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Single-Incision Laparoscopic Cholecystectomy: A Review of the Evidence
- 1. REVIEW ARTICLE
Single-Incision Laparoscopic Cholecystectomy
A Systematic Review
Thomas C. Hall, MRCS; Ashley R. Dennison, MD; Dilraj K. Bilku, MRCS;
Matthew S. Metcalfe, MD; Giuseppe Garcea, MD
Objectives: To compare the morbidity, pain, cosmesis, and cost-effectiveness of single-incision laparoscopic cholecystectomy (SILC) with standard laparoscopic cholecystectomy (SLC).
Data Sources: Existing literature in MEDLINE through
July 31, 2011.
Study Selection: We reviewed all studies identified
through MEDLINE. References were cross-checked to ensure capture of cited pertinent articles. Case reports and
series of less than 4 cases were excluded.
Data Synthesis: In total we analyzed 49 studies, including 2336 patients. Seven studies consisted of randomized
trials and 11 of case-matched control series (compared with
SLC). The technical aspects of SILC were not standardized. Median follow-up time was 4 weeks, although 27 stud-
S
ies (55.1%) reported no follow-up. The overall median complication rate was 7.37% (range, 0-28.6%), and the overall
rate of biliary duct complications was 0.39%. Postoperative pain was similar or worse in SILC compared with SLC
in 10 of 13 articles reporting pain outcomes (76.9%). Six
articles investigating cosmesis after SILC compared outcomes with those of SLC. Three articles demonstrated significantly improved cosmesis after SILC.
Conclusions: The perceived benefits of SILC compared with SLC are improved cosmesis and reduced surgical trauma. No definitive evidence suggests that such
improvements can be gained by SILC. Complications are
more common, may be underestimated owing to the lack
of sufficient follow-up, and may be associated with a shift
from safe practice.
Arch Surg. 2012;147(7):657-666
URGERY REMAINS THE MAIN-
stay of treatment for biliary
disease, and Navarra et al1 first
described the laparoscopic
removal of a gallbladder
through multiple ports in a single periumbilical incision in 1997. Single-incision laparoscopic operations have emerged
recently for a range of benign and malignant disease as a putatively less invasive
alternative to conventional laparoscopic
surgery.
See Invited Critique
at end of article
Author Affiliations:
Department of Hepatobiliary
and Pancreatic Surgery,
University Hospitals of
Leicester, Leicester, England.
The perceived benefits of single-incision laparoscopic operations compared
with conventional laparoscopy include reduced wound pain, improved cosmesis, expedited return to routine activity, and higher
patient satisfaction. Although the feasibility of single-incision laparoscopic cholecystectomy (SILC) has largely been estabARCH SURG/ VOL 147 (NO. 7), JULY 2012
657
lished,2 it remains unclear whether SILC
represents an improvement in patient care,
particularly because a large-scale adoption of such a technique would result in significantly higher costs in the treatment of
gallstone disease.
The aim of this systematic review was
to critically appraise the available literature evaluating the efficacy and safety of
SILC and make comparisons where possible with standard laparoscopic cholecystectomy (SLC). Because the strongest
and probably the only arguments for SILC
are the purported cosmetic benefit and reduced postoperative pain, we focused on
these aspects in addition to examining the
safety of the procedure.
METHODS
We undertook a MEDLINE literature search
using the keywords cholecystectomy, single port,
single incision, single site, single access, transumbilical, SILS, LESS, R-port, and Tri-port. We
included adult human studies reporting out-
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- 2. 144 Studies identified through
MEDLINE and cross-references
12 Case reports with <4 patients excluded
123 Studies after duplicates removed
123 Potentially appropriate articles to
be included in systematic review
74 Full-text articles excluded as irrelevant
22 Describing a technique
7 Included other single-incision operations
2 Reviews
2 Letters/commentaries
1 Inadequate complication data
40 Not relevant
analog scale, narcotic requirements, and numerical rating scores (Table 2). The timing of pain scoring also
differed between studies, varying from 1 postoperative
day and the 2-week follow-up.
Thirteen studies compared postoperative pain in a
SILC group with that in an SLC group.† Seven articles
demonstrated no significant difference between
cohorts,3,7,25,31,34,40,51 whereas 2 articles described a nonsignificant trend toward increased pain in the singleincision operation.32,38 The article by Lai et al28 demonstrated a similar visual analog scale result at 6
postoperative hours, but on day 7 the SILC group had
significantly worse pain than the SLC group. The remaining 3 articles demonstrated significantly reduced
postoperative pain in the SILC cohort.4,24,48
49 Studies included in final review
COSMESIS
Figure. Flow diagram for the systematic review from the Preferred Reporting
Items for Systematic Reviews and Meta-analyses statement.
comes of SILC and limited the search to any English-language
article published through July 31, 2011. We excluded articles
relating to single-incision procedures in a combination of operations unless data from the cholecystectomies could be extracted. We cross-checked the references in all articles retrieved to ensure capture of cited pertinent articles. A flow
diagram of the selection process according to the statement on
Preferred Reporting Items for Systematic Reviews and Metaanalyses is presented in the Figure. The primary end point was
morbidity as a result of the procedure. Secondary end points
included cosmesis, pain, cost, learning curve, and safety with
regard to the critical view.
