JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES

Volume 21, Number 1, 2011 Full Reports

Mary Ann Liebert, Inc.
DOI: 10.1089/lap.2010.0255

Laparoscopic Cholecystectomy in Cirrhotics:

A Prospective Randomized Study Comparing
the Conventional Diathermy and the Harmonic
Scalpel for Gallbladder Dissection
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Samer S. Bessa, MD, Alaa H. Abdel-Razek, MD, Mohamed A. Sharaan, MD,

Ahmed E. Bassiouni, MD, Mahmoud A. El-Khishen, MD, and El-Saed A. El-Kayal, MD

Abstract

Background: Ultrasonically activated devices have been used for gallbladder dissection in laparoscopic chole-
cystectomy (LC) with encouraging results. The aim of the present study was to compare the surgical outcome of
LC performed by the harmonic shears to that performed by the conventional diathermy in patients with cirrhosis.
Methods: In this prospective randomized study, 40 cirrhotic Child-Pughs classes A and B patients with
symptomatic uncomplicated gallstones disease were randomly assigned to either the Harmonic scalpel LC
group (20 patients) or the conventional diathermy LC group (20 patients).
Results: The use of the harmonic shears was associated with a statistically significant shorter median operative
time (55 vs. 82.5 minutes, P .000), less median estimated intraoperative blood loss (50 vs. 120 mL, P .000), and
lower incidence of gallbladder perforation (10% vs. 70%, P .000). In the Harmonic scalpel LC group, La-
paroscopic subtotal cholecystectomy was resorted to in eight patients (40%) compared with six patients (30%) in
the conventional diathermy LC group. No statistically significant difference was found between both groups as
regards the conversion rate, the median hospital stay, and the incidence of postoperative complications. Neither
bile leaks nor Bile duct injuries were encountered in either group. Similarly, no mortalities were encountered in
the present study.
Conclusions: The Harmonic shears achieved complete hemobiliary stasis. Further, it provided a superior al-
ternative to the conventional diathermy in terms of shorter operative time, less intraoperative blood loss, and
lower incidence of gallbladder perforation partly through facilitating the performance of laparoscopic subtotal
cholecystectomy.

Introduction loss, shorter operative time, and shorter length of hospitali-

zation in patients with cirrhosis.48

C holelithiasis in patients with cirrhosis occurs twice as

often as in the general population with reported rates of
9.5%13.7% versus 5.2% in patients without cirrhosis.1 A re-
view of *4895 autopsy records in the literature showed that
the frequency of cholelithiasis was 29.4% in patients with
cirrhosis, whereas it was 12.8% in patients without cirrhosis.2
The morbidity and mortality rates for open cholecystectomy
in patients with cirrhosis were reported to be as high as 17%
27%.3 Such poor results were mainly due to either excessive
blood loss with subsequent postoperative liver failure and/or
sepsis.3 Laparoscopic cholecystectomy (LC), on the other
hand, has been shown to offer the advantages of less blood
Standard LC is commonly performed by means of special-
ized instruments. For gallbladder dissection, the electrosurgical
hook, spatula and/or scissors using high frequency monopolar
technology have been used in most centers. Occlusion by
simple metal clips was the most frequently used technique to
achieve both cystic duct and artery closure. Several studies
have described the use of ultrasonic technology in LC, where
the harmonic shears were used as the sole instrument (apart
from the camera and retraction forceps) to achieve both dis-
section of the gallbladder and closure/division of the cystic
duct and artery.913 These studies demonstrated that the har-
monic shears provided a superior alternative to the currently

Department of General Surgery, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.

