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204
S.F. Majid et al.
made many procedures less invasive, safer, and cosmetically more acceptable. The
idea of scarless surgery has now become a great challenge for the whole medical
environment.
But this is nothing new. A desire to evaluate the inside of a patient’s abdomen or
chest with limited injury existed as far back as Hippocrates (460–375 BC). In the
1960s, Kurt Semm, a German gynecologist, invented the automatic insuf fl ator. He
performed an appendectomy during a gynecological procedure and opened a large
door for a new surgery, and was almost removed from the Germany Physician
Society because of it. In 1970, after Dr. Semm became the chairman of Obstetrics
and Gynecology at the University of Kiel, his co-workers demanded that he undergo
a brain scan because, they said, “Only a person with brain damage would perform
laparoscopic surgery” [
1– 4 ] .
Natural ori fi ce translumenal endoscopic surgery (NOTES) is a novel surgical
technique that may improve patient outcomes in minimally invasive surgery. The
clearest bene fi t is cosmetic because surgeons use the body’s natural ori fi ces for
access rather than transfascial incisions. Leaders in gastroenterology and surgery
anticipate that NOTES will reduce the incidence of hernia and may improve pain
and recovery [ 5 ] .
In much the same way as laparoscopy 20 years ago, NOTES de fi es conventional
surgical practices and has been the subject of some appropriate skepticism. In 2004,
Kalloo et al. [ 6 ] described NOTES in an animal model as a potential next step in the
evolution of therapeutic endoscopy. Although several variations of natural ori fi ce
operations predate the work of Kalloo et al. [ 6, 7 ] , it was their fi rst experiments that
sparked the current heavy interest in NOTES.
In response to the clinical potential of NOTES, leaders from the pertinent sur-
gery society [Society of American Gastrointestinal and Endoscopic Surgeons
(SAGES)] and the American Society for Gastrointestinal Endoscopy (ASGE) gen-
erated a white paper that encouraged further NOTES research and outlined key
research areas that needed to be addressed [ 8, 9 ] . This outline, generously funded,
has led to a body of preclinical work over the past few years. Notably, leaders agreed
that all NOTES cases be collated in a central database to ensure the accurate report-
ing of outcomes and to provide early evidence of important trends regarding the
safety of NOTES.
A large body of preclinical evidence now exists, demonstrating that several types
of NOTES operations can be performed in both acute and survival animal models
through a variety of approaches, including access via the stomach, rectum, vagina,
esophagus, and bladder. The NOTES procedure has moved quickly from a concept
to preclinical studies to human clinical trials based on this preclinical work
[
10– 14 ] .
At the University of California, San Diego (UCSD)’s Center for the Future of
Surgery, we invested nearly 2 years in preclinical research using both animate
and anatomic material models to maximize patient safety and prepare the way
for a clinical trial. Evidence from this intensive work was central to the success-
ful application to the IRB. We described a dual-view hybrid NOTES technique
205
16 NOTES: Cholecystectomy (U.S. Experience)
previously, which we believe maximizes safety [ 15 ] . The vagina was selected
initially as the safest access point for NOTES. Close consultation with the uni-
versity’s Reproductive Medicine and Gastroenterology departments was central
to our planning of human NOTES operations. In the rest of the chapter, we will
be focusing on our approach to NOTES cholecystectomies and the lessons we
have learned during this period.
Two separate protocols for performing NOTES operations for the purpose of
performing a cholecystectomy were approved by the IRB at UCSD. The transvagi-
nal and transgastric approaches were separated into different protocols. The exclu-
sion criteria for these approaches are:
1. Patients with a body mass index (BMI) greater than 35
2. Patients younger than 18 or older than 65
3. Patients with a history of severe endometriosis, pelvic in fl ammatory disease, or
ectopic pregnancy
4. Patients with known common duct stones or presumed gallbladder mass
5. Patients with prior open abdominal operations
6. Pregnant women
7. Patients with severe medical comorbidities
8. Patients with a history of vaginal trauma
9. Patients with clotting or bleeding disorders and patients receiving anticoagulant
or antiplatelet medications
Technique for Transvaginal Cholecystectomy
Patient Positioning and Preparation
General anesthesia is con fi rmed, sequential compression devices are applied, appro-
priate antibiotic prophylaxis is administered, and a nasogastric tube is placed. The
patient is positioned in the dorsal lithotomy position. The abdomen and vagina are
prepped in standard sterile fashion. A Foley catheter is placed on the operative fi eld
in sterile fashion.
