Original Research—Head and Neck Surgery Oropharyngeal Contamination Predisposes to Complications after Neck Dissection: An Analysis of 9462 Patients Otolaryngology– Head and Neck Surgery 2015, Vol. 153(1) 71–78 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599815581808 http://otojournal.org Umang Jain1, Jessica Somerville, MD2, Sujata Saha1, Nicholas James Hackett1, Jon P. Ver Halen, MD3, Anuja K. Antony, MD, MPH4, and Sandeep Samant, MD2 No sponsorships or competing interests have been disclosed for this article. Abstract Objective. While neck dissection is important in the treatment of head and neck cancer, there is a paucity of studies evaluating outcomes. We sought to compare preoperative variables and outcomes between clean and contaminated neck dissections, using the 2006-2011 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) data sets. Study Design. Retrospective review of prospectively maintained database. Setting. Multicenter (university hospitals; tertiary referral centers). Subjects and Methods. A retrospective review was performed of the NSQIP database to identify patients undergoing neck dissection in clean vs oropharyngeal contaminated cases. Clinical factors, comorbidities, epidemiologic factors, and procedural characteristics were analyzed to identify factors associated with 30-day postoperative adverse events, including medical and surgical complications, unplanned reoperation, and mortality. Bivariate and multivariable analyses were performed for the outcome of one or more adverse events. Results. In total, 8890 patients had clean neck dissections, while 572 patients had neck wound contamination with oropharyngeal flora. On multivariable regression analysis, oropharyngeal contamination was a significant risk factor for surgical complications (odds ratio [OR], 3.42; 95% confidence interval [CI], 1.96-5.96; P \ .001). However, medical complications and mortality were not significantly different between the 2 cohorts. This finding persisted after subgroup analysis, with removal of all thyroidectomy patients from analysis (OR, 2.33; 95% CI, 1.25-4.36; P = .008). Conclusion. Using the ACS-NSQIP data set, this study found an increased risk of surgical complications in the setting of contaminated neck dissections. These data should be used for patient risk stratification, informed consent, and to guide further research. Keywords neck dissection, clean cases, contaminated cases, NSQIP, outcomes, mortality Received September 17, 2014; revised March 11, 2015; accepted March 24, 2015. S urgical neck dissection is used as a diagnostic, staging, and therapeutic modality and is thus an essential tool for the head and neck oncologic surgeon. To date, studies evaluating neck dissection have only been in conjunction with other procedures, are limited to single-surgeon or single-institution experiences, lack current review, and do not use large database analyses.1-5 The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) is the premier tool for population-based analyses of critical health care issues, including registry-based trials, risk adjustment, surgical outcomes, and cost.6,7 The current study revisits the topic of wound contamination by oral and pharyngeal secretions (referred to as oropharyngeal contamination in this article) after neck dissection. Prior single-institution studies have demonstrated a significant increase in postoperative wound infection in neck dissections with concomitant entry into the oropharyngeal and/or respiratory tracts.8-10 While it is generally accepted that concomitant resections on the oropharyngeal 1 Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA 2 Department of Otolaryngology–Head and Neck Surgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA 3 Department of Plastic, Reconstructive, and Hand Surgery, Baptist Cancer Center–Vanderbilt Ingram Cancer Center, Memphis, Tennessee, USA 4 Division of Plastic and Reconstructive Surgery, University of Illinois at Chicago, Chicago, Illinois, USA This article was presented at the 2014 AAO-HNSF Annual Meeting & OTO EXPO; September 21-24, 2014; Orlando, Florida. Corresponding Author: Jon P. Ver Halen, MD, Department of Plastic, Reconstructive, and Hand Surgery, Baptist Cancer Center, 3268 Duke Circle, Germantown, TN 38139, USA. Email: [email protected] Downloaded from oto.sagepub.com at SOCIEDADE BRASILEIRA DE CIRUR on July 2, 2015 72 Otolaryngology–Head and Neck Surgery 153(1) tract have the added risk of increasing surgical infections, verification of this risk on a large scale across institutions, its impact on global postsurgical outcomes, and the influence of further contributing factors have not been performed. unplanned readmission (only available for procedures in 2011), or mortality. The cohort of patients experiencing complications consisted of any patient who had 1 or more adverse event within 30 