1
 2 BESSA ET AL.
used high-frequency monopolar technology in terms of shorter
operative time and lower incidence of gallbladder perfora-
tion.9,1214 Further, the harmonic shears were as safe and ef-
fective as the commonly used metallic clips in achieving safe
closure and division of the cystic duct in LC.914 The above-
mentioned advantages may prove beneficial in patients with
cirrhosis undergoing LC. The aim of the present prospective
randomized study was to compare the surgical outcome of LC
performed by the harmonic shears to that performed by the
conventional diathermy in patients with cirrhosis.
Patients and Methods
The study was approved by the Ethics Committee of the
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Faculty of Medicine of the University of Alexandria. An in-
formed consent was obtained from all patients included in the
study. Inclusion criteria included patients with Child-Pughs
classes A and B and with symptomatic uncomplicated gall-
stones disease. Patients with Child-Pughs class C were ex-
cluded. Other exclusion criteria included acute cholecystitis,
patients with common bile duct stones, suspicion of gall-
bladder malignancy based on ultrasonography, and subse-
quent computed tomography findings. No intraoperative
cholangiograms were performed. Patients presenting with
associated abnormal alkaline phosphatase and gamma-
glutamiltransferase levels and/or abnormal ultrasonographic
findings (e.g., dilated common bile duct >8 mm) underwent
an endoscopic retrograde cholangiopancreatography (ERCP).
Associated common bile duct stones were treated by sphinc-
terotomy and stone extraction. Failure to extract common bile
duct stones preoperatively was considered an exclusion cri-
terion. The diagnosis of cirrhosis was determined according to
clinical history, laboratory data, findings on ultrasonography,
and the presence of varices on upper gastrointestinal endos-
copy and was confirmed by liver biopsy.
The following preoperative data were collected: age, sex,
Child-Pugh classification, associated co-morbidities, and his-
tory of previous lower abdominal surgery. After preoperative
evaluation and preparation for surgery, patients were ran-
domly assigned using the sealed envelope technique to either
the Harmonic scalpel LC group (HSLC group) in which the
Harmonic ACE (Ethicon Endo-Surgery, Cincinnati, OH)
was the only instrument used for both dissection and closure/
division of cystic duct and artery or the conventional dia-
thermy LC group (CDLC group)
Operative procedures were performed with the patient
under general anesthesia and placed in the standard supine,
crucifix, and reverse-Trendelenburg position with the right
shoulder up. A uniform technique of LC was applied, in-
cluding the use of the standard four trocar technique; a
pneumoperitoneum was created using carbon dioxide with a
maximized pressure of 15 mmHg and a 08 optical scope. In
patients in whom laparoscopic subtotal cholecystectomy
(LSC) was performed, the Palanivelu et al. classification was
used to define the variant of LSC performed (LSC I; LSC was
performed by leaving the posterior wall intact with the liver
and the remnant mucosa was electrofulgrated. LSC II; the
infundibulum was divided circumferentially as close to the
junction of the gallbladder and cystic duct as safely possible,
the mucosa in the proximal remnant was electrofulgrated and
the flap was sutured with continuous suture of polygalactin
30. LSC III; this is a combination of LSC I and LSC II).15
Open laparoscopy at the umbilical port site was performed
in all patients. In patients with evident collateral circulation
