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Sartorius transposition during inguinal lymphadenectomy for melanoma. Bartlett EK, Meise C, Bansal N, Fischer JP, Low DW, Czerniecki BJ, Roses RE, Fraker DL, Kelz RR, Karakousis GC. J Surg Res. 2013 Sep;184(1):209‐15. doi: 10.1016/j.jss.2013.04.033. Epub 2013 May 8 The original publication is available at the JSR website at: http://www.journalofsurgicalresearch.com/home
Sartorius Transposition During Inguinal Lymphadenectomy For Melanoma
Edmund K. Bartlett1, MD, Chelsey Meise1, BA, Neha Bansal1, BA, John P. Fischer1, MD, David W. Low1, MD, Brian J. Czerniecki1, MD, PhD, Robert E. Roses1, MD, Douglas L. Fraker1, MD, Rachel R. Kelz1, MD, Giorgos C. Karakousis1, MD.
1 Department of Surgery, University of Pennsylvania, Philadelphia, PA
Acknowledgement: The American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors.
Running Title: Sartorius Transposition for Inguinal Lymphadenectomy
Manuscript Category: Oncology/Endocrine
Corresponding Author: Edmund Bartlett Hospital of the University of Pennsylvania 3400 Spruce St., 4 Maloney, DSE Philadelphia, PA 19147 [email protected] Phone: 215‐738‐0380 Fax: 215‐662‐7476
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Abstract Introduction Inguinal lymph node dissection (ILND) for melanoma has been associated with high rates of wound complication (WC). Sartorius transposition (ST) is a technique that has been proposed to minimize morbidity. We report the frequency of utilization of ST and associated clinical outcomes in a national sample. Materials and Methods Patients undergoing ILND for melanoma were identified in the ACS NSQIP Participant Use File (2005‐2011). ST status was determined. Univariate logistic regression analyses were performed. Propensity score matching was utilized to control for operative time. Conditional logistic regression was used to determine the likelihood of a WC following ST in the matched cohort. Results Of the 381 patients identified, 13% had a WC. By univariate analysis, increasing BMI (p=0.006), diabetes (p=0.02), and longer operative time (p=0.005) were associated with WC. Sixty‐three patients received a prophylactic ST (16.5%). ST use was significantly associated with deep nodal dissection (p=0.03) and increased operative time (p<0.0001), but not with any preoperative risk factors. WC rates were similar between ST and non‐ST patients (10% versus 14%, p=.39). In the multivariate analysis of patients matched for operative time, ST was the only factor significantly associated with lower WC rate. The WC rate was 23% in non‐ST compared to 8% in ST patients (p=0.05). Conclusion Nationally, ST is used infrequently at time of ILND. Moreover, patients undergoing ST do not appear to be selected based on patient factors associated with increased risk of WC. Risk factors for wound complication should be considered in the selective use of ST. Key words Sartorius transposition flap Inguinal lymph node dissection Melanoma Wound complication
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Introduction
The incidence of melanoma is increasing more rapidly than any other cancer in the United States
with approximately 76,000 new cases predicted in 2012.1, 2 The majority (84%) of melanoma patients
present without evidence of distant metastatic disease.3 For these patients, regional lymph node
involvement is the single most predictive factor for survival.4, 5 The wide‐spread adoption of sentinel
lymph node (SLN) biopsy has resulted in lymph node dissection (LND) being reserved for the subset of
patients that present with clinically palpable lymphadenopathy or nodal involvement by SLN biopsy.
Approximately 9% of all patients present with isolated nodal metastases, one‐third of whom have
melanomas of the lower extremity and would be eligible for an inguinal LND.2, 6 The benefit to
completion LND after SLN biopsy remains controversial and is the subject of the Multicenter Selective
Lymphadenectomy Trial II currently underway.7 Nevertheless, therapeutic lymphadenectomy remains
the standard of care for patients with nodal involvement,8 as it has been associated with lower local
recurrence rates and potentially improved survival.9, 10
Bilimoria et al. studied the National Cancer Database from 2004‐2005 and found that of the
2942 patients nationally with positive SLNs only 50% underwent completion lymphadenectomy.11
Elderly patients and those with lower extremity melanomas were significantly less likely to undergo LND,
and when performed, LNDs were more likely to be inadequate (≤10 lymph nodes removed) in these
patients. Although the study design could not determine reasons for the poor adherence to
recommended care, avoidance of the morbidity associated with LND clearly contributes to patients’ and
likely surgeons’ concerns.