Transvaginal Access and Establishment of Pneumoperitoneum
A 5-mm Visiport™ (Covidien, Dublin, Ireland) is placed at the umbilicus using an
open Hassan technique. The abdomen is insuf fl ated to 15 mmHg, and a diagnostic
laparoscopy is performed. The diagnostic laparoscopy serves the purpose of assess-
ing the presence or absence of adhesions both in the pelvis for a safe transvaginal
access as well as in the right upper quadrant around the gallbladder. If too much
206
S.F. Majid et al.
in fl ammation or adhesions are found during inspection, we recommend converting
to conventional laparoscopy.
Once the transvaginal approach is deemed feasible, the cervix is sequentially
dilated and a uterine sound placed to measure the cervical length. A uterine retractor
is used to lift the uterus and a 15-mm dilating, exchangeable head, dual-channel
trocar (Applied Medical, Rancho Santa Margarita, CA) is placed in the posterior
cul-de-sac. All this is performed under direct laparoscopic view. A sterile endo-
scope is placed into the abdomen. The dual-lumen trocar allows for placement of
the scope as well as a 5-mm rigid or fl exible instrument alongside the fl exible endo-
scope. A key risk to the placement of a vaginal trocar is the possibility of unrecog-
nized injury to nearby structures, particularly the rectum, sigmoid colon, bladder,
and ureters. Currently, laparoscopic vision is the best way to visualize the pelvis
directly to ensure that no injury occurs during transvaginal access.
Endoscopic insuf fl ation may be used to maintain a pneumoperitoneum, but
this approach is more dif fi cult to manage and measure than a standard laparo-
scopic port approach, which is speci fi cally designed for intraabdominal
insuf fl ation. A wider variation in pressure is observed than with laparoscopic
insuf fl ation [
16 ] . The transumbilical laparoscopic port and insuf fl ation system
ensures that any excess insuf fl ation is noted and quickly addressed. This port
also allows the passage of a single laparoscopic instrument into the abdomen for
use. Until better instruments are developed, having one port available for use
with well-developed minimally invasive instruments is important for safe natural
ori fi ce surgery at this stage.
Gallbladder Retraction
Adequate retraction undoubtedly serves as an obstacle when performing these sur-
gical procedures. Aside from its inevitable prolongation of operative time, inade-
quate retraction can potentially convert a technically straightforward case into a
complex ordeal. Minimally invasive surgeons all over the world have been attempt-
ing to create novel methods of accomplishing adequate retraction without leaving
any visible evidence of it. We will review some of the retraction methods here and
go over the salient features of each.
Endoscopic Graspers
Natural ori fi ce surgery requires more capability than current endoscopes offer.
Retraction of the gallbladder is dif fi cult with the currently available, fl imsy endo-
scopic graspers that do not maintain a secure purchase on the gallbladder wall.
Furthermore, dedicating one channel of an endoscope to retraction limits vision
and prohibits use of that channel by a tissue manipulation instrument through a
second channel.
207
16 NOTES: Cholecystectomy (U.S. Experience)
Articulating Graspers
A long articulating grasper (Fig. 16.1 ) placed adjacent to the endoscope through a
second channel via a common port (developed by UCSD and Novare Endosurgical,
now available from Intuitive Surgical, Sunnyvale, CA) allows for strong and fl exible
retraction independent of and offset from the endoscopic platform. This instrument,
a 75-cm-long device, features a cable system that allows for fl exibility at the tip and
extra degrees of freedom, similar to the wrist of the da Vinci
®
robotic surgical sys-
tem (Intuitive Surgical, Sunnyvale, CA). This device provides enough rigidity for
strength of retraction, but with some fl exibility to optimize exposure, and the
strength of its grip on the gallbladder wall vastly exceeds that of an endoscopic
grasper.