around the umbilicus (Caput medusae), the periumbilical
area was avoided to prevent injury of the umbilical vein.
Other ports were placed by prior transillumination of the
abdominal wall through the scope of the umbilical port. The
sub-xiphoid port was placed more to the right of the midline
to avoid the Falciform ligament and its accompanying um-
bilical vein. Dissection of the gallbladder was initiated at the
triangle of Calot with identification and skeletonization of
both cystic duct and artery. In the HSLC group, the Harmonic
ACE was used for dissection in the triangle of Calot and
closure/division of both cystic duct and artery with the power
level set at 2, which translated into less cutting and more
coagulation. In the presence of dense adhesions with sizable
collateral veins around and/or within the calot triangle where
dissection may induce bleeding that will obscure the opera-
tive field, an LSC II was performed as follows. The caudal
cystic duct-gallbladder junction was identified, and multiple
sequential applications of the Harmonic ACE at the level of
the gallbladder infundibulum as close as possible to the cystic
duct-gallbladder junction were applied to achieve complete
division/closure of the gallbladder from both the cystic duct
and artery. In the CDLC group, dissection of the triangle of
Calot was performed with an atraumatic dissecting forceps.
Closure of the cystic duct and artery was achieved by ap-
plying simple titanium clips, whereas division of both struc-
tures was achieved by scissors in the usual manner. Dissection
of the gallbladder from the liver bed started posteriorly at the
triangle of Calot and proceeded anteriorly. In the HSLC
group, the peritoneum covering the gall bladder was incised
using the active blade of the Harmonic ACE starting poster-
iorly and proceeding anteriorly on both sides of the gall
bladder. Next, the jaws of the Harmonic ACE were closed
over a bite of the tissues in the plane of dissection. Finally, the
harmonic shears were activated to achieve both cutting and
coagulation of the tissues grasped between the jaws of the
Harmonic ACE. This process was repeated until the gall
bladder was completely dissected from the liver bed. In the
case of the liver bed ooze, hemostasis was easily achieved by
applying the active blade of the Harmonic ACE tangentially
to tissue and no electrocautery was used. In the CDLC group,
dissection of the gallbladder from the liver bed was per-
formed using the electrosurgical hook or spatula in the usual
manner. In the presence of difficult dissection between the
gallbladder and its liver bed, an LSC I was performed as fol-
lows. The posterior wall of the gallbladder was not dissected
from the liver bed but rather separated from the rest of the
gallbladder and its mucosa was destroyed by electrocautery.
Every effort was made to retrieve spilled stones. Finally, the
gallbladder was removed through the sub-xiphoid port, and a
sub-hepatic tube drain was routinely placed through the most
lateral port as is our standard practice. All access ports were
checked internally just before completion of the procedure to
detect possible bleeding.
The operative time was recorded by an independent ob-
server. Intraoperative events, for example, bleeding, gall-
bladder perforation, and conversion to open cholecystectomy
were recorded. The postoperative complications and the
hospital stay were also recorded. The sub-hepatic drain was
removed on the morning of postoperative day 1, and its
wound was stitched under local anesthesia.
 CLIPLESS LAPAROSCOPIC CHOLECYSTECTOMY IN CIRRHOTICS 3