RESULTS
In total, we analyzed 49 studies that met the inclusion
criteria with a total of 2336 patients.3-51 These studies included 7 randomized controlled trials3,28,31,32,34,48,51 and 11
case-matched studies comparing outcomes with those of
SLC. Most of the studies were case series. Two articles
described fewer than 10 patients.20,23 Study size ranged
from 4 to 297 patients (Table 1).
Articles were published from 2008 through 2011.
Twenty-seven articles (55.1%) recorded no follow-up. The
remaining studies described follow-up at a median of 4
postoperative weeks (range, 1 week to 26 months).
Surgical technique and devices varied. Devices described included 3 trocars inserted through a single incision, specially designed multiluminal devices, magnetic forceps, improvised surgical gloves as ports, and
robotic devices. Frequently the same article described outcomes using various techniques during the study period, and this heterogeneity made objective outcome comparisons difficult.
Seven studies investigated patient perception of cosmesis after SILC (Table 2).3,17,28,31,32,34,51 Modes of assessing
cosmesis varied between studies. Subjective satisfaction
scores were used in 5 articles.28,31,32,34,51 Three studies using
a wound satisfaction score found a significantly improved cosmetic appearance for SILC compared with
SLC.3,28,31 Another study demonstrated no significant difference in self-assessment score.51
The study by Marks et al34 incorporated a number of
validated scores of cosmetic outcome. The 10-point photographic series questionnaire demonstrated significant
improvements in wound satisfaction with SILC compared with SLC at 2 postoperative weeks and 3 postoperative months. However, this scoring system could
introduce selection bias. The 21-point body-image cosmetic score also showed significant cosmetic improvement with SILC. However, the modified Hollander Incision Attribute Satisfaction Subscale score and the 8- and
12-Item Short Form Health Surveys showed no significant difference.
A study by Ma et al32 used a 10-point score and found
no difference between cohorts. The remaining article by
Fumagalli et al17 asked patients to subjectively evaluate
their satisfaction with the scar. They described 1 patient
(4.8%) as unhappy with the cosmetic result.
COST-EFFECTIVENESS
In total, 17 articles investigated postoperative pain.* Pain
scores used varied between studies to include the visual
Three articles investigated the costs of SILC (Table 3).4,7,19
However, none of these specified a single-incision device. This finding may reflect the fact that a number of
studies were performed with financial support from industry. Two studies reporting cost implications investigated an improvised surgical glove method and demonstrated significantly reduced costs compared with SLC.4,19
Both articles described the costs of the improvised surgical glove port as approximately one-quarter of the costs
of SLC. In contrast, Chang et al7 used an unspecified SILC
port and described costs as greater than SLC costs ($2547
vs $1976). No study performed with the aid of industrial grants declared financial implications.
*References 3, 4, 7, 17, 24, 25, 27, 28, 31, 32, 34, 36, 38, 40, 41,
48, 51.
†References 3, 4, 7, 24, 25, 28, 31, 32, 34, 38, 40, 48, 51.
PAIN
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- 3. Table 1. Studies Investigating Outcomes of SILC
Source
No. of Patients
Aprea et al,3 2011
Asakuma et al,4 2011
Bucher et al,5 2009
Carr et al,6 2010
Chang et al,7 2011
Chow et al,8 2009
Curcillo et al,10 2010
Cuesta et al,9 2008
Dominguez et al,11 2009
Duron et al,12 2010
Edwards et al,13 2010
Elsey and Feliciano,14 2010
Erbella and Bunch,15 2010
Fronza et al,16 2010
Fumagalli et al,17 2010
Han et al,18 2011
Hayashi et al,19 2010
Hirano et al,20 2010
Hodgett et al,21 2009
Hong et al,22 2009
Ito et al,23 2010
Khambaty et al,24 2011
Kilian et al,25 2011
Kravetz et al,26 2009
Kroh et al,27 2011
Langwieler et al,29 2009
Lee et al,30 2009
Ma et al,32 2011
MacDonald et al,33 2010
McGregor et al,35 2011
Mutter et al,36 2008
Palanivelu et al,37 2008
Philipp et al,38 2009
Podolsky et al,39 2009
Prasad et al,40 2011
Qiu et al,41 2011
Rao et al,42 2008
Rawlings et al,43 2010
Rivas et al,44 2010
Roberts et al,45 2010
Tacchino et al,47 2009
Romanelli et al,46 2010
Tsimoyiannis et al,48 2010
Wen et al,49 2011
Zhu et al,50 2009
Lee et al,31 2010
Lai et al,28 2011
Marks et al,34 2011
Gangl et al,51 2011
Type of Study
25
24
11
60
30
14
297
10
40
55
80
238
100
21
21
150
20
4
29
15
8
107
16
20
13
14
37
21
30
11
61
10
29
15
100
80
20
54
100
56
12
22
20
50
10
35
Randomized prospective trial
Prospective trial
Case series
Case series
Retrospective case-matched series
Case series
Retrospective multicenter
Case series
Case series
Case series
Case series
Case series
Case series
Retrospective case-matched series
Case series
Case series investigating learning curve
Case series
Case series
Case-control series
Case series
Case series
Case series
Observation prospective study
Retrospective case series
Case series
Case series
Case series
Randomized controlled trial
Case series
Case series
Prospective case series
Case series
Retrospective case-matched series
Consecutive case series
Consecutive case series
Case series
Case series
Case series
Case series
Case series
Case series
Prospective case series
Randomized controlled trial
Case series
Case series
Randomized controlled trial
24
50
67
Randomized controlled trial
Randomized controlled trial
Randomized controlled trial
Outcomes Compared With SLC
Yes, 25 SLC
Yes, 25 SLC
No
No
Yes, 30 SLC
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes, 29 SLC
No
Yes, 23 SLC
Yes, 44 SLC
Yes, 20 SLC
Yes, 20 three-port SLC
No
Not directly
No
Yes
No
Yes, 24 SLC
No
No
Yes, 22 SLC
No
Yes, 100 SLC
No
No
No
No
No
No
No
Yes, 20 SLC
No
No
No, 35 minilaparoscopic
cholecystectomy
Yes, 27 SLC
Yes, 33 SLC
Yes, 67 SLC
Abbreviations: SILC, single-incision laparoscopic cholecystectomy; SLC, standard laparoscopic cholecystectomy.