Transabdominal Stay Sutures
The sutures are placed through the fundus and infundibulum of the gallbladder
using a straight Keith needle and then externalized in a transabdominal fashion to
allow continuous extracorporeal manipulation, leaving only a negligible mark where
the needle passed through the skin [ 17 ] . One limitation of the transabdominal stay-
suture method of retraction is restricted retraction capability. In order to avoid enter-
ing the thoracic cavity and potential pneumothorax, the straight needle and stay
sutures must be inserted inferior to the rib cage, resulting in anterior rather than
Fig. 16.1 Long articulating
grasper (Developed by UCSD
and Novare Endosurgical,
now available from Intuitive
Surgical)
208
S.F. Majid et al.
complete anterior–superior retraction of the gallbladder fundus as performed in
standard laparoscopy. Another drawback of this method is the potential for intrap-
eritoneal bile leakage and possible rupture of the gallbladder as the needle must
pierce the gallbladder wall. In addition, because these stay sutures serve as a fi xed
anchoring system, repositioning during surgery is not possible without the repeated
passage of a second needle and suture [
18 ] .
Transabdominal Endoloop
®
The Endoloop
®
(Ethicon Endo-Surgery, Cincinnati, OH) is introduced transabdomi-
nally into the peritoneal cavity through a 5-mm trocar and attached to the gallblad-
der fundus, which is then retracted anteriorly toward the abdominal wall [ 18 ] .
Although similar conceptually to transabdominal stay sutures, an Endoloop pro-
vides two distinct advantages. First, because the Endoloop is used to grasp the gall-
bladder as opposed to piercing it, the potential for leakage and complete tearing of
the gallbladder is minimized. Nevertheless, like stay sutures, because it must be
introduced inferior to the rib cage, Endoloops cannot achieve complete superiorly
directed retraction. In addition, fastening of the Endoloops may prove challenging
in cases of scarred and distended gallbladders. The need for a 5-mm transabdominal
trocar for the insertion and usage limits the usefulness of this device in the trans-
vaginal approach.
R-Scope
The R-Scope (Olympus XGIF-2TQ240R, Olympus Corp., Tokyo, Japan) is a thera-
peutic endoscope equipped with two movable channels designed to enable both
lifting and dissection of lesions. One channel is fi tted with vertically moving grasp-
ing forceps to provide countertraction while the second uses a horizontally swing-
ing electrocautery knife to dissect [ 19 ] . Using these two channels enables
simultaneous retraction and dissection. Although initially used for endoscopic sub-
mucosal dissection of gastric lesions, Sumiyama et al. [ 20 ] report successful trans-
gastric access to the gallbladder and cholecystectomy in four porcine models.
Magnetic Anchoring and Guidance System
Magnetic anchoring and guidance system (MAGS), developed by the group of
Cadeddu and Scott in 2001 at UT Southwestern, employs intraabdominal magneti-
cally anchored instruments to perform trocar-sparing laparoscopic surgery
(Fig. 16.2 ). MAGS uses two internal neodymium–iron–boron magnetic platforms
introduced into the abdomen through a 12-mm trocar. The internal platforms are
magnetically anchored to external anchors on the patient’s skin and are capable of
manipulating and stabilizing these platforms [ 21, 22 ] . In Cadeddu’s retraction
209
16 NOTES: Cholecystectomy (U.S. Experience)
system, two internal magnetic platforms are coupled to either a latex sling or a
three- fi ngered paddle, which allows nontraumatic elevation and retraction of organs
like the liver and spleen. Ryou and Thompson [ 23 ] describe a modi fi ed MAGS
retraction system whereby magnet-conjugated clips placed along the inferior edge
of the liver are used to accomplish operative retraction. As yet, MAGS retraction
has been used successfully in porcine models to perform transcolonic cholecystec-
tomy and mesh implantation. In addition, MAGS instruments, cautery devices, and
cameras have been used in single-port laparoscopic nephrectomies, freeing up the
single port to be used for direct retraction [ 24 ] .
We have described the use of MAGS safely and effectively in four patients who
underwent transvaginal cholecystectomies [ 25 ] .
Internal Retractors
The EndoGrab
TM
(Virtual Ports, Misgav, Israel) (Fig. 16.3 ) is an internally anchored
retracting device that can be introduced into the abdomen at the outset of the opera-
tion through a 5-mm port. Once deployed, one of the two grasping ends is attached
to the gallbladder while the other is anchored to the abdominal wall. The main
advantage of this device is that it not only leaves no visible marks but also can be
anchored superiorly just below the diaphragm, thereby allowing retraction equiva-
lent to that achieved with a designated retracting instrument. This device can be
adjusted repeatedly throughout the operation to allow for optimal retraction and is
removed at the end of surgery.