At the end of the first postoperative week, patients un- Table 1. Patients Demographics and Preoperative
derwent clinical examination and an abdominal ultrasonog- Data in Both Studied Groups
raphy with special attention to the presence or absence of any
sub-hepatic (or otherwise) fluid collections. At the end of the HSLC group CDLC group
first postoperative month, clinical examination and abdomi- (20 patients) (20 patients) P
nal ultrasonography were repeated. In addition, blood was Age: (in years)
sampled for bilirubin, aminotransferase, alkaline phospha- Range 3956 3858
tase, and gamma-glutamiltransferase levels. Median 48 48 .989
All data analysis was performed with the Statistical Pack- Gender
age for the Social Sciences version 15 software (SPSS, Chicago, Male, n (%) 12 (60%) 11 (55%)
IL). The MannWhitney U test was used for continuous var- Female, n (%) 8 (40%) 9 (45%) 1
iables. The Chi-squared and the Fishers exact test were used Etiology of cirrhosis
for categorical variables. All P values were two-sided. A Hepatitis C 7 (35%) 9 (45%) .748
P < .05 was considered statistically significant. Hepatitis B 2 (10%) 1 (5%) 1
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Hepatitis B and C 1 (5%) 0 1

Schistosmal 3 (15%) 2 (10%) 1
Results hepatic fibrosis
The present study included 40 patients. There were 23 men Mixed hepatitis (C or B) 7 (35%) 8 (40%) 1
and Schistosomal
(57.5%) and 17 women (42.5%). Their age ranged from 38 to 58
hepatic fibrosis
years with a median of 48 years. Preoperative ERCP was
Child-Pugh class
performed in three patients (7.5%) in the present study. In two
Class A, n (%) 14 (70%) 13 (65%) 1
patients (5%), associated common bile duct stones were suc- Class B, n (%) 6 (30%) 7 (35%) 1
cessfully treated for sphincterotomy and stone extraction. In
Co-morbidities
the third patient (2.5%), ERCP revealed no stones in the Diabetes mellitus, n (%) 4 (20%) 3 (15%) 1
common bile duct. After preoperative evaluation and prepa- Hypertension, n (%) 2 (10%) 1 (5%) 1
ration for surgery, patients were randomly assigned to either Previous surgery
the Harmonic scalpel LC group (HSLC group) or the CDLC Appendectomy, n (%) 2 (10%) 3 (15%) .779
group. There was no statistically significant difference be- Caesarian section, n (%) 2 (10%) 3 (15%) .779
tween both studied groups as regards age and sex distribu-
tion, etiology of cirrhosis, Child-Pugh classes, associated co- HSLC, Harmonic scalpel LC; CDLC, conventional diathermy LC.
morbidities, and previous lower abdominal surgery, as
illustrated in Table 3. Postoperative complications were en-
shown in Table 1.
countered in five patients (25%) in the HSLC group compared
Intraoperative events encountered in both studied groups
with seven patients (35%) in the CDLC group with the dif-
are illustrated in Table 2. The median estimated intraoperative
ference being statistically insignificant. Postoperative deteri-
blood loss was statistically significantly less in the HSLC
oration of liver function was the most common complication
group compared with the CDLC group (50 vs. 120 mL re-
encountered in both studied groups. All three patients (15%)
spectively, P .000). In the CDLC group, failure to control
of the CDLC group in whom the procedure was converted to
liver bed bleeding in two patients (10%) and cholecystohe-
patic triangle bleeding in another patient (5%) necessitated
conversion to open cholecystectomy in these three patients Table 2. Operative and Intraoperative Data
(15%). On the other hand, all procedures were lapar- in Both Studied Groups
oscopically completed in the HSLC group. The difference in
HSLC CDLC
the conversion rate between both studied groups was statis-
group group
tically insignificant (P .231). (20 patients) (20 patients) P
In the HSLC group, LSC II was performed in eight patients
(40%), whereas LSC I was not performed in any patient. On Estimated intraoperative blood loss
the other hand, in the CDLC group, LSC I was performed in Range 10300 50500
six patients (30%), whereas LSC II was not performed in any Median 50 120 .000a
patient. The incidence of intraoperative gallbladder perfora- Gallbladder perforation, 2 (10%) 14 (70%) .000a
tion was statistically significantly lower in the HSLC group n (%)
than in the CDLC group (10% vs. 70%, respectively, P .000). Type of LC
Intraoperative gallbladder perforation in the CDLC group Standard LC, n (%) 12 (60%) 11 (55%)
included both gallbladders inadvertently perforated during LSC I, n (%) 0 6 (30%) 1
dissection (8 patients; 40%) and those deliberately perforated LSC II, n (%) 8 (40%) 0
to perform an LSC I (6 patients; 30%). The difference was still LSC III 0 0
statistically significant when the patients in whom the gall- Operative time (in minutes)
bladder was deliberately perforated to perform a LSC were Range 4670 75120
excluded (P .028). The median operative time was statisti- Median 55 82.5 .000a
cally significantly shorter in the HSLC group than in the Conversion rate, n (%) 0 3 (15%) .231
CDLC group (55 vs. 82.5 minutes respectively, P .000) a
Statistically significant.