LEARNING CURVE
Eleven studies examined the effect of the learning curve
on operating times (Table 3).‡ The median operating time
across studies was 80.75 (range, 40-186) minutes
(Table 4). Among the 16 studies comparing outcomes
with those of SLC, operating times were significantly increased in SILC in 9 studies.§ The remaining 7 studies
‡References 8, 17, 18, 24, 26, 32, 36, 41, 46, 47, 51.
§References 3, 7, 16, 23, 24, 32, 34, 48, 51.
contained a nonsignificant trend toward longer operating times.
Apart from 1 study,36 a consistently reduced operating time was observed in the authors’ institutions after
the introduction of SILC (Table 4). A plateau of operating time was achieved after a median 8.5 (range, 3-20)
cases. The study by Kravetz et al26 concluded that operating times could be matched to SLC after 5 cases. One
study21 demonstrated consistent operating times for the
29 patients undergoing SILC, and another did not show
any significant reduction in times.36
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- 4. Table 2. Outcomes of SILC
External Retraction,
Transparietal Sutures
Source
3
Aprea et al, 2011
Asakuma et al,4 2011
Yes; also used in SLC
No
Yes, 2
Bucher et al,5 2009
1
Carr et al,6 2010
Yes, 1
Chang et al,7 2011
No
Chow et al,8 2009
Yes occasionally, 1
Curcillo et al,10 2010
1
Cuesta et al,9 2008
No
Dominguez et al,11 2009
Yes, 1
Duron et al,12 2010
Yes, 2
Edwards et al,13 2010
Yes, 2 in select cases
Elsey and Feliciano,14 2010
Yes, 3
Erbella and Bunch,15 2010
Yes, 38% required 1 or 2
Fronza et al,16 2010
No
Fumagalli et al,17 2010
Yes, 26.7% intraoperative spillage of bile
Han et al,18 2011
No
Hayashi et al,19 2010
Miniloop retractor in right subcostal area
Hirano et al,20 2010
2
Hodgett et al,21 2009
No
Hong et al,22 2009
No
Ito et al,23 2010
No
Khambaty et al,24 2011
Kilian et al,25 2011
Kravetz et al,26 2009
Kroh et al,27 2011
No
18/20 Required 1
No
Langwieler et al,29 2009
Lee et al,30 2009
Ma et al,32 2011
No
No
No
MacDonald et al,33 2010
McGregor et al,35 2011
Mutter et al,36 2008
Palanivelu et al,37 2008
Philipp et al,38 2009
No
2
11 Sutures, and 4 patients required port-free
endocavity retractor (EndoGrab; Virtual
Ports Ltd)
No
1-3
Podolsky et al,39 2009
Prasad et al,40 2011
Qiu et al,41 2011
No
No
No
Rao et al,42 2008
Rawlings et al,43 2010
Rivas et al,44 2010
Roberts et al,45 2010
Tacchino et al,47 2009
Romanelli et al,46 2010
Tsimoyiannis et al,48 2010
7 (35%)
Yes, 2
2 or 3
1
2
1 or 2
1
Wen et al,49 2011
Zhu et al,50 2009
Lai et al,28 2011
No
No
2
Lee et al,31 2010
Yes, 1 (selected cases)
34
Marks et al, 2011
No
Gangl et al,51 2011
Yes, 1 or 2
Pain
No difference
Median 1-d VAS, 24 (SILC) vs 45
(P=.002)
Not assessed
Not assessed
No significant difference
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Median 1-d VAS, 3 (range, 0-6)
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Reduced narcotic use in SILC group,
20 (SD, 22.7) vs 32 (SD, 31.2) mg
(P=.02)
No difference
Not assessed
At 2 wk, mean 1 (range, 0-5) of possible
0-10
Not assessed
Not assessed
Nonsignificant trend toward more pain in
SILC group at discharge; mean score,
2.7 vs 1.8
Not assessed
Not assessed
1-d VAS, 2.26 (SD, 1.81)
Not assessed
Tendency toward increased pain in SILC
group
Not assessed
VAS, 2.78 vs 2.62 (SILC) (P=.18)
8-h Postoperative numerical rating scale,
2.3 (SD, 1.6)
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Reduced with SILC, 72-h VAS, 0.05 (SD,
0.22) vs 0.85 (SD, 0.67)
Not assessed
Not assessed
6-h VAS, 4.5 (SILC) vs 4.0 (SLC) (P=.20)
7-d VAS, 1 SILC vs 0 SLC (P=.048)
1-d VAS, 2.1 (SILC) vs 2.2 (SLC) (P=.48)
No significant difference in worst or
average pain
VAS and analgesic requirements at 24 and
48 h, no significant difference
Cosmesis
At 7 d, SILC better (PϽ.05)
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
4.8% Dissatisfied with scar
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
No difference on 10-point scale
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Not assessed
Median cosmetic score at 3 mo,
7 (SILC) vs 6 (SLC) (P=.02)
At 1 mo, 8.7 (SILC) vs 7.7 (SLC)
(P=.001); at 6 mo, 9.1 vs 8.4 (P=.04)
Mixed outcomes, see results
No difference on self-assessment of
satisfaction with cosmetic outcomes
Abbreviations: SILC, single-incision laparoscopic cholecystectomy; SLC, standard laparoscopic cholecystectomy; VAS, visual analog scale.
