SAGES OSAP Journal Club Activity Worksheet
Article: Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic
cholecystectomy versus single-incision laparoscopic cholecystectomy
For release _____________
TO BE COMPLETED BY DON SELZER, MD
1. Please indicate which practice gap this article serves to fill: (you may access the SAGES Practice Gap Bank at
http://sages.niazyselim.net/
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X
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Clinical research related to: ______________________________________________________
Basic science research: __________________________________________________________
Technology and technique: Determine the role of single port laparoscopic cholecystectomy compared to the standard technique
Education: ____________________________________________________________________
Other: _______________________________________________________________________
2. Please review the author disclosures. You need to determine if there are any conflicts of interest.
When do relationships create "conflicts of interest?" (SCS 2.1)
The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both a financial
relationship with a commercial interest and the opportunity to affect the content of CME about the products or services of that
commercial interest.
A. Indicators of COI: Please check all that apply
X None
 Topic is related to the same products or services as company listed in the Financial Disclosure
 Brand names used in materials and bias is perceived
 Article does not provide a balanced discussion of treatment options/products/services
 Other (describe): ____________________________________________________________
B. What methods may be used to manage or resolve the conflict?
X
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


N/A
Changes to article (describe): ___________________________________________________
Addition of references to validate recommendations
Do not use article
Other: _____________________________________________________________________
TO BE COMPLETED BY JC REVIEWER: _Richard M Peterson, MD MPH FACS___________________
3. Please indicate the ABMS/ACGME/IOM competency(ies) this article & the questions will address:
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X
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Patient-centered Care
Work in Interdisciplinary Teams
Evidence-based Practice
Quality Improvement
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Utilize Informatics
X
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X
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Patient Care
Medical Knowledge
Practice Based Learning and
Improvement
Interpersonal Skills and
Communication
Professionalism
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



4. Will this activity change knowledge and/or competence?
X Knowledge (knowing about something)
 Competence (knowing “how to” do something)*
*If you mark competence, the questions asked must be case-based or scenario-based in order to measure this.
Systems Based Practice
Professional Standing
Commitment to Lifelong Learning
Cognitive Expertise
Evaluation of Performance in Practice
5. Please write 4 multiple choice questions with 4 answers, 1 of which is correct – do not use “all of the above.”
Identify which answer is correct. Then write a brief explanation regarding why the correct choice was correct and why
each of the other choices was incorrect. See the Question Writing Guide for suggestions!
1. Phillips et al. identify an assessment of the common indicators for a successful single-incision laparoscopic
cholecystectomy (SILC). Based upon this introductory review, which of the following patients would best be
suited to undergo a SILC?
a. A 32 year old female, BMI 22 with a 1 day history of right upper quadrant pain, ultrasound with
pericholecystic fluid and WBC 16.
b. A 40 year old male, BMI 54 with a history of right upper quadrant pain 1 time in the past year,
ultrasound with gallstones and WBC 9.
a. A 34 year old female, BMI 27 with a history of right upper quadrant pain 1 time in the past year,
ultrasound with gallstones and WBC 9.
a. A 72 year old male, BMI 27 with a history of right upper quadrant pain with multiple ER admissions
requiring antibiotics over the last year, ultrasound with gallstones and WBC 9.
2. In the article presented by Phillips et al, which of the following complications were noted to be significant
between the SILC and four port cholecystectomy (4PLC)?
a.
b.
c.
d.
Bile duct injury or bile leak
Wound complications
Retained choledocholithiasis
Post operative hernia recurrence
3. Phillips et al presented data in their single blinded randomized controlled trial on pain after SILC vs 4PLC. Which
of the following factors was an independent predictor of increased postoperative pain in this study?
a.
b.
c.
d.
SILC
Male gender
4PLC
Age > 65 years
4. Using the data from this study and a review of the literature, the authors evaluated several factors associated
with SILC vs 4PLC. Which of the following statements is NOT true?
a.
b.
c.
d.
There is an increased overall cost of SILC vs 4PLC
There is a similar safety profile of biliary complications
There is an improved cosmesis as perceived by patients with SILC
There is an increased length of operative time with SILC
Answers with Explanations and References
1.