There were no mortalities in the present study. The post- LC, laparoscopic cholecystectomy; LSC, laparoscopic subtotal
operative complications encountered in the present study are cholecystectomy.
 4 BESSA ET AL.
Table 3. The Postoperative Complications
Encountered in Both Studied Groups
HSLC CDLC
group group
(20 patients) (20 patient) P
Wound sepsis, n (%) 1 (5%) 1 (5%) 1 significant lower incidence of gallbladder perforation, which
Chest infection, n (%) 2 (10%) 1 (5%) 1 resulted in subsequent avoidance of time loss in abdominal
Deterioration of 2 (10%) 5 (25%) .407
liver function, n (%)
Ascites, n (%) 1 (5%) 3 (15%) .605
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an open one suffered from postoperative deterioration of liver
function. The postoperative complications encountered in
both studied groups were successfully managed conserva-
tively by routine measures throughout the first postoperative
month. Neither minor nor major bile leaks were encountered
in either group. Similarly, no bile duct injuries were encoun-
tered in the present study.
The hospital stay was 2 days in the HSLC group. In the
CDLC group, it ranged from 2 to 5 days with a median of 2
days. The difference in the median hospital stay between both
studied groups was statistically insignificant (P .075).
Discussion
The main finding of the present study is that the use of the
Harmonic ACE in LC in patients with cirrhosis is associated
with a statistically significant shorter median operative time,
less median intraoperative blood loss, and lower incidence of
intraoperative gallbladder perforation, compared with the
use of the conventional diathermy.
El-Nakeeb et al., in the only prospective randomized study
comparing clipless LC using the harmonic shears to the tra-
ditional LC using the clip and cautery technique in patients
with cirrhosis, confirmed the safety and efficacy of the har-
monic shears in achieving complete hemobiliary stasis.14 The
findings of the present study are in total agreement with this
conclusion. In the present study, the absence of either minor
or major bile leaks add further confirmation to the safety and
efficacy of the harmonic shears in achieving complete hemo-
biliary stasis in patients with cirrhosis undergoing LC. Fur-
ther, in El-Nakeeb et al. study as well as the present study, the
use of the harmonic shears has been shown to be associated
with a statistically significant shorter mean/median operative
time, less mean/median intraoperative blood loss, and lower
incidence of gallbladder perforation.14
Earlier studies have demonstrated that the use of the har-
monic shears in LC in patients without cirrhosis was associ-
ated with a statistically significant shorter mean/median
operative time compared with the conventional clip and
cautery technique.9,1214 This has been attributed to several
factors. First, the Harmonic ACE is a multifunctional instru-
ment that replaces four instruments routinely used in LC,
namely the dissector, clip applier, scissors, and electrosurgical
hook or spatula. Its use, therefore, prevents the frequent blind
extraction and reinsertion of these different instruments with
subsequent avoidance of time loss. Second, the activation of
the Harmonic ACE does not form smoke although mist may
be generated by vibration, therefore allowing the surgeon to
work in a clear operative field throughout the operation. On
the other hand, the use of electocautery causes smoke for-
mation in the abdominal cavity and decreases visibility.
Moreover, smoke must be evacuated by opening the valves of
the trocars, thus causing repeated loss of pneumoperitoneum
and subsequent loss of time. Finally, the use of the Harmonic
ACE in LC has been shown to be associated with a statistically
lavage and spilled stones retrieval.9,12,13 The statistically sig-
nificant shorter median/mean operative time encountered in
the present study and that of El-Nakeeb et al. demonstrates
that the above-mentioned advantages of the harmonic shears
are reproducible when attempting LC in patients with cir-
rhosis.14
LC is the standard treatment for symptomatic cholelithiasis
in patients with cirrhosis who are fit for surgery. The opera-
tion entails complete removal of the gallbladder, which,
whenever possible, should remain to be the target of LC even
in patients with cirrhosis. However, LSC may be an accept-
able alternative in patients with cirrhosis to avoid in-
traoperative bleeding from the liver bed or during dissection
of the cholecystohepatic triangle with subsequent open con-
version and its associated high morbidity and possible mor-
tality. LSC for patients with cirrhosis has been described as
early as 1993.16 The safety and efficacy of LSC in patients with
cirrhosis has been demonstrated by others.5,1517 In the pres-
ent study, although LSC was resorted to in eight patients
(40%) in the HSLC group compared with six patients (30%) in
the CDLC group, however, the types and techniques differed.
Palanivelu et al. standardized the technique of LSC by
classifying it into three categories: LSC I, LSC II, and LSCIII.15
LSC I was recommended in patients with portal hypertension