The morbidity associated with LND, particularly inguinal LND, is significant. For inguinal LND,
multiple series have reported high rates of surgical site infection (16‐65%),12‐21 wound breakdown (7‐
53%),12, 13, 15‐17, 20 seroma (2‐46%),12, 13, 15‐17, 20 and lymphedema (27‐64%).12, 13, 15‐17, 19, 20 These reports
have identified a number of patient risk factors associated with wound complications including: male
4
gender,12 older age,12, 14, 18, BMI,12‐14, 18, 19 smoking,12, 14 diabetes,14 and nodal status.12, 19 The most
devastating of these complications is wound breakdown leading to the exposure of and potential injury
to the femoral vessels. Although the incidence of femoral vessel injury has not been defined, 0‐16% of
patients return to the operating room after inguinal LND for wound debridement, muscle flap, or skin
graft to avoid this complication.12, 22, 23 Multiple techniques have been proposed to try prophylactically to
mitigate these complications, including ST flap, saphenous vein preservation, omental flap, fascial
preservation, and prolonged post‐operative antibiotics, with varying rates of success.24
Here we study the use of the sartorius transposition (ST) flap in a national cohort. Figure 1. The
theoretical benefit of ST is in the tissue coverage of the femoral vessels, preventing the most
devastating complications of wound dehiscence. The additional vascular tissue may have a role in
preventing superficial infection, but the creation of thin skin flaps has traditionally been implicated as a
significant contributor to superficial ischemia and subsequent infection. The use of ST is variably
reported in series on LNDs for melanoma. No benefit was found in one of the most recent large
retrospective series specifically in melanoma.19 A single randomized trial has been performed in the
gynecology literature in 61 patients with squamous cell cancer of the vulva.25 This study found no
decrease in wound complications associated with the use of ST. These series were likely underpowered
to detect any benefit that may occur, and the potential severity associated with exposed femoral vessels
is such that many high‐volume centers continue to routinely perform ST prophylactically at the time of
LND.26 Here we query the National Surgical Quality Improvement Program (ACS NSQIP) database to
assess the utilization of ST in a national sample of patients to determine the patient characteristics and
postoperative outcomes associated with its use.
Methods
5
Patients were selected for inclusion in the study if they 1) were enrolled in The American College
of Surgeons National Surgical Quality Improvement Program Participant Use File (ACS NSQIP PUF) (FY
2005‐2011), 2) presented with a diagnosis of melanoma as determined by the International
Classification of Diseases (ICD‐9) Diagnosis Codes: 172 and 1720‐1729 and 3) underwent inguinal LND
defined using Current Procedural Terminology (CPT) codes: 38760 (superficial node dissection) or 38765
(superficial and deep node dissection). Patients were classified as receiving a prophylactic ST (CPT
15738) if a ST was performed during the same anesthetic as the LND. For the purposes of this study,
only prophylactic ST was considered in the analysis.
The ACS NSQIP PUF (FY 2005‐2011) was utilized. The ACS NSQIP database captures both
inpatient and outpatient complications for 30 days after operation. The Participant Use File is available
to organizations that participate in the ACS NSQIP for use in clinical and research projects. The dataset
has been widely used and is recognized as a robust clinical registry with reliable and valid data.27‐29
The primary outcome studied was wound complication defined as wound dehiscence
(disruption of the fascia in the surgical wound) or surgical site infection (SSI). SSI was defined using the
three variables reported in the ACS NSQIP PUF: superficial skin infection (involving only skin and
subcutaneous tissue), deep surgical site infection (involving muscle or fascia), and organ space infection
(infection of areas affected by the operation but deep to the fascia).30 Seroma and lymphedema are not
captured in the ACS NSQIP data. Other postoperative complications examined included urinary tract
infection, deep venous thrombosis, pulmonary embolism, blood transfusion requirement, pneumonia,
return to operating room, myocardial infarction, and death. Preoperative and intraoperative dependent
variables included: age, gender, race (white or other), body mass index (BMI), smoking, diabetes, steroid
use, history of bleeding disorder, chronic obstructive pulmonary disease (COPD), congestive heart failure
(CHF), radiation within 90 days, chemotherapy within 30 days, preoperative albumin (g/dl), and
operative time (minutes).
