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RESEARCH LETTER
Table 1. Demographic and Clinical Characteristics and LC Outcomes
Among 3034 Patients (2005-2009 and 2010-2014)
PACIFIC COAST SURGICAL ASSOCIATION
Characteristic or Outcome Patients, No. (%)
Association of Fundamentals of Laparoscopic
Age, median (IQR), y 38 (28-51)
Surgery Certification With Outcomes
Sex
of Laparoscopic Cholecystectomy Performed
Male 623 (20.5)
by Surgical Residents
The Fundamentals of Laparoscopic Surgery (FLS) program was Female 2411 (79.5)

developed to assess the skills and knowledge essential to sur- Diabetes 183 (6.0)

geons as laparoscopy emerged, with the goal of improving qual- Preoperative diagnosisa
ity of care and safety, including reducing complication rates.1 Acute cholecystitis 1126 (37.1)
As laparoscopy has become mainstream, the ongoing value of Symptomatic cholelithiasis 1019 (33.6)
FLS certification as a high-stakes examination comes into ques- Gallstone pancreatitis 441 (14.5)
tion. We hypothesized that implementing mandatory FLS cer- Choledocholithiasis 421 (13.9)
tification would not appreciably alter resident performance of Chronic cholecystitis 69 (2.3)
or patient outcomes after laparoscopic cholecystectomy (LC). Cholangitis 48 (1.6)
Other 44 (1.5)
Methods | A retrospective review of all LCs (urgent, emergent, Intraoperative cholangiogram 1173 (38.7)
and elective) performed by junior surgical residents (post- Intraoperative complication 35 (1.2)
graduate year [PGY]1-3) with a senior resident (PGY4-5) teach- Bile duct injury 10 (0.3)
ing assistant at a university-affiliated public teaching hospi- CHD 4 (0.1)
tal in Torrance, California, was completed for 2 periods: before CBD 4 (0.1)
mandatory FLS certification (2005-2009) and after manda-
Combined CBD and CHD 2 (0.1)
tory FLS certification (2010-2014). An FLS certification at our
Bleeding 8 (0.3)
institution is obtained in the research year between PGY3 and
Right hepatic artery injury 2 (0.1)
PGY4. Outcome measures comprised a composite of all intra-
Liver laceration 5 (0.2)
operative complications, including intraoperative bile duct in-
Serosal colon injury 1 (0.03)
jury (BDI), surgery length, need for conversion to open cho-
Veress needle injury 2 (0.1)
lecystectomy or biliary bypass, overall hospital complications,
Cystic duct stump leak 7 (0.2)
length of stay, and 30-day readmission. The Los Angeles Bio-
Surgery length, median (IQR), h 1.6 (1.2-2.2)
medical Research Institute Institutional Review Board ap-
proved this study and waived the need for obtaining patient Conversion to open cholecystectomy 232 (7.6)

informed consent given the minimal risk to patients involved Biliary bypass performed 3 (0.1)

in this study. Overall hospital complicationsb 80 (2.6)
The before and after FLS certification categorical outcomes Hospital length of stay, median (IQR), d 4 (1-6)
were compared using 2-tailed χ2 or Fisher exact tests, whereas Mortality 0
the continuous variables were analyzed with the Wilcoxon rank 30-d Readmissions 72 (2.4)
sum test. For significantly associated variables in bivariate Abbreviations: CBD common bile duct; CHD common hepatic duct;
analyses, multivariable regression analyses were performed. Sta- IQR, interquartile range; LC, laparoscopic cholecystectomy.
tistical analyses were conducted from November 1, 2015, to a
Some cases were coded with multiple preoperative diagnoses.
September 30, 2017, using SAS, version 9.3 (SAS Institute Inc). b
Includes cerebrovascular accident, myocardial infarction, pulmonary
A 2-sided P < .05 was considered to be statistically significant. embolism, deep vein thrombosis, pneumonia, respiratory failure, bacteremia,
colitis, urinary retention, urinary tract infection, postoperative bleeding,
retained common bile duct stone, or pancreatitis.
Results | During the study period, 3034 LCs were performed. Acute
cholecystitis (1126, 37.1%) and symptomatic cholelithiasis (1019,
33.6%) were the most common preoperative diagnoses. Overall, gery (OR, 0.80; 95% CI, 0.61-1.05; P = .10) or biliary bypass (OR,
there were 35 intraoperative complications (1.2%), with 10 BDIs 2.43; 95% CI, 0.22-26.81; P = .45), or surgery length (OR, 0.30;
(0.3%) (Table 1). The results of bivariate analyses comparing data 95% CI, 0-0.50; P = .06); however, overall hospital complications
before and after the FLS certification requirement indicated no (OR, 1.59; 95% CI, 1.01-2.47; P = .04), hospital length of stay (OR,
significant difference with respect to intraoperative complica- 1.0; 95% CI, 0-2.0; P = .001), and 30-day readmissions (OR, 7.83;
tions (odds ratio [OR], 1.02; 95% CI, 0.53-1.97; P = .95), BDI (OR, 95% CI, 3.99-15.33; P < .001 were significantly different (Table 2).
0.52; 95% CI, 0.15-1.84; P = .53), need for conversion to open sur- The results of multivariable analyses indicated that patient age

