Original Clinical Science

Surgical Innovation
2020, Vol. 0(0) 1–8
Natural Orifice Transluminal Endoscopic © The Author(s) 2020
Article reuse guidelines:
Surgery: Long-Term Experience with sagepub.com/journals-permissions
DOI: 10.1177/1553350620932402

Hybrid Transvaginal Cholecystectomies journals.sagepub.com/home/sri

Fabian Rössler, MD1,2, Andreas Keerl, MD1,

Uwe Bieri, MD1,3, Juliette Slieker, MD, PhD1,
and Antonio Nocito, MD1

Abstract
Objective. To assess outcome and safety of 571 hybrid natural orifice transluminal endoscopic surgery (NOTES)
cholecystectomies. Methods. We retrospectively analyzed all consecutive NOTES cholecystectomies performed at our
center between June 2009 and January 2018. All procedures were performed using a hybrid transvaginal technique,
including an umbilical small-size trocar. End points, calculated at discharge, 30 and up to 90 days postoperatively, included
intra- and postoperative morbidity assessed by the validated Clavien–Dindo classification and the Comprehensive
Complication Index (CCI). Special focus was held on outcome and necessity of pre- and postoperative gynecological
examinations. Results. We performed 571 hybrid NOTES cholecystectomies within 9 years. The vast majority were
elective, 9.6% were emergency cholecystectomies. 6.7% of patients developed at least one complication until discharge,
most of them minor (≤grade II). 30- and 90-day complication rates were 10.7% and 11%, respectively. Mean CCI at
discharge and postoperative days 30 and 90 was 1.45 (±6.4), 2.3 (±7.7), and 2.4 (±7.8), respectively. Major complications
(≥grade IIIa) occurred in 1.6% of patients, and 4 patients required emergency reoperation. No mortality was observed. In
9.8%, an additional abdominal trocar was placed. All patients underwent routine gynecological examination, whereof only
5 were rejected for transvaginal access preoperatively. In no case transvaginal access was discontinued intraoperatively
due to gynecological disease. Conclusion. Hybrid NOTES transvaginal cholecystectomy represents a safe and feasible
alternative to standard laparoscopic cholecystectomy. Preoperative gynecological examination is no longer routinely
necessary, as intraoperative assessment is adequate.

Keywords
natural orifice transluminal endoscopic surgery, transvaginal, cholecystectomy, minimal invasive surgery