6
Descriptive statistics were examined. Univariate analysis was performed using the Student’s t‐
test, Fisher’s exact and Chi square tests, as appropriate. Propensity score matching to control for the
effects of factors identified as significantly associated with both the use of ST and wound complication
was used. One to one matching was performed using a caliper of .05 on the estimated propensity score.
Using the matched cohort, a conditional logistic regression model was developed to evaluate the
association between ST and wound complication with adjustment for factors associated (p<0.1) with ST
or wound complication by univariate analysis. Use of an interaction term was employed to account for
effects modification.
A p‐value of less than 0.05 was considered statistically significant. All data was transferred into
STATA format using Stat/Transfer Version 11.0 statistical program and analysis was performed using
STATA 12.0/IC statistical software.31‐33 This study was reviewed by the University of Pennsylvania
Institutional Review Board and deemed exempt from approval.
Results
Three hundred and eighty‐one patients were identified as having undergone inguinal LND for
melanoma from 2005‐2011 in the ACS NSQIP database. Mean age of the patients was 57 years. Most
were female (58%) and nearly all were white (91%). Smoking (19%) and diabetes (8%) were the most
frequently observed preoperative comorbidities. Table 1.
Complications of interest included SSI, wound dehiscence, and any wound complication. Forty‐
seven patients developed SSI (12%), 8 developed wound dehiscence (2%). Six patients experienced both
a SSI and dehiscence, so a total of 49 patients (13%) experienced a wound complication. The average
time to the development of SSI and dehiscence was 15 and 16 days, respectively. Return to the
operating room was the most frequent other complication (7%). The indication was not specified, but
could include both hemorrhage and infection. Other complications were infrequently observed: blood
7
transfusion requirement (2%), urinary tract infection (1%), deep venous thrombosis (1%), pulmonary
embolism (1%), myocardial infarction (<1%), and death (1%). Table 2.
By univariate analysis, increasing body mass index (BMI, p=0.004), smoking (p=0.05), diabetes
(p=0.01), deep groin dissection (p=0.03), and longer operative time (p<0.001) were significantly
associated with SSI. No factor was significantly associated with wound dehiscence. Increasing BMI
(p=0.006), diabetes (p=0.02) and longer operative time (p=0.005) were associated with any wound
complication by univariate analysis. The respective rates of wound complications in the various risk
factor subgroups were as follows: age>64 (15%), BMI>34 (25%), diabetes (27%), current smoker (19%),
deep groin dissection (20%), operative time>150 minutes (23%).
In all patients undergoing inguinal LND, 63 patients received a prophylactic ST (16.5%). Patients
undergoing ST were not significantly different by any patient characteristics from those patients not
undergoing ST. Table 3. ST, however, was performed in 25% of deep groin dissections compared to 15%
of superficial (p=0.03), and was associated with significantly longer operative times (mean of 194
minutes versus 128 minutes, p<0.0001). Prolonged operative times were observed in ST patients
compared to non‐ST patients for both deep (mean of 228 versus 168 minutes) and superficial (mean of
181 versus 120 minutes) groin dissections. In patients with 2 or more risk factors significant for wound
infection by univariate analysis (BMI, diabetes, smoking), ST was used in 8%; in patients with the two risk
factors associated with any wound complication (BMI and diabetes) the rate of flap use was 0%.
The rates of wound complications in patients with and without ST were compared. Overall, a
wound complication occurred in 10% of patients with ST and in 14% of patients without ST (p=0.39).
