Is a 43 year old patient who was

Is Transvaginal Natural Orice Translumenal Endoscopic Surgery the
future of Cholecystectomy
Sailee Sansgiri, [email protected]
Mahdieh Shojaei Baghini, [email protected]
Abstract — A systematic study on cholecystectomy performed
through Vaginal Natural Orice Transluminal Endoscopic
Surgery (vaginal NOTES) and its feasibilty as a future pro-
cedure for scarless surgery.
The Natural Orice Surgery Consortium for Assessment
and Research (NOSCAR) was founded in 2005, consisting
of members from The Society of American Gastrointesti-
nal Endoscopic Surgeons (SAGES) and American Society
of Gastrointestinal Endoscopy (ASGE) 1
. They proposed
the term NOTES (natural orice transluminal endoscopic
surgery) for “surgery performed using instruments which
gain access through a natural orice” 2
NOTES is performed by introducing instruments in the
body cavity (usually the peritoneal cavity) by gaining access
through a natural orice such as the mouth,urethra, vagina or
anus, as opposed to percutaneous access 2
.This is in contrast
to traditional laparotomy, where one large incision is made in
the abdominal wall, or laparoscopic surgery, where a small
incision is made in the abdominal wall to allow a laparoscope
to enter 3
. Hybrid NOTES combine NOTES with direct
transcutaneous access to the abdominal cavity, usually in
combination with laparoscopic instrumentation 2
. NOTES is
known to improve the cosmetic outcome, and also reduce
surgical injury. This, in turn decreases the inammatory
and neuroendocrine response resulting in less post-operative
pain and quicker recovery 4
. incorporating the applicable
criteria that follow. In 2007 Zorron et. al. performed the rst
transvaginal NOTES for cholecystectomy on a 43 year old
patient who was discharged within 48 hours of surgery. The
operative procedure is close to that of the Hasson technique
Regarding NOTES access to the peritoneum, the posterior
fornix of the vagina is described to have the lowest risk
of infections post-operatively, but the long-term risks to
fertility and dyspareunia remains unclear 5
. However, follow
up studies have occured in the case wherein 68 patients(mean
age 50 years) were interviewed 3-10 months post-surgery and
none reported any discomfort during sexual intercourse 6
According to a study by Yoshiki(2017), The vagina can
be easily decontaminated and provides direct access to the
peritoneum as it has no interposed organ or anatomical
structure. Trans-vaginal procedures mandate an incision in
the vaginal wall, which has been approved as safe and easy
to close. With regard to closure of the perforation site within
the natural orices, an acceptable closure method is not
yet present in any other access site except the vagina. He concludes that the transvaginal port is the most reliable for
NOTES in humans.7
A. Search Methodolgy Google Scholar, PubMed, and Cochrane databases were
used for collection of relevant articles and studies (including
randomized control trials). A smart search was performed
using the keywords: “cholecystectomy” AND/OR “vaginal”
AND “NOTES” . Searches were limited to English. Seven
randomised trials were found out of which two were ex-
cluded since the procedure adopted was Hybrid NOTES. All
years of publication were included in the search.
B. Types of articles included Articles were either systematic reviews, clinical trials,
established medical articles, surveys, perception studies, case
control studies, and case series. The participants were chosen
by random allocation. Obese patients and patients with
previous gall bladder surgeries were excluded from the study.
One porcine model study was included as well.
C. Types of data collected The quantitative parameters that were included were length
of operation (LOS), postoperative pain (measured on a Visual
Analogue Scale, or VAS), length of stay (non Intensive Care),
number of cases with intra and post-operative complications,
number of patients opting for analgesics post discharge,
and conversion to open surgery or standard laparoscopy.
The qualitative parameters that were included were scarring,
sexual function, fertility, and dietary change(s).
D. Quality Analysis The quality of the articles was assessed and implemented
in a PRISMA (Preferred Reporting Items for Systematic
Reviews and Meta-Analyses) ow diagram. A total of 12
articles were left after screening which we have further
utilized to discuss the effect of transvaginal NOTES on
cholecystectomy. The papers ranged from 2005-2018.
The criteria for inclusion were: patients with no surgical
comorbidities, non-obese patients (Body Mass Index
(BMI)¿=30 kg/m2), patients with no multiple procedures
(only cholecystectomy), middle-aged (to reduce risks
of infertility), patients with a vagina, and articles and
studies in English. For better clarity we have included
studies with control trials (Vaginal NOTES vs Conventional