Introduction
Minimal invasive surgery is nowadays standard in many
fields of surgery, especially for cholecystectomy. It is
associated with less pain, a shorter hospital stay, and
fewer complications than open surgery.1-3 Natural orifice
transluminal endoscopic surgery (NOTES) represents an
evolution of laparoscopic surgery, pursuing even less
invasiveness and scarring. It has the potential to eliminate
related complications, such as incisional hernias, and
obtain better cosmetic outcomes, lowering postoperative
pain, and shorten recovery time.4,5
First reports of NOTES cholecystectomies in humans
were published in 2007.6-8 What followed was a rising
interest resulting in an increase in clinical applications and
trials.
In recent years, several reports showed promising
results for the transvaginal approach of cholecystectomy,
with similar postoperative complications and mortality
rates, but less pain and higher cosmetic satisfaction,9-13
even in a randomized comparison to a three-trocar cho-
lecystectomy.14 In addition, studies showed no significant
difference in safety of NOTES compared to standard
laparoscopic cholecystectomy.9,15-17
Even though feasibility and safety of hybrid NOTES
transvaginal cholecystectomy (TVC) are proven, expert
opinions differed widely on NOTES, and its implemen-
tation was controversially discussed over the last years.
Critics were encouraged by the fact that the use was
1
Department for General, Visceral and Vascular Surgery, Kantonsspital
Baden, Switzerland
2
Department of Surgery and Transplantation, University Hospital
Zurich, Switzerland
3
Department of Urology, University Hospital Zurich, Switzerland
Corresponding Author:
Fabian Rössler, MD, University Hospital Zurich, Rämistrasse 100,
Zurich 8091, Switzerland.
Email: fabian.roessler@usz.ch
2 Surgical Innovation 0(0)
limited to a few highly specialized centers, concerning
restrictions in training, higher costs, and extended oper-
ation time.18 However, initial concerns on impaired post-
operative sexual function or menstrual changes16,17,19
were not confirmed.
In recent years, interest on NOTES decreased, which
is reflected by a decline of publications and audience.
However, our department is a high-volume center for
NOTES, and after its introduction in our clinic in 2009, it
became our standard surgical technique for cholecystec-
tomy during many years. Safety and patient satisfaction
were promising, and we further successfully implemented
hybrid transvaginal techniques for appendectomies and
intraperitoneal hernia repair.20,21 The aim of our study was
to assess outcome and complications of NOTES TVC, with
a focus on evaluating necessity and consequences of pre-
and postoperative routine gynecological examinations.
Methods
Patients and Study Design
In this retrospective cohort analysis, we reviewed medical
records of all patients who underwent a hybrid NOTES
TVC at the Kantonsspital Baden, Switzerland, between
June 2009 and January 2018. Within this study period,
571 TVCs were performed. June 2009 represents the start
of routinely performed TVC at our institution. During that
period, we routinely proposed the transvaginal approach
to all patients with an indication for cholecystectomy.
Patients refusing TVC were operated through standard
laparoscopy. The exclusion criteria for TVC were defined
as follows: pregnancy, peritoneal dialysis, current ma-
lignant gynecologic disease, and pelvic inflammatory
disease. The transvaginal approach was also proposed to
patients with need for emergent cholecystectomies but,
then, depending on the degree of experience with TVC of
the on-call surgeon. Informed consent was obtained from
all patients prior to their NOTES procedure. Appropriate
ethical approval from the institutional ethical board of
Northwest and Central Switzerland was obtained before
analysis and publication of data.
Surgical Procedure
In all operated patients, results of a recent routine gyne-
cological examination had to be available. All procedures
were performed using a hybrid transvaginal technique,
with an abdominal (umbilical) small-size (5 mm) trocar. A
500-mg metronidazol ovulum was inserted the evening
prior to surgery, and 1.5 g cefuroxime (Zinacef, Glaxo-
SmithKline, London, United Kingdom) was given in-
travenously around 30 minutes prior to skin incision. In the
operating room, patients were placed in modified lithot-
omy position, and a single-use catheter was used to empty
the urinary bladder. The operating surgeon sits between the
spread legs of the patient, and the assistant stands to the left
of the patient. Capnoperitoneum was established using a
Veress needle through the umbilicus to minimize incision
scars. The access was then dilated with a 5-mm VersaStep
(Covidien, Dublin, Ireland), and diagnostic laparoscopy
was performed using a 5-mm 30 laparoscope. In Tren-
delenburg position, transvaginal trocars were inserted
under laparoscopic view (12- and 5-mm VersaStep Plus,
Covidien, Dublin, Ireland) through a posterior colpotomy
into the Douglas pouch. Cholecystectomy was performed
using a laparoscopic clamp for retraction and a monopolar
hook for dissection inserted via the 2 transvaginal trocars.
The laparoscope was kept transabdominally. The critical
view of safety was presented in the same way as for
laparoscopic cholecystectomy. Closure of the cystic duct
was performed with Hem-o-lok clips (Weck Closure
Systems, Research Triangle Park, North Carolina, USA).
After transvaginal removal of the gallbladder, the 12-mm
transvaginal access was closed with absorbable sutures
(coated Vicryl 2-0. Ethicon, Somerville, New Jersey,
USA), and the 5-mm umbilical access was closed with
skin sutures. All patients were seen in our outpatient
clinic 4–6 weeks after surgery and received an outpatient
gynecological control.
Patient characteristics including age, sex, comorbid-
ities, body mass index (BMI), Charlson Index, American
Society of Anesthesiologists (ASA) score, smoking, pre-
vious abdominal and gynecological surgeries, pre- and
postoperative gynecological examination, length of hos-
pitalization, and indication for surgery, as well as in-
formation on readmission were collected. Characteristics
of surgery included the following variables: duration of
operation, need for additional abdominal trocars, trans-
fusion, and any “atypical” intraoperative events.
We assessed morbidity intraoperatively, at discharge,
as well as 30- and 90-days after surgery according to
the validated Clavien–Dindo grading system22,23 and the
CCI, measuring overall morbidity from zero (uneventful)
to 100 (death).24,25 The CCI was established in a retro-
spective manner. To assess the incidence and risk factors of
gynecological complications, all data on preoperative and
postoperative gynecological examinations were analyzed.
Statistical Analysis
Statistical analysis was performed with Statistical Package
for the Social Science from International Business Ma-
chines, version 25. The output of the descriptive analysis
displays data of continuous variables as mean with stan-
dard deviation and range. Binary and categorical variables
are expressed as counts and percentages. Analysis of
variance was performed using the Mann-Whitney U test
and the Kruskal-Wallis test for comparison between 2
independent groups and between more than 2 independent
Rössler et al 3

