures or
esoteric tertiary-center procedures), as well as on how
issues such as credentialing and malpractice are
resolved.

NOTES:Current Challenge
Change is part of
surgery but it is never
easy to accept.

NOTES
witnessing a true remarkable shift in our
lifetime i.e. Natural Orifice
Transluminal Endoscopic Surgery
(NOTES).

Notes

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