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- 5. Table 3. Socioeconomic Outcomes of SILC
Source
Follow-up
Complications
Learning Curve
Aprea et al,3 2011
Asakuma et al,4 2011
None
None
None in either group
None in either group
NA
NA
Bucher et al,5 2009
Carr et al,6 2010
None
1y
NA
NA
Chang et al,7 2011
Mean, 28 (range,
2-42) wk
None
None
3 Minor (wound infection, pneumonia, urinary
retention)
None
Chow et al,8 2009
Curcillo et al,10 2010
Cuesta et al,9 2008
Dominguez et al,11 2009
Duron et al,12 2010
Edwards et al,13 2010
Elsey and Feliciano,14
2010
Erbella and Bunch,15 2010
Fronza et al,16 2010
1-24 mo
1 wk
None
0.5-2 y
Mean, 4.7 mo in
79%
None
6 mo to 1 y
None
1 Bile leak (Luschka duct)
26; No duct injury or hernia
None
1 Port-site infection
None
3 Bile leaks, 2 cellulitis, 2 urinary retention (total,
8.7%)
5 Port-site hematoma (1.3%), skin dehiscence at
umbilical wound (0.8%)
None
1 Atypical CP, 1 skin dehiscence, 1 nausea and
vomiting
None
Fumagalli et al,17 2010
None
Han et al,18 2011
None
10% Complications, 1.4% duct injury, 5.3%
wound infection
Hayashi et al,19 2010
None
None
Hirano et al,20 2010
Hodgett et al,21 2009
Hong et al,22 2009
Ito et al,23 2010
Khambaty et al,24 2011
Not specified
None
1 wk
None
11 (range, 2-18) mo
Kilian et al,25 2011
Kravetz et al,26 2009
None
None
None
Minor; 1 urinary retention, 2 pain control issues
None
None
2 (7.6%) In converted SILC group; hemostasis
from gallbladder fossa and CBD stone needing
postoperative ERCP
None
None
Kroh et al,27 2011
2 wk
None
NA
Improved with time; Pearson
coefficient, −0.56
NA
NA
NA
NA
NA
Cost
NA
£100 (SILC)
vs £395
NA
NA
$2547 (SILC)
vs $1976
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Reduced time with
experience (71 to 56 min)
Reduced time after 20 cases,
1 operator achieved
learning curve plateau
after 8.5 cases
NA
NA
NA
NA
NA
NA
After 10th case, no difference
in time
NA
Time equivocal to SLC after
5 cases
NA
NA
$147 Cost of port
compared with
ϫ4 for SLC
NA
NA
NA
NA
NA
NA
NA
NA
(continued)
Most studies reported operations that were performed by a single surgeon or group of consultant surgeons for whom the specialist area was often minimally
invasive surgery. Some articles, however, described the
procedure as performed by residents. No study reported
the nature of the residents’ training.
SAFETY
The overall median complication rate was 7.37% (range,
0-28.6%). Frequently, studies reported local complications, but these were not defined. The overall rate of bile
duct injury was 0.39% (9 of 2336) across all studies
(Table 3). Four leaks were secondary to accessory ducts.
Because follow-up after single-incision procedures was
highly variable and in many cases was not documented,
this figure may underestimate this complication in terms
of diathermy injuries leading to delayed stricturing of the
bile duct.
In articles reporting follow-up (1151 patients), 4 instances of incisional hernia occurred, giving an overall
rate of 0.35%. Because length of follow-up varied and was
only 2 weeks in some articles, this figure may underestimate true incisional hernia rates.