Because prolonged operative time was associated with an increased rate of wound complication as well
as receipt of a ST, 52 patients receiving ST were matched 1:1 by operative time and compared to those
not receiving ST. Mean operative time in the matched groups was 171 minutes. The two groups did not
significantly differ with respect to any of the preoperative risk factors, but there was a trend toward
8
higher BMI in the non‐ST group. Table 4. In the conditional logistic regression model of the matched
cohort, patients receiving ST were significantly less likely to experience a SSI (OR=0.21, CI=0.05‐0.82,
Table 5.) or any wound complication (OR=0.28, CI=0.08‐0.98, Table 6.) than those in the non‐ST group.
Discussion
In this study, we describe the wound complications and utilization of ST in patients undergoing
inguinal LND for melanoma in the ACS NSQIP database. We find a low rate of wound complications
(13%) as well as low utilization of prophylactic ST (16.5%) in patients undergoing inguinal LND. Patients
receiving ST have similar preoperative characteristics to those not receiving it. ST use was not associated
with lower wound complication rates but was associated with longer operative time which was, in turn,
predictive of an increased wound complication rate. When matched for similar operative times,
patients undergoing ST were significantly less likely to experience a wound complication (8%) compared
to patients not receiving a ST (23%).
The comorbidities associated with SSI and wound dehiscence were similar, although the low
number of dehiscences made statistical conclusions difficult. Risk factors such as BMI, smoking, and
diabetes are well described as being associated with wound complications after inguinal LND.12‐14, 18, 19
Operative time has been associated with increased wound complications in multiple operations,34, 35 but
not to our knowledge specifically after inguinal LND.
More surprising is the low rate of wound complications following inguinal lymphadenectomy
observed in the ACS NSQIP database. In large surgical series, wound complication rates have ranged
from 16‐65%, with most reporting rates over 30%.12‐21 The variability in wound complication rates
among the current study and previously published reports could be explained, in part, by differences in
definitions of wound complications between ACS NSQIP and many of the previously reported series; ACS
NSQIP definitions are strict and may exclude many of the minor infections seen in other series.
9
Particularly, many series include seroma in the overall wound complication analysis, and this was not
evaluable in ACS NSQIP. Moreover, a series comparing rates of wound complication in the SLN era to
LNDs performed for clinical disease found that LND after SLN biopsy had significantly lower rates of
wound complication (28% versus 14%).19 Although the indication for the procedure is unknown in this
report, the period of data (2005‐2011) suggests that many of the patients in the current study likely
underwent completion lymphadenectomy after SLN biopsy.
Additionally, the low rate of wound complication in this report may reflect the high degree of
patient selection occurring nationally compared to single large‐volume institutions. In one of the few
prospective analyses of wound complications after LND from Memorial Sloan Kettering Cancer Center,
patients were found to have a 64% rate of wound complication after inguinal LND. In that study, 42% of
patients had two or more risk factors for wound complications; whereas in the current study, only 17%
of patients had two or more similar comorbidities. This may be explained by patient selection for
inguinal LND and is consistent with a recently published report that rates of completion LND for
melanoma after positive SLN biopsy are low nationally, particularly in patients at increased risk for
complication.11
Given the concern for wound complication in patients undergoing inguinal lymphadenectomy,
the infrequent utilization of ST is somewhat surprising. More so, is the lack of association of ST
utilization with known patient risk factors for wound complications, particularly those high risk patients
with multiple risk factors. This suggests that the decision for the use (or not) of ST is made without
significant regard to underlying patient characteristics. One possibility to explain these results is that
certain surgeons may routinely perform ST while others rarely if ever do. Another possibility is that the
decision to use ST may be based more on tumor factors and less on patient factors. The longer operative
times associated with ST are not surprising given that it represents an additional procedure, but the
mean of an additional 66 minutes seems beyond what would be expected for performance of the ST
10
alone. Longer operative time may therefore be a surrogate for more extensive or bulky
lymphadenopathy (a factor not directly captured by the ACS NSQIP database). Patients with more
extensive nodal involvement require additional dissection, often thinner skin flaps, and have been found
to have increased rates of wound complications.12, 19 In fact, use of ST was more commonly performed in
deep groin dissections, but surprisingly the prolonged operative times were still observed in ST patients
regardless of the extent of groin dissection. Other factors leading to increased operative times may
include the thoroughness of dissection and surgeon experience which may be different between
patients who receive ST and those who do not. Finally, there may be additional factors, either patient or
procedure related that are not well captured in the ACS NSQIP data which could contribute to longer
operative times.