Table 1. Patient Characteristics. surgery, 42.7% had previous gynecological surgery, and
18.9% have had hysterectomy. Most surgeries were
Age (years) 50.7 ± 14.8
elective (n = 516, 90.4%), emergency cholecystectomy
BMI (kg/cm2) 27.8 ± 5.9
was performed in 9.6%. Surgical indications are listed in
ASA score (%)
≤I 24.2
Table 2. The mean operation time was 64 (±25) minutes.
≥ II 75.8 The mean hospital stay was 2.56 (±3.3) days, ranging
Charlson index (%) from 1 to 54 days.
≤0 86.7
≥1 13.3 Intraoperative Complications
Smokers (%)
Intraoperative complications occurred in 18 patients
Yes 21.5
(3.2%). Most complications (n = 6, 33.3%) were small
No 78.5
Previous abdominal surgery (%) 48.5
gynecological lesions that were repaired immediately.
Previous gynecological surgery (%) 42.7 Four patients had urinary bladder lesions requiring su-
turing and catheter placement, with no long-term com-
Abbreviations: BMI = body mass index; ASA = American Society of plications. One rectal lesion was sutured laparoscopically,
Anesthesiology. and the patient did not suffer from any problems after-
Continuous variables are expressed as mean ± standard deviation.
Categorical variables are expressed in percentages. ward. The remaining intraoperative complications were 3
small uterine injuries, 2 lesions of the cystic duct, 1 su-
perficial intestinal lesion, 1 perforation of a simple ovarian
Table 2. Surgery-Related Characteristics. cyst, and 1 bleeding from the intestinal mesentery. All
complications were resolved during surgery and led to no
Operation time (minutes) 64 ± 25
Hospital stay (days) 2.56 ± 3.3
further problems.
Indications for surgery (%)
Symptomatic cholecystolithiasis 61.3 Conversion
Chronic cholecystitis 11.4
Previous acute cholecystitis 8.4 Additional abdominal trocars (5 mm trocars) were placed
Acute cholecystitis 6.5 in totally 56 patients (9.8%) and were mostly used for
Previous ERCP for choledocholithiasis 6.3 better exposition in cases with adhesions, extended in-
Lithogen pancreatitis 5.9 flammation, or when additional surgical interventions,
Gallbladder polyp 0.2 mostly gynecological, were performed. A mean of 1.1
Abdominal trocars (%) (±0.37) transabdominal trocars was needed. Intraopera-
≤1 91.2 tive conversion rate was low, with only 2 patients needing
>1 9.8 surgical extension. In 1 patient, conversion to laparoscopic
Abbreviation: ERCP = endoscopic retrograde cholangio-
cholecystectomy was needed to exclude small bowel in-
pancreaticography. jury. Cholecystectomy was performed laparoscopically, but
Continuous variables are expressed as mean ± standard deviation. gallbladder extraction was still performed transvaginally.
Categorical variables are expressed in percentages. One patient needed conversion to laparotomy due to
massive inflammation and difficulties in exposure of the
groups, respectively. The level of significance was set at cystic duct.
0.05 (two-sided) for each statistical test.
Postoperative Complications
Results Postoperative complications, CCI, and readmission rates
are listed in Table 3. Overall, the complication rate at
Patient Characteristics discharge and 30 and 90 days postoperatively was 6.7%
Within the study period, 571 TVCs were performed and (n = 38), 10.7% (n = 61), and 11% (n = 63), respectively.
included in this analysis. The mean CCI at discharge and postoperative days 30 and
Patient and surgical-related characteristics are listed in 90 was 1.45 (±6.4), 2.3 (±7.7), and 2.4 (±7.8), respectively
Tables 1 and 2. (range 0 to 60.1).
The mean age at surgery was 50.7 (±14.8) years, Overall, 63 (11%) patients developed 79 complications
ranging from 17 to 86 years and a mean BMI of 27.8 within 90 days after surgery. Most of the patients (n = 51)
(±5.9). Most patients had an ASA score ≥ II 2 (75.8%), developed only one complication within 90 days. Eight
with a Charlson Index of 0 in 86.7%. Of all patients, patients (1.4%) developed 2 complications, and 4 patients
21.5% were smokers, 48.5% had previous abdominal (0.7%) developed 3 or more complications within 90 days.
4 Surgical Innovation 0(0)