days of the procedure. Materials and Methods Adjusted Risk Factors All study aspects were reviewed and approved by the institutional review boards of all authors’ institutions (Northwestern University, University of Tennessee–Memphis, Baptist Cancer Center, and University of Illinois–Chicago). A retrospective analysis was performed on data collected from the 2006-2011 NSQIP participant use files. The data collection methods for NSQIP have been previously described.11-13 Briefly, 240 variables, including patient demographics, comorbidities, perioperative details, and 30-day risk-adjusted postoperative outcomes, are prospectively collected for each patient at participating institutions within the United States. To ensure accuracy, certified nurse reviewers are rigorously trained to collect patient information according to standardized definitions, with the data undergoing regular audit. The eligible study population included all patients undergoing inpatient and outpatient surgery at any of the over 400 NSQIP participant hospitals, which included approximately 2 million patients as of December 31, 2012. This included a cross section of all patients undergoing neck dissection in North America, including rural and urban hospitals, and teaching and nonteaching hospitals. For this study, NSQIP was first queried to identify all neck dissection procedures with Current Procedural Terminology (CPT) codes in head and neck extirpation procedures, without involvement of the oropharyngeal tract (ie, ‘‘clean’’ cases). This included primary, other, or concomitant codes, including 60252 (thyroidectomy with limited central neck dissection), 60254 (thyroidectomy with lymph node dissection [LND]), 38700 (suprahyoid LND), 38724 (modified radical neck dissection [MRND]), 38720 (radical neck dissection [RND]), 42426 (parotidectomy with lymph node dissection), and 69155 (mastoid resection with lymph node dissection). Second, NSQIP was queried to identify all neck dissection procedures with CPT codes in extirpative procedures with involvement of the oropharyngeal tract (ie, ‘‘contaminated’’ cases). This included primary, other, or concomitant codes, including 41153 (partial glossectomy with floor of mouth resection and LND), 31390 (pharyngolaryngectomy and LND), 31395 (pharyngolaryngectomy and LND with reconstruction), 41135 (glossectomy and LND), 41145 (glossectomy and LND), and 41155 (composite mandible resection and LND). Any patients with CPT codes that caused overlap between ‘‘clean’’ and ‘‘contaminated’’ were considered ‘‘contaminated’’ cases during cohort analysis. Patients with incomplete demographic data (ie, no sex information) were excluded. A total of 9462 patients were thus identified. Patient demographics, medical comorbidities, and procedural characteristics were analyzed as potential risk factors. Obesity was defined as body mass index (BMI) greater than or equal to 30 kg/m2. Procedural characteristics included were operative time and anesthesia duration. We included anesthesia time in regression analyses to control for underlying differences in the ‘‘clean’’ and ‘‘contaminated’’ cohorts (discussed in detail below). Outcome of Interest The primary outcome of interest for the study was 1 or more adverse events in the 30 days following neck dissection. We defined an adverse event as any of the following: surgical complications, medical complications, reoperation, Statistical Analysis Univariate analysis and multivariable logistic regression models were used to determine significant predictors of complications in patients. Individual variables with 10 event occurrences showing association with complications at a significance level of P .20 in the univariate analysis were included in multivariable models. Based on these criteria, the following variables met criteria for inclusion in multivariable logistic regression analysis: tobacco use; alcohol use; chronic steroid/immunosuppression use; preoperative radiotherapy less than 90 days from the index procedure; chemotherapy less than 30 days from the index procedure, previous operation less than 30 days from the index procedure, dyspnea, hypertension requiring medication, chronic obstructive pulmonary disease (COPD), previous percutaneous intervention (PCI), transient ischemic attack (TIA), previous stroke or CVA, hemiplegia, disseminated cancer, open or infected wound, American Society of Anesthesiologists (ASA) levels 3 to 5, obesity, operative time, anesthesia duration, and age. Notably, thyroidectomy with neck dissection was more commonly performed than other neck dissection procedures (5277 of all cases, or 56% of the total). This inherent bias of the NSQIP data set resulted in a relative overrepresentation of ‘‘clean’’ thyroidectomy procedures, although approximately 25% of ‘‘contaminated’’ cases also included thyroidectomies. Consequently, we performed a subgroup