Phillips et al. begin with a brief review of the literature that focuses on recent retrospective reports. During this review, an
assessment of the common indicators for a successful single-incision laparoscopic cholecystectomy (SILC) were identified.
Based upon this introductory review, which of the following patients would best be suited to undergo a SILC?
a.
A 32 year old female, BMI 22 with a 1 day history of right upper quadrant pain, ultrasound with pericholecystic
fluid and WBC 16.
The authors identify Antoniou et al. as a retrospective review that suggests an appropriate candidate for SILC. This
patient has an elevated WBC and a 24 hour history of right upper quadrant pain. These descriptors suggest a likely
differential diagnosis that includes acute cholecystitis. Antoniou et al. found acute cholecystitis as a negative
predictor for the completion of a SILC.
Antoniou SA, Pointner R, Granderath FA (2011) Single-incision laparoscopic cholecystectomy: a systematic
review. Surg Endosc 25(2):367-377.
b.
A 40 year old male, BMI 54 with a history of right upper quadrant pain 1 time in the past year, ultrasound with
gallstones and WBC 9.
The authors identify Antoniou et al. as a retrospective review that suggests an appropriate candidate for SILC. This
patient is morbidly obese with a BMI of 54. Antoniou et al. suggested that morbid obesity was indicative of a
more challenging procedure. In fact, the complication rate of SILC was higher in patients with the diagnosis of
obesity.
Antoniou SA, Pointner R, Granderath FA (2011) Single-incision laparoscopic cholecystectomy: a systematic
review. Surg Endosc 25(2):367-377.
c.
A 34 year old female, BMI 27 with a history of right upper quadrant pain 1 time in the past year, ultrasound with
gallstones and WBC 9.
The authors identify Antoniou et al. as a retrospective review that suggests an appropriate candidate for SILC.
Antoniou et al. found complication rates and operative time are higher in patients with age over 45 years and body
mass index (BMI) greater than 30. In addition the success with SILC in patients with acute cholecystitis was
significantly less (59.9 vs 93%). The patient in this vignette satisfies all of these descriptors.
Antoniou SA, Pointner R, Granderath FA (2011) Single-incision laparoscopic cholecystectomy: a systematic
review. Surg Endosc 25(2):367-377.
d.
A 72 year old male, BMI 27 with a history of right upper quadrant pain with multiple ER admissions requiring
antibiotics over the last year, ultrasound with gallstones and WBC 9.
The authors identify Antoniou et al. as a retrospective review that suggests an appropriate candidate for SILC. The
patient described in this vignette is older than the age group identified by Antoniou et al. as candidates for SILC. In
addition, this vignette depicts a patient with either repeated episodes of acute cholecystitis or chronic cholecystitis.
Either diagnosis is linked with a significantly reduced likelihood of successful completion of a SILC.
Antoniou SA, Pointner R, Granderath FA (2011) Single-incision laparoscopic cholecystectomy: a systematic
review. Surg Endosc 25(2):367-377.
2.
In the article presented by Phillips et al, which of the following complications were noted to be significant between the SILC
and four port cholecystectomy (4PLC)?
a.
Bile duct injury or bile leak
In the study presented by Phillips et al, neither group experienced a bile duct injury or bile leak. Therefore, the
occurrence rate was identical between groups.
b. Wound complications
In the study presented by Phillips et al, they found only a significant difference in wound complications in the SILC
group (4PLC 2.5% vs. SILC 10.3%, p<.047). While there was a slight trend seen in the SILC group toward
postoperative hernia recurrence it was not significant. Additionally other authors have similarly reported these
trends in wound infections and hernia occurrences.
Krajinovic K, Ickrath P, Germer CT, Reibetanz J (2011) Trocar-site hernia after single-port cholecystectomy: not
an exceptional complication? J Laparoendosc Adv Surg Tech A 21(10):919-21
c.
Retained choledocholithiasis
In the study presented by Phillips et al, each group reported a single patient with retained choledocholithiasis. As a
result, there was no statistical difference between the two groups (4PLC 1.3% vs. SILC 0.9%, p=1.0).
d.