Table 3. Postoperative Complications.

At Discharge After 30 Days After 90 Days

Any complication 6.7% (n = 38) 10.7% (n = 61) 11% (n = 63)

Major complications (≥IIIa) 1.6% (n = 9) 3% (n = 17) 3.3% (n = 19)
Minor complications (≤II) 5.1% (n = 29) 7.7% (n = 44) 7.7% (n = 44)
CCI 1.45 (±6.4) 2.3 (±7.7) 2.4 (±7.8)
CCI only minor complications 16.4 (±7.1) 16 (±6.8) 16 (±6.8)
CCI only major complications 39.3 (±11.6) 35.6 (±10.9) 35 (±10.5)
Readmission rate 3.5% (n = 20)
Mortality 0 0 0

Abbreviation: CCI = comprehensive complication index.

Continuous variables are expressed as mean ± standard deviation. Categorical variables are expressed in percentages.

All patients who suffered from more than one compli- ultrasound-guided drainage of a hematoma in the gall-
cation had major complications (≥grade IIIa). Between bladder bed 21 days after surgery. Other readmissions
30 and 90 days after surgery, only 2 patients developed were due to gynecologic or urologic infections with need
a complication, both of them major. for intravenous antibiotics.
Incidence and severity of the most common compli-
cations are listed in Table 4. There was no significant
relation between emergency operations for acute chole- Gynecological Control
cystitis, prior abdominal, or gynecological surgeries and
All patients underwent routine gynecological examination
postoperative complications. Furthermore, we did not
before surgery. In 110 patients (19.3%), an abnormality
observe higher rates of complications or more severe
was found preoperatively, mostly cysts (4.9%), myomas
complications in the first one hundred operations.
(4.2%), or local infections that required antibiotic or
Bile duct lesions, independent of the grade of the
antifungal treatment (3.2%) only. In 11 patients (1.9%),
complication, occurred in 4 patients (0.7%). All of them
a postmenopausal hyperplastic endometrium was seen,
were treated successfully by endoscopic retrograde
and diagnostic curettage was then performed additionally
cholangio-pancreaticography (ERCP) and stenting. One
to cholecystectomy during the same intervention. Be-
patient needed an additional reoperation and lavage for
tween 2011 and 2018, only 5 patients out of 411 were
biliary peritonitis, with severe pain, and 2 needed sur-
rejected for transvaginal surgery due to gynecological
veillance at the intensive care unit. All lesions were minor
disease detected during preoperative gynecological ex-
due to leakage of the cystic stump or from accessory bile
amination. This led to a number needed to screen of 83.2
ducts. None of the lesions were made during emergency
to refuse 1 patient from transvaginal surgery. The average
operations or for severe acute cholecystitis.
cost for a routine preoperative gynecological examination
Regarding major complications (≥IIIa Clavien–Dindo
was 205 Swiss Francs (corresponding to 211 US dollars).
grading), grade IIIb complications occurred in 5 patients
Reasons to refuse transvaginal access were local infection
(0.9%). Three patients needed reoperation for bleeding,
(n = 1), a complex adnex cyst (n = 1), an intrauterine
one with laparotomy. One patient was reoperated for
tumor (n = 1), a previous complex perivaginal mesh repair
biliary peritonitis and another for ileus due to adhesions
(n = 1), and virginity (n = 1). All of those patients un-
2 months after cholecystectomy. Two patients suffered
derwent standard laparoscopic cholecystectomy after-
grade IV complications with need for intensive care
ward. In 1.1% (n = 6) of patients, a gynecological
treatment due to cardiac decompensation. There was no
abnormality was found intraoperatively that was not
grade V complication until discharge, readmission, or
known before surgery. In none of these 6 cases it was
within the first 90 days after cholecystectomy.
a contraindication to surgery, and the intervention was
performed as planned.
Readmission Rate Almost all patients (n = 523, 91.6%) underwent routine
Readmission rate within 90 days was 3.5% (n = 20). The gynecological examination between 4 and 6 weeks after
mean readmission time was 13.4 (±13) days after initial surgery. The rest of the patients (n = 48, 8.4%) refused
discharge. The mean length of hospitalization after re- checkup due to lack of symptoms or did not show up for
admission was 4.8 (±3) days. Most readmissions were due control. Of those controlled, 5.1% had minor gyneco-
to choledocholithiasis or biliary pancreatitis (n = 9). logical abnormalities, mostly local infections (n = 44,
One patient underwent relaparoscopy for adhe- 4.2%). No severe gynecological problems have been
sion ileus 73 days after surgery. One patient received observed.
 Rössler et al