Each retraction method has its disadvantages, and not all of them can achieve the
same degree of retraction, a point that becomes signi fi cant when less-than-ideal sur-
gical anatomy is encountered. The ability of the EndoGrab to accomplish complete
anterior and superior retraction of the gallbladder fundus is a distinct advantage over
Fig. 16.2 MAGS retraction
210
S.F. Majid et al.
other methods. Because it is internally deployed, it can be attached high on the ante-
rior abdominal wall just below the diaphragm without concern of entering the tho-
racic cavity. After being initially tested in porcine models, fi ve successful transvaginal
NOTES cholecystectomies were performed using this retraction device without com-
plication [ 18 ] . A 70-cm introducer will be available for positioning the EndoGrab
transvaginally, thereby obviating the need for transumbilical placement of the
EndoGrab. These internal retractors are also currently being employed for colon
retraction during colectomy and gastric retraction during sleeve gastrectomy.
Gallbladder Dissection and Ligating the Cystic Duct and Artery
Dissection of the gallbladder from the liver bed is dif fi cult using the endoscopic
needle hook or the L-shape hook device (Olympus America, Center Valley, PA).
Although it is possible to dissect the gallbladder from the liver bed using this hook,
its small size makes dissection cumbersome and lengthy. The use of a laparoscopic
hook from the umbilical port, at least for the dif fi cult portions of the dissection,
allows for a safer and quicker procedure compared with the endoscopic
counterparts.
Laparoscopic clips are absolutely necessary for patient safety. Endoscopic
clips are not entirely occlusive and are not designed to secure the cystic duct. The
a
b
Fig. 16.3 ( a ) EndoGrab; ( b ) loaded EndoGrab (Courtesy of Virtual Ports, Misgav, Israel)
211
16 NOTES: Cholecystectomy (U.S. Experience)
development of new endoscopic instruments may improve upon current instrumen-
tation, but until then, we believe the safest course is to use a single laparoscopic
access umbilical port.
Extraction of Specimen
The gallbladder is removed easily from the trocar, either with or without an
endobag.
Closure of the Vaginotomy
The abdomen is inspected and once good, hemostasis is con fi rmed. Using a vaginal
speculum, the incision is easily visualized, and a single stitch with a 2-0 Vicryl can
be placed to close the incision without dif fi culty. Because a dilating (nonbladed)
trocar is used to stretch the incision, the incision quickly collapses to a smaller diam-
eter after removal of the trocar. The 5-mm trocar is removed and the skin closed with
a 4-0 monocryl suture. The patient is extubated and taken to the recovery room.
Postoperative Care
All patients are kept in the hospital overnight. The clinical protocol follow-up evalu-
ation includes daily phone calls from the surgeon to check the temperature and pain
levels postoperatively and clinic visits at 1 week and 1 month. No additional labora-
tory or radiographic testing is performed.
Results
NOTES cholecystectomy can be performed safely as shown by many clinical series
from all over the world. A recent review of the published clinical NOTES cases by
Auyang et al. [ 26 ] selected a total of 432 NOTES cases, with a majority (84 %)
transvaginal procedures, followed by transgastric (13 %), transesophageal (4 %),
and transrectal (0.5 %). Of all reported NOTES cases, 90 % were performed in
hybrid fashion with transabdominal laparoscopic assistance. Cholecystectomy was
the predominant procedure, accounting for 84 % of cases. The largest overall sin-
gle-center experience consisted of 128 hybrid transvaginal cholecystectomies by
Federlein et al. [ 27 ] in Germany, reported in 2010.
212
S.F. Majid et al.
Compared with other natural ori fi ce access routes, the transvaginal approach to
NOTES imparts the least amount of risk to the patient. However, this approach is
controversial given its sensitive and private nature. Numerous vaginal and trans-
vaginal gynecologic procedures are performed daily across the United States.
Furthermore, data have shown this approach to be safe and effective. It contrasts
heavily with the transgastric approach, in which intentional perforation of the gas-
tric wall is a novel concept.