Post operative hernia recurrence
In the study presented by Phillips et al, there wasn’t a statistical difference between the two groups with regard to
post-operative hernia formation (4PLC 1.3% vs. SILC 3.4%, p =0.65). The authors make an attempt to assess the
comparison differently in comparing the four incisions of the standard laparoscopic cholecystectomy (4PLC) to the
one incision of the SILC. In this respect, there is a potential significant difference of 0.03% per incision of the 4PLC
group and the 3.4% of the SILC group. However, this is likely not to hold clinical significance as the largest incisions
of both procedures is the extraction site incision. Most surgeons likely use the umbilical port as the extraction site
for 4PLC. Therefore, it would not be appropriate to take this distributed approach, and one should consider the
single incision of the SILC to the largest incision of the 4PLC.
3.
Phillips et al presented data in their single-blinded randomized controlled trial on pain after SILC vs 4PLC. Which of the
following factors were independent predictors of increased pain in this study?
a.
SILC
A univariate analysis of the data presented in this largest to date single-blinded randomized controlled trial showed
that female gender, younger age and SILC were independent predictors of increased pain. Other studies performed
have delivered both supporting and conflicting reports to these authors. In a double-blinded randomized controlled
trial by Tsimoyiannis et al in which they evaluated 40 patients they found that patients undergoing the SILC
technique had less pain at 12 and 24 hours after surgery. This is in contrast to the results of the current study
where there was a significant difference between the 2 groups in average pain that was noted in the SILC group at
3, 5, 7 and 30 days. The authors did however state that there was no difference in analgesia use between the 2
groups.
Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. (2010)
Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic
cholecystectomy: a randomized controlled trial. Surg Endosc 24:1,842–1,848.
b.
Male gender
Female gender was more likely to impact the pain scores following 4PLC or SILC in Phillips et al.
c.
4PLC
Performance of a standard four port laparoscopic cholecystectomy (4PLC) did not appear to lead to increased pain
in this study.
d.
Age > 65 years
Examination of the independent predictors for increased pain following cholecystectomy showed that younger age
was more likely a factor rather than older age.
4.
Using the data from this study and a review of the literature, the authors evaluated several factors associated with SILC vs
4PLC. Which of the following statements is NOT true?
a.
There is an increased overall cost of SILC vs 4PLC
The authors identified a study by Love et al, they did not find any significant difference in the cost (both equipment
and increased operative times) associated with SILC as compared to standard 4PLC. However, they did find that
those cases that were converted from SILC to a 4PLC did have a significant cost increase.
Love KM, Durham CA, Meara MP, Mays AC, Bower CE (2010) Single-incision laparoscopic cholecystectomy: a cost
comparison. Surg Endosc 25(5):1553–1558
b.
There is a similar safety profile of biliary complications
The author’s in this study found similar safety profiles of biliary complications, however they did note that this may
have been lower than expected given that they did exclude acute cholecystitis patients.
c.
There is an improved cosmesis as perceived by patients with SILC
In this study the authors found a statistically significant difference in perceived cosmesis at each time point
measured (1 week, 2 weeks, 1 month, 3 months and 1 year).
d.
There is an increased length of operative time with SILC
The authors noted that even with each of the surgeons included in the study that performed the procedures and
had performed at least 10 SILC procedures, the operative time was still statistically significantly higher in the SILC
group (57.2 minutes vs 45.2 minutes (p<0.0001)).
6. Please include 4 references (at least 1 per question above).
Antoniou SA, Pointner R, Granderath FA (2011) Single-incision laparoscopic cholecystectomy: a systematic review. Surg
Endosc 25(2):367-377.
Krajinovic K, Ickrath P, Germer CT, Reibetanz J (2011) Trocar-site hernia after single-port cholecystectomy: not an
exceptional complication? J Laparoendosc Adv Surg Tech A 21(10):919-21
Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. (2010) Different pain
scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a
randomized controlled trial. Surg Endosc 24:1,842–1,848.
Love KM, Durham CA, Meara MP, Mays AC, Bower CE (2010) Single-incision laparoscopic cholecystectomy: a cost
comparison. Surg Endosc 25(5):1553–1558
7. Please write a learning objective for this activity that describes a change in knowledge or competence.
At the conclusion of this activity, the learner will be able to make a more informed decision about the appropriate
candidate for single incision laparoscopic cholecystectomy.
____________________________________________________________________________
Please return to Yumi Hori – via email: yumi@sages.org
JC form version 8/22/2011