Table 4. Incidence of the Most Common Complications Within 90 Days by Diagnosis and Severity.

Grade of Total

% of all Complications
ERCP for Choledocholithiasis
ERCP for Bile Leakage
Cardiopulmonary
Intraabdominal Collection
Abdominal Bleeding/Hematoma
Urinary Retention
UTI
Blood Transfusion
Vaginal Hemorrhage/Pruritus
Electrolyte Disorders
Ileus
Unclear Pain
Neurologic
Antibiotics for Infection, Other
PONV

Complication (n)

I 20 25.3 2 (0.35) 3 (0.53) 7 (1.23) 3 (0.53) 2 (0.35) 2 (0.35) 1 (0.18)

II 37 46.9 3 (0.53) 9 (1.58) 10 (1.75) 3 (0.53) 10 (1.75) 2 (0.35)
IIIa 15 19 8 (1.4) 4 (0.7) 3 (0.53)
IIIb 5 6.3 1 (0.18) 3 (0.53) 1 (0.18)
IVa 2 2.5 2 (0.35)
IVb 0 0
V 0 0

Abbreviations: ERCP = endoscopic retrograde cholangio-pancreaticography; UTI = urinary tract infection; EC = erythrocyte concentrate; PONV = postoperative nausea and vomiting.
Numbers in () are expressed in percentages.
5
6 Surgical Innovation 0(0)
Discussion
This study analyzes the largest patient collective on
NOTES transvaginal cholecystectomies published so
far. It is the first study to examine the role of standard
preoperative gynecological examination prior to trans-
vaginal surgery, with a special regard on complications
and gynecological problems. Our high-volume data
confirm safety and feasibility of hybrid NOTES TVC. As
a new insight, we prove that routine preoperative gy-
necological examination is not necessary due to lack of
significant implication on outcome and technical ap-
plications of transvaginal NOTES. These results led to
a change in our daily practice, and gynecological as-
sessment is now reserved for high-risk or symptomatic
patients only.
In contrast to other studies, we recorded all compli-
cations within the first 90 days, using not only the well-
established Clavien-Dindo complication grading22,23 but
also the CCI.24,25 The CCI is known to provide optimum
information on the cumulative morbidity since assessment
of peri- and postoperative events alone is not adequate to
cover a significant statement on the outcome of a surgical
technique.26-29
In literature, low complication rates, less postoperative
pain, and superior cosmetic results in comparison to
standard laparoscopic cholecystectomy have been de-
scribed. Our overall morbidity rate was low and consistent
with that of previous analyses.11,20,30 Most postoperative
complications were minor and occurred within the first
30 days after surgery. This applies as well for readmission
rates. Most of readmissions were due to choledocholithiasis
or biliary pancreatitis, therefore not related to the trans-
vaginal access. Our mean length of hospital stay was
2.56 days, thus consistent with other centers that perform
NOTES.10,15 According to our experience and the current
literature, the length of hospitalization after NOTES cho-
lecystectomies does not significantly differ from laparo-
scopic cholecystectomies.9,10,31 However, one needs to
consider national variations in discharge policies.
Interestingly, conversion rate to laparoscopy was lower
than previously reported,11,30 and only 1 patient (0.18%)
was converted to laparotomy due to massive inflamma-
tion and difficulties in decent exposure of the cystic duct.
An additional abdominal trocar was needed in 9.8% of
patients.
The incidence of bile duct lesions (0.7%) was slightly
higher than recently reported for laparoscopic cholecys-
tectomies.32-34 Reasons therefore could relate to a higher
learning curve for NOTES and the broad variety of
surgeons performing NOTES with different levels of
experience. Those bile duct lesions happened during
elective surgeries only, without severely inflamed gall-