A clear view or a “critical view of safety” in identifying relevant anatomy in the cholecystectomy triangle is
essential to reduce the risk of ductal injury. Thirty-four
articles (69.4%) did not explicitly describe the surgeon’s perspective of views obtained. The article by Rawlings et al43 investigated specifically the critical view of
safety in the SILC of 54 patients. The group used a 3-point
grading system, namely, visualization of only 2 ductal
structures entering the gallbladder, a clear view of the
Calot triangle, and separation of the base of the gallbladder from the cystic plate. All 3 criteria were met in 64%,
2 were met in 24%, 1 was met in 6%, and none were met
in 6% of cases. A study by Han et al18 reported outcomes
of 150 SILCs performed using the improvised surgical
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- 6. Table 3. Socioeconomic Outcomes of SILC (continued)
Source
Follow-up
None
Not stated
Ma et al,32 2011
Not stated
MacDonald et al,33 2010
McGregor et al,35 2011
Mutter et al,36 2008
6 wk
2 mo
None
Palanivelu et al,37 2008
Philipp et al,38 2009
Podolsky et al,39 2009
Prasad et al,40 2011
Qiu et al,41 2011
6 mo
4 wk
2y
None
None
Rao et al,42 2008
Rawlings et al,43 2010
Rivas et al,44 2010
None
31 (SD, 9.7) d
1 mo
Roberts et al,45 2010
None
Tacchino et al,47 2009
None
Romanelli et al,46 2010
None
Tsimoyiannis et al,48 2010
Wen et al,49 2011
Zhu et al,50 2009
Lai et al,28 2011
Lee et al,31 2010
Marks et al,34 2011
Gangl et al,51 2011
None
None
1 mo
3 mo
Yes; not specified
3 mo
17-26 mo
Complications
Learning Curve
Cost
None
2 Right hepatic duct injury and bile leak,
mesentery injury
3 Wound infections, 1 retained stone, 1 port-site
hernia, 1 postoperative hemorrhage
No
No intraoperative complications
None
Langwieler et al,29 2009
Lee et al,30 2009
NA
NA
NA
NA
Trend toward reduced
operating time
NA
NA
Operating time not reduced
with time
NA
NA
NA
NA
Reduced operating time after
20 cases
NA
NA
NA
NA
1 Bile leak (cystic duct)
6 Minor local complications
2 Umbilical wound seromas
None
1 UTI, 2 severe nausea and vomiting possibly
secondary to anesthetic
None
2 Wound infections
2 Readmitted with abdominal pain of unknown
cause, 1 retained stone
3 (5.4%), Including 1 collection, 1 Luschka duct
leak, and 1 retained stone
Minor; 1 wound hematoma, 1 fluid collection
1 Richter hernia at fascial defect requiring
resection
None
2 Wound seroma
None
None
1 Urinary retention
1 Incisional hernia
No major; 1 subhepatic hematoma, 1 incisional
hernia
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Reduced operating time after
3 operations
Experience reduced times;
Pearson coefficient, −0.44
NA
NA
NA
NA
NA
NA
Reduced operating times in
the cohort of 1 surgeon
NA
NA
NA
NA
NA
NA
NA
NA
NA
Abbreviations: CBD, common bile duct; CP, chest pain; ERCP, endoscopic retrograde cholangiography; NA, not applicable; SILC, single-incision laparoscopic
cholecystectomy; SLC, standard laparoscopic cholecystectomy; UTI, urinary tract infection.
glove method. They recorded poor views of the Calot triangle in 34% of cases. In their case series of 12 patients
using the 3-trocar technique, Tacchino et al47 also described poor views.
Single-incision cholecystectomy was performed without the addition of extra ports (not including transparietal sutures) in 91.25% of operations. Reasons for additional ports included insufficient views, dense adhesions,
insertion of a choledochoscope, bleeding, inability of the
instruments to reach from the umbilicus, and gallbladderduodenal fistula. One or more additional ports were required in a median of 8.55% of SILCs (range, 1.3%66.7%). The rate of open conversion across studies was
0.43% (n=10).
Ease of surgery was also affected by the indication. Although in all studies cholecystectomy was performed for
benign disease, the presentation differed between uncomplicated gallstone disease and acute cholecystitis. Seventeen studies included patients with acute cholecystitis. Patient characteristics, such as body mass index,
previous upper abdominal surgery, and local anatomical considerations, added challenges. Many series reported cholecystectomy after bariatric procedures, which
References 5-7, 12-14, 18, 24, 26, 33, 35, 36, 38, 44, 45, 49, 51.
will inevitably become increasingly common as the number of these procedures increases.
Twenty-six articles (53.1%) described the routine or
selective use of transparietal sutures or other method of
retraction to improve visualization of the Calot triangle
(Table 2). Such sutures frequently resulted in the intraoperative spillage of bile and reduced the mobilization
of the Hartmann pouch during dissection.
Although a source of debate in SLC, the routine use
of intraoperative cholangiography has been described as
resulting in reduced ductal injuries. Intraoperative cholangiography was attempted selectively or routinely in 15
studies (30.6%). Success in performing intraoperative
cholangiography was described in 66.7% to 100% of cases.