This study has several limitations given the retrospective nature of the data. The analysis is
limited to factors captured in the ACS NSQIP data, which does not include any melanoma‐specific
information. This is particularly important, since nodal status has been previously associated with rates
of wound complication.12, 19 Other factors which are not captured in this data, but may contribute to
wound complication rates include the use of perioperative antibiotics and surgeon volume and
experience. While ST was found to be associated with decreased wound complications in the matched
cohort, these factors as well as other unidentified factors may influence the observed association.
In the current study we found no difference in wound complication rates between patients
undergoing ST and those not. However, when accounting for operative time, patients undergoing ST
had a significantly lower wound complication rate compared to the non‐ST group (23% versus 8%). The
precise clinical significance of this is unclear, as performance of ST itself requires some additional
operative time; therefore, the matched ST group may have had more favorable tumor biology (with
easier dissection) when compared to the non‐ST group of similar operative time. However, despite
significantly longer operative times, the low rate (10%) of wound complication associated with ST in the
11
overall cohort does suggest that ST use warrants consideration. If ST is to be used selectively, particular
consideration should be given to patients with known increased risk factors for wound infection,
including elevated BMI, history of smoking, diabetes, and those requiring deep groin dissection. One
would postulate that any potential value of ST would be more evident and therefore its use more
justified in this patient population which is at increased risk for post‐procedural wound complications.
In conclusion, ST is used infrequently at a national level, and decision for its use does not appear
to be driven by underlying patient risk factors associated with wound complications. Consideration of
ST, particularly in high risk patients, may help to mitigate the impact of wound complications in these
patients.
12
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Figure Legend: Figure 1. Sartorius Transposition Flap. A) Anatomy of skeletonized femoral vessels after lymphadenectomy. B) The sartorius muscle is detached from its proximal insertion and rotated medially to cover the vessels prior to closure of the incision.
16
Table 1 – The Preoperative and Intraoperative Factors Associated with Wound Complication
All Patients N (%)
Wound Infection
N (%)
Any Wound Complication
N (%)
No Yes p‐value No Yes p‐value
Age Mean (SD) 56.5 ( 16) 56.0 (16)
60.2 (13) 0.08
55.9 (16)
60.4 (12) 0.06
Female Gender 221 (58) 195 (58)
26 (57) 0.66
193 (58)
28 (57) 0.86
White Race 86 (91) 73 (91)
13 (93) 0.84
72 (91)
14 (93) 0.78
Body Mass Index Mean (SD) 28.7 (6)
28.4 (6)
31.2 (7) 0.004
28.4 (6)
31.1 (7) 0.006
Current Smoker 74 (19) 60 (18)
14 (30) 0.05
60 (18)
14 (29) 0.08
Diabetes 30 (8) 22 (7)
8 (17) 0.01
22 (7)
8 (16) 0.02
Steroid Use 7 (2) 6 (2)
1 (2) 0.87
6 (2)
1 (2) 0.91
History of Bleeding Disorder 13 (3)
12 (4)
1 (2) 0.60
12 (4)
1 (2) 0.57