Fig. 1. PRISMA Flow Diagram
A. Surgical Process To describe the surgical instruments used in pure
transvaginal NOTES, we have isolated 2 reports, which were
reportedly one of the rst few surgeries for cholecystectomy.
Gumbs et al(2009) performed the surgery on one patient,
with colpotomy and subsequent introduction of a trocar under
direct vision into the abdominal cavity. A 15-mm port was
established through the colpotomy, which was used to create
the pneumoperitoneum. A double channel gastroscope was
then introduced. An extra 5-mm port was placed beside the
15-mm port to allow placement of a curved retractor. The
cystic duct and artery were clipped using endoscopically
placed clips and the gallbladder was removed through the
vagina. The colpotomy was then closed with absorbable
sutures. The duration for the entire procedure was 185
minutes.9 The authors reported that the main problem was
to get a real safe view as the gastroscope is inserted from
behind and there some risk of biliary duct lesions.10 The
patient was discharged within 23 hours post surgery, and had 2 follow-ups, one after 2 weeks of the surgery and one after
4 weeks. In both the follow-ups, the patient reported no pain,
no post-operative complications, followed a regular diet and
did not need any pain medication. However, it is important
to note that the patient reported pain of around 7(out of 10)
on the Universal pain assessment tool immediately after the
De Sousa et al11 published 4 pure NOTES transvaginal
cholecystectomies in 2004. Transvaginal NOTES access was
obtained by direct vaginal incision, and two endoscopes
were simultaneously introduced in the abdominal cavity.
The pneumoperitoneum was established connecting a exible
tube to a standard gastroscope that was inserted through
a 2.5 cm posterior colpotomy. A second colonoscope with
two operative channels was inserted using the same access.
Dissection was accomplished with available endoscopic in-
struments. Ligation of cystic duct and artery was performed
using endoscopic clips. Vaginal closure was achieved using
the direct-vision sutured technique.The authors considered
the view and the spatial resolution to be of good quality.
The main problem was represented by the introduction of
working tools through a small access (the vagina) and the
lack of triangulation.10
B. Operative outcomes First and foremost, NOTES is considered
to be more cosmetic than Laparoscopy,
simply because it involves no external inci-
The primary advantage of this route is that it reduces
the risk associated with standard laparoscopy (bile
leakage, infections, and post operative pain due to
residual effects of CO2). According to an article about
a multicenter clinical trial comparing transvaginal and
oral NOTES, the principal investigator stated that
“Post-operatively, many patients experience pain while
walking or coughing due to contraction of the abdominal
muscles. This discomfort is absent following the natural
orice approach” with regards to gallbladder removal
oral-gallbladder-surgery.aspx The transvaginal route
has been proven to be the most effective route in a
cholecystectomy. According to Michelle et. al. a natural
orice entry reduces risks of infection, intraoperative
hernias with a complication of just 1.5According to
Andol et al, in 714 NOTES surgeries, the average
length of stay in the hospital was 1.9 days Marerscaux
et. al. performed a TVC on one female patient after
which the patient had no scarring and was discharged
on the day of the surgery (https://www-tandfonline-
A one month follow up detected no complications.
According to Hensel (https://www.thieme- there
was a signicant reduction in consumption of opiates
(p¡0.001) and peripheral analgesics (p ¡0.001).
However, due to its steep learning curve and

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availability of instruments, along with sociological barriers
transvaginal NOTES is yet to be accepted as a standard
procedure for gall bladder removal surgery. Gumbs et
al have reported that one of the greatest disadvantages
of this technique is ” difculty in obtaining the “critical
view of safety,”” and lack of triangulation of instruments
during the surgical procedure. Most surgeons currently
do not possess the knowledge and skill to perform to
perform NOTES14 Similarly, exible laparoscopes are
not familiar to most surgeons, and surgical techniques and
procedures are not familiar to most gastroenterologists,
more specically for the transvaginal approach14. In
a study conducted by Adler et al(2017) that compared
transvaginal cholecystectomies to traditional laparoscopic
surgery( 226 laparoscopic cholecystectomies vs 90 NOTES
transvagnal cholecystectomies, all done by the same
surgeon), no intraoperative complications were observed in
laparoscopy, whereas there were 3 instances of complications
(bleeding in 2, gallbladder rupture in 1)during the NOTES
procedures.15 According to Freeman et al(2011), It has
been concluded in this study that NOTES procedures result
in longer operative times in the early part of the learning
curve and require considerable experience before reaching
A. Morbdities Fertility and dyspareunia: Although there is no
supporting literature to prove that transvaginal NOTES
has indeed had an adverse effect on the fertility
of a patient, in a study conducted by Thele et
2008-1077379), a questionnaire was presented to
heads of gynaecological departments in 181 hospitals,
and 44.2Furthermore, according to Targarona et
the complications of transvaginal cholestectomy should
logically resemble those of transvaginal hysterectomy and
fertiloscopy. In the same article, a study by Nasif et al is
referenced, wherein dyspareunia is reported in 2
-Risk of biliary duct lesions: Gums et al reported that
there was a risk of binary duct lesions during surgery while
placing a transvaginal retractor during transvaginal cholecys-
tectomy(here) -Internal abdominal injuries during surgery: –
Operative errors: -conversion to open surgery: conversion to
4-port surgery(3.7
B. Perception in patients Regarding perception of NOTES in patients, A study
conducted by Verlaan et al(2011) gauged the perception
of patients with regards to bariatric surgery. This study
noted that low complication risk was the most important
criteria for patients, followed by quick recovery , intensity
of postoperative pain, the duration of pain , length of
hospital stay and nally, post-operative scars. Most of the
patients preferred a laparoscopic procedure above NOTES. Patients with high education chose a NOTES procedure
more often than patients with low education. Zornig
et al
reported that 10% of patients were not satised with their
scars after laparoscopic cholecystectomy, but no similar
complaints occurred in the TVC group. According to
Varadarajulu et al (2008), patient preference for NOTES
cholecystectomy was 100% if overall complications were
¡3%. However, they preferred the oral route most (81% of
the women in the survey), as opposed to the transvaginal
route. The same can be echoed by a study by Chiu et al,
that stated that due to cultural variances, the acceptance
of transvaginal procedures is much lower in Asian
countries17. In Asian countries, despite the extensive
research and progress in TVC, there is a cultural bias
which makes the vaginal route the least preferred route for
Furthermore, gynaecologists believe that patients over the
age of 50 are most suitable for this approach, which
decreases our sample size even further.
Our Recommendation Category for pure NOTES (based
on the scale used by U.S. Preventive Services Task Force) is
currently at Level C (At least fair scientic evidence suggests
that there are benets provided by the clinical service, but the
balance between benets and risks are too close for making
general recommendations)
Appendixes should appear before the acknowledgment.
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O. Avoid the stilted
OOne of us (R. B. G.) thanks . . . ´
O Instead, try

OR. B. G. thanks ´
O. Put sponsor acknowledgments in the
unnumbered footnote on the rst page.
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