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Letters

Table 2. Comparison of Baseline Demographic Characteristics and Outcomes
Before and After FLS Certification Required

Patients, No. (%)a
Characteristic or Outcome Before FLS After FLS OR (95% CI) P Value
Total No. of patients 1663 (54.8) 1371 (45.2) NA NA
Age, median (IQR), y 37 (28-49) 40 (29-53) 3 (1-4)b <.001
Female 1346 (80.9) 1065 (77.7) 0.82 (0.69-0.98) .03
Diabetes 68 (4.1) 115 (8.4) 2.15 (1.58-2.92) <.001
Preoperative diagnosisc
Acute cholecystitis 535 (32.2) 591 (43.1) 1.60 (1.38-1.85) <.001
Symptomatic 668 (40.2) 351 (25.6) 0.51 (0.44-0.60) <.001
cholelithiasis
Gallstone pancreatitis 242 (14.6) 199 (14.5) 0.99 (0.81-1.22) .98
Choledocholithiasis 173 (10.4) 248 (18.1) 1.90 (1.54-2.34) <.001
Chronic cholecystitis 17 (1.0) 52 (3.8) 3.81 (2.20-6.63) <.001
Cholangitis 22 (1.3) 26 (1.9) 1.44 (0.81-2.56) .21
Other 5 (0.3) 39 (2.8) 9.71 (3.82-24.70) <.001
Intraoperative 722 (43.4) 451 (32.9) 0.64 (0.55-0.74) <.001
cholangiogram
Intraoperative 19 (1.1) 16 (1.2) 1.02 (0.53-1.97) .95
complication
Bile duct injury 7 (0.4) 3 (0.2) 0.52 (0.15-1.84) .53
Surgery length, median 1.55 (1.11-2.12) 1.60 (1.17-2.17) 0.30 (0-0.50)b .06
(IQR), h
Abbreviations: FLS, Fundamentals of
Conversion to open 139 (8.4) 93 (6.8) 0.80 (0.61-1.05) .10
Laparoscopic Surgery;
cholecystectomy
IQR, interquartile range; NA, not
Biliary bypass performed 1 (0.1) 2 (0.2) 2.43 (0.22-26.81) .45
applicable; OR, odds ratio.
Overall hospital 35 (2.1) 45 (3.3) 1.59 (1.01-2.47) .04 a
Categorical variables expressed as
complication
No. (%); continuous variables, as
Hospital length of stay, 3 (0-6) 4 (2-6) 1 (0-2)b .001 median (IQR).
median (IQR), d
b
Median difference (95% CI).
Mortality 0 0 NA NA
c
Some cases were coded with
30-d Readmission 10 (0.6) 62 (4.5) 7.83 (3.99-15.33) <.001
multiple preoperative diagnoses.

was the only factor independently associated with intraopera- tification positively influences rates of intraoperative compli-
tive complications (OR, 1.03; 95% CI, 1.01-1.06; P = .006); no fac- cations, one of the stated certification goals.
tor was associated with longer length of stay, and both increas- This study is limited by its retrospective design and poten-
ing patient age (OR, 1.03; 95% CI, 1.01-1.04; P < .001) and after tial selection bias given that it is a single-institution study. In ad-
mandatory FLS certification (OR, 7.6; 95% CI, 3.8-15.0; P < .001) dition, the residents at our institution participate very early in
were significantly associated with readmission. hands-on training in laparoscopic surgery; thus, it is possible that
owing to this extensive early exposure, the operative outcomes
Discussion | In this study, after implementation of mandatory FLS at our institution were not substantially influenced by the imple-
certification, we found no appreciable improvement in outcomes mentation of mandatory FLS certification.
of LCs performed by residents as measured by several outcome Today’s residents face greater hurdles to achieve board cer-
measures, including intraoperative complications, surgery length, tification, including mounting student debt, longer training pe-
and the need for conversion to open cholecystectomy. riods, and a growing list of mandatory certifications.5 The first-
A recent systematic review2 finding limited data to sup- time pass rate for FLS is 96%,6 suggesting a low discriminating
port the validity of FLS manual skill examination tasks or the value. There does not appear to be evidence that mandatory
scoring method suggested that demonstrating differences in FLS certification has improved LC outcomes. As such, one must
scores between novices and experts does little to confirm con- reassess the value of continuing FLS in its current format as a
tent validity. In a review of 53 632 LCs from an insurance da- high-stakes examination.
tabase, Schwaitzberg et al3 reported that FLS-certified sur-
geons had, counterintuitively, a higher rate of BDI compared Emily D. Dubina, MD
with non-FLS−certified surgeons (0.47% vs 0.14%, P = .001). Xuan-Binh D. Pham, MD
A 2003 study4 determined that 97% of BDIs during LC were Alexander C. Schwed, MD
attributable to errors in perception, judgment, and knowl- Hoover Wu, MD
edge, but the FLS examination addresses only basic laparo- Imani McElroy, MD
scopic skills.1 When combined with the results of the present Amy H. Kaji, MD
study, those study results bring into question whether FLS cer- Christian de Virgilio, MD