One of the largest published series of 100 laparoscopic and combined culdo-
scopic procedures (hybrid NOTES) using multiple transabdominal instruments
resulted only in a single uncomplicated postoperative fever [
28 ] . Additionally, series
comparing laparoscopically assisted vaginal hysterectomy with laparoscopic hys-
terectomy have found similar complication rates despite the use of the vaginal con-
duit [ 29, 30 ] . Published studies have demonstrated a higher incidence of certain
complications (bladder injury, blood loss greater than 1 l, and vaginal hematoma)
using a vaginal approach [ 31 ] . It also should be noted that the incision in a NOTES
transvaginal procedure and the blood loss with this procedure are less than seen
with vaginal hysterectomy. It could be surmised that the addition of laparoscopic
vision used in a NOTES approach should reduce the likelihood of bladder injury or
excess bleeding.
In recent years, vaginal hysterectomy has gained momentum in many countries
as the operation of choice for benign uterine disease requiring an operation [ 32 ] .
The route of hysterectomy appears to have little effect on postoperative sexual func-
tion [ 33 ] . Overall pain scores are improved by a vaginal approach compared with
abdominal hysterectomy [ 34, 35 ] . This probably is due to the avoidance of an inci-
sion in the abdominal wall musculature. This bene fi t also extends to NOTES.
Clearly, it is critical to discuss all the potential known and unknown risks of a
transvaginal NOTES procedure in obtaining informed consent. The risk of infertil-
ity after transvaginal NOTES procedures is unknown, but avoidance of bleeding and
in fl ammation to the pelvis should minimize this potential risk. Although the mere
suggestion that this procedure could lead to infertility may discourage many propo-
nents of NOTES, the experience of reproductive medicine suggests that the risk is
likely to be very small. The transvaginal approach is sometimes used for the deliv-
ery of therapy to women with refractory infertility [ 32, 36, 37 ] , and transvaginal
procurement of oocytes has been in practice for more than 20 years [ 38 ] .
A survey conducted at our institution found that approximately 68 % of women
( N = 100) would be willing to undergo a transvaginal procedure for gallbladder dis-
ease if the complication rate were similar. This is consistent with surveys regarding
patient attitudes toward NOTES at other institutions [
39 ] .
Patients do not require the oral narcotic medications typically given after these
procedures. This may be due in part to sparing of the muscle fi bers of the abdominal
wall. Placement of the transumbilical trocar also spares these fi bers and makes use
of an existing scar. Still, it is impossible to compare pain outcomes without a further
prospective study comparing natural ori fi ce surgery with laparoscopic surgery.
213
16 NOTES: Cholecystectomy (U.S. Experience)
At the follow-up visit, no complications were reported by any of the patients.
The patients were advised to observe pelvic rest for 4 weeks postoperatively. All
sexually active patients reported a return to normal sexual activity. A summary of
our previously published results of the fi rst 11 human NOTES cases performed at
UCSD is in Table 16.1 .
Larger studies are needed to determine the true safety and ef fi cacy of the trans-
vaginal approach. A national database is the best means for collecting data on the
natural ori fi ce experience.
Technique Using the Incisionless Operating Platform
This section describes our technique using the incisionless operating platform (IOP)
(USGI Medical, San Clemente, CA) (Fig. 16.4 ).
Table 16.1 Data from the fi rst 11 NOTES cases performed by Horgan and colleagues
Patient Operation Age (years)
Time
(min)
Abdominal
trocars Hospital stay Complications
1 Transvaginal
cholecystectomy
19 150 2 1 night None
2 Transvaginal
cholecystectomy
22 96 2 1 night None
3 Transvaginal
cholecystectomy
26 70 1 1 night None
4 Transvaginal
cholecystectomy
39 92 1 1 night None
5 Transvaginal
cholecystectomy
49 93 1 1 night None
6 Transvaginal
cholecystectomy
42 114 1 1 night None
7 Transvaginal
cholecystectomy
35 165 1 1 night None
8 Transvaginal
cholecystectomy
33 140 1 1 night None
9 Transvaginal
cholecystectomy
47 110 1 1 night None
10 Transvaginal
appendectomy
42 150 One plus
two
2-mm
ports
1 night None
11 Transvaginal
appendectomy
24 78 1 1 night None
Source : With kind permission of Springer Science+Business Media. Reprinted with permission
from Horgan et al. [
40 ]
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