COMMENT
Technical innovation within surgery is laudable, and the
progress that results is generally a consequence of the
quest to achieve optimum outcomes for patients. However, the advances in surgical technique must improve
or at least maintain (and certainly not at the expense of)
established safe principles. Perceived improvements in
patient satisfaction (with cosmetic outcomes and reduc-
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- 7. Table 4. Intraoperative Outcomes
Source
Indication for SILC
Operating Time, min
Additional Ports
Aprea et al,3 2011
Uncomplicated disease; no previous abdominal
surgery, BMI Ͻ30
Longer in SILC; mean 41.3 vs
35.6
Asakuma et al,4 2011
100 vs 110 (SILC) (PϾ.05)
Median, 52 (range, 40-77)
None
Median, 51 (SD, 21)
Mean, 86 (SILC) vs 58
(PϽ.001)
Mean, 142.9
Mean, 71
Mean, 70 (range, 65-85)
Mean, 93 (range, 55-130)
4.8% Converted to SLC
None
None
34 Patients
None
None
Mean, 66.5 (range, 30-140)
5 Patients
69.5 (range, 29-126)
9 Patients
Mean, 40
2.5% Required more ports
Not stated
100 (SILC) vs 65
65 (range, 40-122)
77.6 (SD, 28.5)
2 Converted to SLC
2 Required Ͼ1 port
1 Converted to SLC
6% Converted to SLC
Hayashi et al,19 2010
Hirano et al,20 2010
Hodgett et al,21 2009
Hong et al,22 2009
Ito et al,23 2010
Uncomplicated disease; no previous abdominal
surgery
7 Biliary colic, 3 previous cholecystitis, 1
previous pancreatitis
Benign disease; 1 acute cholecystitis
Uncomplicated disease; 4 acute cholecystitis in
both groups
Uncomplicated disease; no previous surgery
Benign disease
Not stated
Uncomplicated disease; no previous surgery,
BMI Ͻ40
Benign disease; 6 acute cholecystitis, 1 acute
pancreatitis
Did include some acute cholecystitis; unknown
number
25% Acute cholecystitis, 75% uncomplicated
disease
Not stated
Uncomplicated disease; no acute cholecystitis
Uncomplicated disease; no previous surgery
Benign disease; 6 acute cholecystitis, 136
chronic cholecystitis
Not stated
Chronic cholecystitis and gallstones
Unspecified gallbladder disease
Not stated
Not stated
2 SILC patients (control bleeding
and drain placement); 1 SLC
patient for liver lobe hypertrophy
None in either
None
None
2 Required extra ports
None
None
Khambaty et al,24 2011
Benign disease including acute cholecystitis
Kilian et al,25 2011
Benign disease
Mean, 110 (range, 55-170)
Mean, 88.8
72 (P=.81)
Mean, 79 (range, 35-165)
SILC with new port, 120 (SD,
11); conventional SILC, 154
(SD, 57)
81.5 (SD, 28) SILC vs 69.1 (SD,
21) (PϽ.004)
SILC, 65 (range, 35-95) vs 55
(range, 35-135) (P=.56)
Kravetz et al,26 2009
Benign disease including 20% acute
cholecystitis
85% Chronic cholecystitis, 15% gallstone
pancreatitis
Bucher et al,5 2009
Carr et al,6 2010
Chang et al,7 2011
Chow et al,8 2009
Curcillo et al,10 2010
Cuesta et al,9 2008
Dominguez et al,11 2009
Duron et al,12 2010
Edwards et al,13 2010
Elsey and Feliciano,14
2010
Erbella and Bunch,15 2010
Fronza et al,16 2010
Fumagalli et al,17 2010
Han et al,18 2011
Kroh et al,27 2011
First 5 cases, mean, 104.0; next
15, mean, 68.2
107 (SD, 54)
24% Converted to SLC
2 (12%) Additional port for Calot
triangle dissection; 1 (6%)
converted to SLC for cystic
artery bleed
2 Additional ports because liver in
way
1 (7.7%) For gallbladder necrosis
(continued)
tion of pain and surgical trauma) must not increase complications or mandate deviations from safe surgical practice. The aims of this review were to assess morbidity and
patient-specific outcomes after SILC and to make comparisons, where possible, with SLC.
Advocates of SILC cite improved cosmesis and reduced surgical trauma (and therefore pain) as reasons for
adopting this technique. Despite this, the patient’s perspectives of cosmesis and postoperative pain have been
poorly investigated and are difficult to assess in an objective fashion. In particular, the advent of the Internet
makes this investigation difficult. Demands for the latest procedures are often based on information that is not
based on evidence but rather is driven by commercial interests or the biotechnology industry. The most common complaint after SLC is related to the umbilicus. The
SILC will inevitably create a bigger incision. Five studies3,17,28,31,51 objectively investigating cosmetic outcomes
of SILC compared with SLC and with differing outcomes lead to no firm evidence of this assumption. Only
the study by Marks et al34 used a validated scar questionnaire on which to base conclusions.
The issue of cosmesis sidesteps the issue of whether
surgeons should suspect patient dissatisfaction with SLC
scars and whether this issue can be improved. A study
by Bignell et al52 retrospectively investigated patients’ satisfaction with cosmesis after SLC in 380 patients using a
validated scar questionnaire. Among the 195 patients who
responded, 92% were satisfied or extremely satisfied with
the cosmetic outcomes after 4 years. This high rate of patient satisfaction with SLC is supported by other series.53 Improvements in cosmesis therefore seem difficult to achieve when high rates of satisfaction exist in
established techniques.