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Author Affiliations: Department of Surgery, Harbor-UCLA Medical Center, Department of Surgery, Harbor-UCLA Medical Center), contributed to the
Torrance, California (Dubina, Pham, Schwed, Wu, McElroy, de Virgilio); acquisition, analysis, and interpretation of the data, and Dennis Kim, MD
Department of Surgery, University of Chicago Medical Center, Chicago, Illinois (Department of Surgery, Harbor-UCLA Medical Center), provided critical
(Wu); Department of Surgery, Massachusetts General Hospital, Boston revision of the manuscript; they received no compensation for their work.
(McElroy); Department of Emergency Medicine, Harbor-UCLA Medical Center, 1. Fundamentals of Laparoscopic Surgery. Fundamentals of Laparoscopic
Torrance, California (Kaji); Los Angeles Biomedical Research Institute, Surgery program description. https://www.flsprogram.org/index/fls-program
Harbor-UCLA Medical Center, Torrance, California (Kaji, de Virgilio). -description/. Accessed December 7, 2017.
Accepted for Publication: May 28, 2018. 2. Zendejas B, Ruparel RK, Cook DA. Validity evidence for the Fundamentals of
Corresponding Author: Christian de Virgilio, MD, Department of Surgery, Laparoscopic Surgery (FLS) program as an assessment tool: a systematic
Harbor-UCLA Medical Center, 1000 W Carson St, PO Box 25, Torrance, CA review. Surg Endosc. 2016;30(2):512-520. doi:10.1007/s00464-015-4233-7
90502 (cdevirgilio@labiomed.org). 3. Schwaitzberg SD, Scott DJ, Jones DB, et al. Threefold increased bile duct
Published Online: August 29, 2018. doi:10.1001/jamasurg.2018.2705 injury rate is associated with less surgeon experience in an insurance claims
Author Contributions: Drs Pham and Kaji had full access to all of the data in the database: more rigorous training in biliary surgery may be needed. Surg Endosc.
study and take responsibility for the integrity of the data and the accuracy of 2014;28(11):3068-3073. doi:10.1007/s00464-014-3580-0
the data analysis. 4. Way LW, Stewart L, Gantert W, et al. Causes and prevention of laparoscopic
Concept and design: Pham, de Virgilio. bile duct injuries: analysis of 252 cases from a human factors and cognitive
Acquisition, analysis, or interpretation of data: All authors. psychology perspective. Ann Surg. 2003;237(4):460-469. doi:10.1097/01.SLA
Drafting of the manuscript: Dubina, Schwed. .0000060680.92690.E9
Critical revision of the manuscript for important intellectual content: All authors. 5. The American Board of Surgery. Training requirements. http://www
Statistical analysis: Pham, Schwed, Wu, McElroy, Kaji. .absurgery.org/default.jsp?certgsqe_training. Published 2017. Accessed January
Administrative, technical, or material support: de Virgilio. 19, 2018.
Conflict of Interest Disclosures: None reported. 6. Bilgic E, Kaneva P, Okrainec A, Ritter EM, Schwaitzberg SD, Vassiliou MC.
Meeting Presentation: This paper was presented in part at the 89th Annual Trends in the Fundamentals of Laparoscopic Surgery (FLS) certification exam
Meeting of the Pacific Coast Surgical Association; February 18, 2018; over the past 9 years. Surg Endosc. 2018;32(4):2101-2105. doi:10.1007/s00464
Napa, California. -017-5907-0
Additional Contributions: Jessica Keeley, MD (Department of Surgery,
Los Angeles County-University of Southern California Medical Center, formerly

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