History of COPD 4 (1) 2 (1)
2 (4) 0.08
2 (1)
2 (4) 0.08
History of CHF 0 (0) 0 0 ‐ 0 0 ‐ Radiation Within 90 Days 1 (<1)
1 (1)
0 (0) 0.87
1 (<1)
0 (0) 0.86
Chemotherapy Within 30 Days 8 (2)
8 (3)
0 (0) 0.60
7 (2)
1 (2) 0.92
Preoperative Albumin Mean (SD) 4.18 (.5)
4.2 (.4)
4.1 (.32) 0.21
4.2 (.44)
4.1 (.33) 0.12
Deep Groin Dissection 71 (19)
57 (17)
14 (30) 0.04
57 (17)
14 (29) 0.06
Operative Time (min) Mean (SD) 139 (88)
133 (85)
179 (98) <0.001
133 (85)
179 (98) 0.005
Sartorius Transposition 63 (17)
58 (17)
5 (11) 0.29
57 (17)
6 (12) 0.39
17
Table 2 ‐ Postoperative Complications in Patients Undergoing Inguinal LND Post‐Operative Complication N (%)
Surgical Site Infection 47 (12)Wound Dehiscence 8 (2)Urinary Tract Infection 3 (1)Deep Venous Thrombosis 3 (1)Pulmonary Embolism 2 (1)Blood Transfusion Requirement 9 (2)Pneumonia 0 (0)Return to Operating Room 27 (7)Myocardial Infarction 1 (<1)Death 3 (1)
Table 3 ‐ Factors Associated with Receiving a Sartorius Transposition
No ST N=318
ST N=63
p‐value N (%) N (%)
Age Mean (SD) 56.6 (16) 56.2 (16) 0.88 Female Gender 180 (57) 41 (65) 0.23 White Race 76 (90) 10 (100) 0.59 Body Mass Index Mean (SD) 28.8 (7) 28.4 (5) 0.64 Current Smoker 64 (20) 10 (16) 0.43 Diabetes 26 (8) 4 (6) 0.80 Steroid Use 6 (2) 1 (2) 0.87 Chemotherapy Within 30 Days 8 (3) 0 (0) 0.37 Preoperative Albumin Mean (SD) 4.2 (.4) 4.3 (.4) 0.21 Deep Groin Dissection 53 (17) 18 (29) 0.03 Operative Time (min) Mean (SD) 128 (86) 194 (81) <0.0001
18
Table 4 – Comparison of Factors Associated with Wound Complication in the Matched Cohort
No ST group N=52
ST group N=52
p‐valueN (%) N (%) Operative Time, Mean (SD) 170.8 (57) 170.83 (57) 0.997
Age, Mean (SD) 56.3 (16) 56.2 (16) 0.988 Body Mass Index, Mean (SD) 31.1 (8) 28.4 (5) 0.051
Current Smoker 14 (27) 7 (13) 0.087
Diabetes 4 (8) 4 (8) 1.00
History of COPD 0 (0) 0 (0) 1.00
Deep Group Dissection 15 (29) 13 (25) 0.66 Table 5 – Association of ST with Surgical Site Infection in Patients Matched for Operative Time
SSI in ST Patients, N(%)
SSI in non‐ST patients, N(%) p‐value
Univariate Analysis 12 (23) 3 (6) 0.02
Multivariate Model
OR
95% Confidence Interval
Low High Sartorius Transposition 0.205 0.051 0.82 Age 1.03 0.991 1.081 Body Mass Index* 1.02 0.965 1.079 Diabetes* ‐‐ ‐‐ ‐‐ Current Smoker 1.47 0.333 6.493 History of COPD** ‐‐ ‐‐ ‐‐ Deep Group Dissection 2.43 0.671 8.804 *An interaction term was employed as BMI and diabetes were found to be collinear. The results for the interaction term are reported. **There were no COPD patients in the matched cohort. OR (odds ratio)
19
Table 6 – Association of ST with Any Wound Complication in Patients Matched for Operative Time
SSI in ST Patients, N(%)
SSI in non‐ST patients, N(%) p‐value
Univariate Analysis 12 (23) 4 (8) 0.05
Multivariate Model
OR
95% Confidence Interval
Low High Sartorius Transposition 0.28 0.081 0.984 Age 1.03 0.990 1.073 Body Mass Index* 1.02 0.963 1.074 Diabetes* ‐‐ ‐‐ ‐‐ Current Smoker 1.35 0.320 5.677 History of COPD** ‐‐ ‐‐ ‐‐ Deep Group Dissection 2.04 0.593 7.013 *An interaction term was employed as BMI and diabetes were found to be collinear. The results for the interaction term are reported. **There were no COPD patients in the matched cohort. OR (odds ratio)