The assumption that implementing a single incision
reduces postoperative pain is also not largely supported
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- 8. Table 4. Intraoperative Outcomes (continued)
Source
Langwieler et al,29 2009
Lee et al,30 2009
Ma et al,32 2011
MacDonald et al,33 2010
Indication for SILC
Operating Time, min
McGregor et al,35 2011
Not stated
Benign disease
Benign disease
Benign disease; 4 acute cholecystitis, 4
gallstone pancreatitis
Benign disease including acute cholecystitis
Mutter et al,36 2008
Palanivelu et al,37 2008
58 Benign disease; 3 acute cholecystitis
Benign disease
68.4 (SD, 26.98)
Mean, 148
Philipp et al,38 2009
Podolsky et al,39 2009
Prasad et al,40 2011
Benign disease; 2 (7%) acute cholecystitis
Benign disease
Benign disease; no acute cholecystitis
Qiu et al,41 2011
Rao et al,42 2008
Benign disease; no acute cholecystitis
Benign disease; no acute cholecystitis
85 vs 67 (P=.01)
Mean, 107
67 (SD, 5.78) (SILC) vs 28 (SD,
1.35) (PϾ.05)
46.9 (SD, 14.6)
Mean, 40 (range, 19-100)
Rawlings et al,43 2010
Rivas et al,44 2010
Mean, 113.1 (SD, 27.9)
Mean, 50.8 (range, 23-120)
Roberts et al,45 2010
Benign disease; no acute cholecystitis
Benign disease; 5% acute cholecystitis or
gallstone pancreatitis
Benign disease; 9% acute cholecystitis
Tacchino et al,47 2009
Romanelli et al,46 2010
Not stated
Benign disease
Mean, 55 (SD, 7)
Mean, 80.8 (range, 51-156)
Tsimoyiannis et al,48 2010
Wen et al,49 2011
Benign disease excluding acute cholecystitis
and gallstone pancreatitis
Benign disease; 20% with acute cholecystitis
Zhu et al,50 2009
Lee et al,31 2010
Lai et al,28 2011
Not stated
Benign disease; no acute cholecystitis
Benign disease; no acute cholecystitis
Marks et al,34 2011
Gangl et al,51 2011
Benign disease; no acute cholecystitis
Benign disease; 13.4% acute cholecystitis
49.65 (SD, 9.02) (SILC) vs 37.3
(SD, 9.16)
73 (SD, 2) chronic cholecystitis;
95 (SD, 5) acute cholecystitis
Mean, 62 (SD, 25)
Mean, 71.7 (range, 45-100)
Mean, 43.5 (SD, 15.4) SILC vs
46.5 (SD, 20.1)
53.2 SILC vs 42.0 (P=.003)
75 SILC vs 63 (PϽ.04)
Additional Ports
53-115
83.6 (SD, 40.2)
88.5 (SILC) vs 44.8 (PϽ.001)
35-120
None
5 (13.5%) Converted to SLC
14 Additional ports
10 (33%) Required extra ports
86.91 (SD, 8.97) vs 79.68 (SD,
4.24) (PϾ.05)
3 Converted to SLC secondary to
poor visibility or unclear
anatomy
4 Patients
4 Converted to SLC (2 for difficult
dissection and 2 for bleeding)
15 (52%) Required extra ports
1 Secondary to large liver
No
Mean, 80 (range, 41-186)
1 For gallbladder-duodenum fistula
3 (2 For insertion of
choledochoscope)
6 Patients (11%)
13% Extra ports or 3-channel
device
1 Converted to SLC for gangrenous
gallbladder
0
1 Converted to SLC because
instruments unable to reach
No
2 Secondary to dense adhesions in
acute cholecystitis
None
2 Patients
0
0
9 Converted to SLC (1 open
conversion)
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); SILC, single-incision laparoscopic cholecystectomy;
SLC, standard laparoscopic cholecystectomy.
by the results of this review. Thirteen studies have investigated pain and, of these, (76.9%) report similar or
worse pain after SILC compared with SLC. Increased pain
with the SILC technique may be the result of lengthier
operating times and subsequent abdominal wall tension
that may improve with the learning curve.
Difficulties arise in interpreting results because heterogeneity exists in surgical technique and the method and
timing of pain scoring. The study by McGregor et al35 investigated the acute-phase response in patients undergoing SILC and compared it with the response in patients
undergoing SLC. They found no difference in interleukin
6 and C-reactive protein levels between the techniques,
indicating that surgical trauma may not be reduced in SILC.
At present, SILC using industry-supplied ports may
be more expensive than SLC, although none of the studies in the review provided any objective costs to support
this possibility. In contrast, the improvised surgical glove
technique was shown to be one-quarter the cost of SLC.
Again, cost is difficult to assess when standardization of
technique does not exist and series are published beyond the current learning curve.
The large driving force behind SILC might have been
commercial marketing; a significant number of the studies in this review are industry funded. This type of activity runs the risk of transforming surgical practice into
a commodity offered to patients in various forms based
on market research.