bladders, and all of them were treated successfully by
ERCP and stenting.
Access-related complications were mostly minor and
either solved immediately or by additional placement of
abdominal trocars. In no event, transvaginal access needed
to be interrupted intraoperatively. Furthermore, about 50%
of patients had prior abdominal and about 40% prior gy-
necological surgeries, suggesting a risk of intraabdominal
adhesions and a higher risk for access-related complica-
tions. However, we did not find any significant relation
between prior abdominal or gynecological surgeries and
postoperative complication rate. This proves as well safety
and feasibility of transvaginal access in patients with prior
surgeries. Furthermore, this demonstrates that our pre-
operative screening for patients suitable for TVC was not
too selective.
Particular attention was paid to the analysis of the
routine gynecological examination. Up to now, all of our
patients underwent standard preoperative gynecological
examination prior to TVC. During the study period, only 5
patients were rejected for transvaginal surgery due to
gynecological disease detected during this preoperative
gynecological examination. In addition, postoperative
gynecological problems discovered during the routine
postoperative control were as well mostly minor or even
irrelevant. This is why we believe that gynecological
examination is not needed routinely anymore before
and after TVC and should be reserved for high-risk or
symptomatic patients only. According to those results, we
changed our practice, and we do not use routine pre-
operative gynecological examinations anymore. By per-
forming a transvaginal access, every patient automatically
receives a vaginal examination, and if then suspicious
lesions are found, gynecological support can be requested
immediately. Moreover, if necessary, the procedure can be
easily converted to laparoscopy.
Although we believe to confirm safety and feasibility
of TVC and offer new insights on the value of routine
gynecological examinations, there are some limitations
of our study. First, it is a retrospective analysis with its
known limitations of data collection and missing data.
Second, the current study does suffer from the lack of
randomization of its patients and a comparison to a lap-
aroscopic surgery group. In addition, due to the small
amount of emergency operations, only limited conclusion
can be drawn for hybrid cholecystectomies in the emer-
gency setting.
In conclusion, with low rates for overall morbidity and
conversion to open surgery, we confirm safety and fea-
sibility of TVC. Considering the known benefits on
postoperative pain and cosmetics, this study emphasizes
its value as a valid surgical alternative to laparoscopic
cholecystectomy. Routinely performed pre- and post-
operative gynecological examination is no longer nec-
essary, as intraoperative assessment is adequate. Detailed
pre- and postoperative gynecological assessment should
be reserved for high-risk or symptomatic patients only.
Rössler et al
Author Contributions
Study concept and design: Fabian Rössler, and Antonio Nocito
Acquisition of data: Fabian Rössler
Analysis and interpretation: Fabian Rössler, Andreas Keerl, Uwe
Bieri, Juliette Slieker, and Antonio Nocito
Study supervision: Antonio Nocito
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship, and/or publication of this
article.
Funding
The author(s) received no financial support for the research,
authorship, and/or publication of this article.
ORCID iDs
Fabian Rössler  https://orcid.org/0000-0002-2968-347X
Uwe Bieri  https://orcid.org/0000-0002-7339-1458
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