in whom large collateral vessels may be present in the liver
bed to prevent avulsion of the gallbladder and subsequent
bleeding.15 In this variant of LSC, the posterior wall of the
gallbladder was left intact with the liver and the remnant
mucosa was electrofulgrated.15 Deliberate iatrogenic gall-
bladder perforation with stone spillage is an inevitable step in
LSC I with subsequent loss of time in abdominal lavage and
stone retrieval. In the present study, LSC I was resorted to in
six patients (30%) of the CDLC group compared with no pa-
tient in the HSLC. In the HSLC group, the gallbladder was
separated from its liver bed using multiple bites of the Har-
monic ACE on the tissues in the plane of dissection without
deliberately perforating the gallbladder. The absence of liver
bed bleeding necessitating open conversion in the HSLC
group provided evidence to the safety and efficacy of such
practice. Using this technique seemed to obviate the need for
LSC I in this group of patients.
LSC II was recommended in the setting of a high risk
hilum.15 In patients with cirrhosis, the presence of neo-
vascularity in the hilar region or cavernomatous transforma-
tion of the portal vein renders hilar dissection dangerous. This
may be aggravated by other risk factors such as the deeply
seated hilum, pericholecystic fibrosis, or aberrant anatomy. In
this operation, the infundibulum was divided circumferen-
tially as close to the junction of the gallbladder and cystic duct
as safely possible; the mucosa in the proximal remnant was
either removed by mucosectomy or electrofulgrated; and
the flap was sutured with continuous suture of polygalactin
30.15 Deliberate iatrogenic gallbladder perforation with
stone spillage is an inevitable step in LSC II when performed
 CLIPLESS LAPAROSCOPIC CHOLECYSTECTOMY IN CIRRHOTICS
using the conventional electrocautery. On the other hand, the
performance of LSC II using the Harmonic ACE offers several
advantages over the traditional method. First, the Harmonic
ACE is placed on the infundibulum as close as possible to the
cystic duct-gallbladder junction, thus rendering the remnant
of the gallbladder negligible in size. Palanivelu et al. reported
that relaparotomy for a stone in the gallbladder remnant was
required in three patients (1.1%).15 The use of the Harmonic
ACE results in a nearly total cholecystectomy rather than a
subtotal cholecystectomy and such a problem has not been
encountered in the present study. Second, the Harmonic ACE
achieves complete and safe closure of both cut ends. The
absence of either minor or major bile leaks in patients
who underwent LSC II in the present study denotes that the
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Harmonic ACE achieved safe and complete closure of the
gallbladder stump. Palanivelu et al. reported bile leakage from
the closed stump in 94.1% of their patients who underwent LSC
II using the traditional method.15 Further, since the gallbladder
was not perforated, neither bile nor stones were spilled into the
peritoneal cavity and no time was lost in abdominal lavage or
spilled stones retrieval. Finally, the use of the Harmonic ACE
rendered separation of the gallbladder from hilar structures
almost bloodless. The absence of common bile duct injuries in
those patients adds further evidence to the safety of LSC II
when performed using the Harmonic ACE.
The findings of the present study demonstrated two addi-
tional benefits to the use of the harmonic shears when
attempting LC in patients with cirrhosis. First, the use of the
Harmonic ACE has seemed to facilitate the performance of LSC
II. The avoidance of bleeding during dissection of a high-risk
hilum, gallbladder perforation, and leaving a sizable remnant
of the gallbladder in which stones may form are the main ad-
vantages of using the Harmonic ACE in LSC II. Second, the use
of the Harmonic ACE seemed to obviate the need for LSC I,
which is associated with deliberate iatrogenic gallbladder
perforation. This was achieved without liver bed bleeding ne-
cessitating open conversion. Further, since the LSC I was
avoided, consequently LSC III was avoided as well. Although
larger numbers are still required to draw more definite con-
clusions on the safety and efficacy of the Harmonic ACE in the
performance of LSC II, however, the absence of bile leaks,
common bile duct injury, and open conversion in the HSLC
group seem to provide encouraging evidence.
Conclusions
In patients with cirrhosis, the use of the harmonic shears in
LC provided a superior alternative to the conventional dia-
thermy in terms of shorter operative time, less intraoperative
blood loss, and lower incidence of gallbladder perforation,
partly through facilitating the performance of LSC.
Disclosure Statement
No competing financial interests exist.
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Address correspondence to:
Samer S. Bessa, MD
Department of General Surgery
Faculty of Medicine
University of Alexandria
20 Ismail Serry St. Semouha
Alexandria 44118
Egypt
E-mail: samerbessa@gmail.com
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