In terms of safety, SILC appears to have a greater number of complications compared with SLC, although the
learning curve is partly responsible. Operating times are
significantly longer in SILC compared with SLC also owing to the learning curve, and times are consistently reduced after a relatively small number of procedures. Operative difficulties may result from the lack of triangulation,
pneumoperitoneum leaks, and instrument “clashing.”
The primary concern and source of skepticism for many
surgeons considering the place of SILC is the frequent deviation from safe standards and the lack of evidence that
such techniques offer any real benefit to the patient. However, the introduction of laparoscopic cholecystectomy
nearly 20 years ago saw a rise in the incidence of ductal
injury. However, the reaction by the surgical community
was not to abandon the laparoscopic procedure. Instead,
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- 9. the American College of Surgeons reviewed causes of this
complication and made suggestions regarding safer outcomes. The critical view of safety was defined by Strasberg
and Brunt54 to aid dissection in relation to the cystic duct
and common bile duct with the aim of preventing ductal
injury. Questions remain whether the paradigm of conventional laparoscopic surgery can be further improved
by reducing the number of ports used and whether any
marginal benefits are cost-effective.
Concerns have been raised whether the hepatocystic
triangle truly can be prepared in SILC using transparietal sutures.55,56 Such sutures are advocated by 55.6% of
authors routinely or selectively. The routine use and number of additional sutures varied considerably depending
on the authors’ institution and may contribute to the complications if the critical view of safety is suboptimal. Traction by static sutures does not allow caudolateral movement and may reduce mobile exposure. In unsuspected
malignant neoplasms in the gallbladder, the use of sutures may also promote peritoneal dissemination.57
The rates of bile duct injuries and minor or local complications in this review exceed those found in SLC. An
overall complication rate of 7.37% and a ductal injury
rate of 0.39% were demonstrated; because follow-up is
frequently absent or extremely short in studies reporting outcomes, these figures almost certainly underestimate complications, particularly the delayed presentation of ductal injury. The rates of complications such as
port-site hernia will also be underestimated, again owing to the lack of long-term results. The complication rates
in this review are higher than those reported for SLC, in
which ductal complications occur in less than half as many
(0.2%) cases and the overall complication rate is less than
1%.58 However, 4 of the 9 reported bile leaks were secondary to accessory ducts. Complications are frequently not correlated with the surgeons’ experience, including the authors’ rate of complications with SLC, and
may contribute to the varying rates observed.
A possible cause of increased rates of umbilical complications may be the creation of circumferential skin flaps
to accommodate the subcutaneous ports. This complication occurs with the technique of multiple fascial punctures from a single umbilical skin incision to insert multiple ports. The procedure may result in weakening of
the fascia, seroma formation, and late complications, such
as port-site hernia. In addition, the trocar type may influence the complication rate; this may become apparent as more studies reporting outcomes using different
trocars are reported.
Complications such as wound infection may be increased by the SILC technique. We believe that removing
the gallbladder from the umbilical port risks anaerobic microbial seeding in the wound. The use of transparietal sutures increases the rates of intraoperative bile leakage and
may contribute to microbial seeding.
Limitations in drawing conclusions from the current
published literature in SILC include study heterogeneity.
Much variation in technical method, trocar type, instrumentation, transparietal suture use, surgeon experience,
and the learning curve is reported. These factors may all
contribute to the disparity in reported outcomes.
CONCLUSIONS
Although SILC is feasible, the procedure must confer a
significant additional benefit to the patient over SLC if
we are to advocate its selected or routine use and invest
time and energy in its development. Currently, the largest driving forces behind its introduction are from industry and a perceived cosmetic benefit. These cosmetic improvements, however, are not based on evidence,
and no evidence suggests that patients are currently dissatisfied with cosmesis after SLC. At present, SILC increases the risk of local complications and ductal injury. To quote a recent article by Greaves and Nicholson,
“However, as surgeons we should not advocate for slightly
improved cosmetic value over safety.”59(p440)
When the discussion of operative technique takes place,
the patient must be informed of the uncertainties of SILC.
This conclusion is reflected in the recommendations made
by the National Institute for Health and Clinical Excellence (http://www.nice.org.uk) in 2010. Outcomes from
systematic reviews rather than market research must guide
decisions about surgical procedures if we are to ensure
that surgical progress is not dictated by commercial and
industrial interests. Technical advances are essential to
advance surgical practice, but patients must be protected from procedures and technologies with putative
advantages until these can be proven in the context of
properly conducted trials.
Accepted for Publication: January 4, 2012.
Correspondence: Thomas C. Hall, MRCS, Department
of Hepatobiliary and Pancreatic Surgery, University Hospitals of Leicester, Leicester LE5 4PW, England (tch2
@doctors.org.uk).
Author Contributions: Study concept and design: Hall,
Dennison, Metcalfe, and Garcea. Acquisition of data: Hall.
Analysis and interpretation of data: Hall, Dennison, Bilku,
and Garcea. Drafting of the manuscript: Hall, Dennison,
Bilku, Metcalfe, and Garcea. Critical revision of the manuscript for important intellectual content: Hall. Statistical
analysis: Hall and Metcalfe. Administrative, technical, and
material support: Dennison, Metcalfe, and Garcea. Study
supervision: Dennison, Metcalfe, and Garcea.
Financial Disclosure: None reported.
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