multivariable analysis of the effect of contaminated neck status as a predictor of adverse events, with the removal of all thyroidectomy procedures (both ‘‘clean’’ and ‘‘contaminated’’). This left 4183 patients for evaluation. Based on power calculations, all analyses were sufficiently powered to detect significant differences with a probability of at least .05. A Hosmer-Lemeshow (HL) test and C-statistic for calibration were computed to assess the goodness-of-fit model. We chose the HL test and C-statistic to assess goodness of fit, since in a large dataset (such as NSQIP), it would yield the most sensitivity with respect to significant differences between our observed and model-predicted values. Results A total of 9632 patients were extracted from the 2006-2011 NSQIP data sets. In total, 172 patients had incomplete data, Downloaded from oto.sagepub.com at SOCIEDADE BRASILEIRA DE CIRUR on July 2, 2015 Jain et al 73 Table 1. Patient Case Totals vs Current Procedural Terminology (CPT) Code Type and Description. CPT Code and Description No. of Cases 31390 Pharyngolaryngectomy, with radical neck dissection; without reconstruction 31395 Pharyngolaryngectomy, with radical neck dissection; with reconstruction 38700 Suprahyoid lymphadenectomy 38720 Cervical lymphadenectomy (complete) 38724 Cervical lymphadenectomy (modified radical neck dissection) 41135 Glossectomy; partial, with unilateral radical neck dissection 41145 Glossectomy; complete or total, with or without tracheostomy, with unilateral radical neck dissection 41153 Glossectomy; composite procedure with resection floor of mouth, with suprahyoid neck dissection 41155 Glossectomy; composite procedure with resection floor of mouth, mandibular resection, and radical neck dissection (Commando type) 42426 Excision of parotid tumor or parotid gland; total, with unilateral radical neck dissection 60252 Thyroidectomy, total or subtotal for malignancy; with limited neck dissection 60254 Thyroidectomy, total or subtotal for malignancy; with radical neck dissection 69511 Mastoidectomy; radical thus leaving 9462 patients for analysis. Of these 9462 patients who underwent primary or adjunctive neck dissection, 8890 were considered ‘‘clean’’ neck dissections, and 572 were considered ‘‘contaminated’’ neck dissections. A total of 128 (1.44%) ‘‘clean’’ patients and 19 (3.32%) ‘‘contaminated’’ patients had a history of radiation therapy (by NSQIP definition). A breakdown of case totals by CPT procedure code is found in Table 1. With regard to postoperative entries for diagnosis codes, there were 3154 thyroid primary cases, 536 lymph node primary cases, 280 oropharyngeal primary cases, 183 skin primary cases, 133 larynx primary cases, and 90 parathyroid primary cases. Of the cases, 477 had diagnosis codes not directly attributable to a specific head and neck cancer subset, while 4609 did not have any diagnosis code recorded. In total, 990 patients (10.5%) had at least 1 adverse event within 30 days of the primary procedure. The 2 patient cohorts were significantly different with respect to a number of preoperative and operative characteristics on univariate analysis (Table 2), indicating a higher level of attendant comorbid disease and degree of procedural complexity in the ‘‘contaminated’’ cohort. On univariate analysis, nearly every category of complication was significantly increased in the ‘‘contaminated’’ compared with the ‘‘clean’’ cohort. This included any complication (P \ .001), any surgical complication (P \ .001), any medical complication (P \ .001), unplanned reoperation (P \ .001), and mortality (P \ .001) (Table 3). The most common surgical complication was superficial surgical site infection (SSI), with a total of 131 cases. Of these 131 infections, 94 (1.06%) were in clean cases, and 37 (6.47%) were in contaminated cases (P \ .001). The most common medical complication was blood transfusion (P \ .001), given intraoperatively or within 72 hours of surgery, followed by pneumonia (P \ .001) and ventilator dependence greater than 48 hours postoperatively (P \ .001). 117 81 120 425 2675 184 41 36 113 392 4569 708 1 We subsequently performed risk-adjusted multivariable logistic regression to analyze factors associated with surgical or medical complications, while controlling for the extensive baseline differences between cohorts. The incidence of any surgical complication was most strongly associated with ‘‘contaminated’’ cases (odds ratio [OR], 3.42; 95% confidence interval [CI], 1.96-5.96; P \ .001) (Table 4). Other factors included a history of radiation therapy within 90 days of the index procedure (P = .027) and increasing anesthesia duration (P = .006; HosmerLemeshow [HL] test = 0.370). Medical complications were not significantly associated with ‘‘contaminated’’ case type (P = .810). However, they were significantly associated with chronic steroid/immunosuppression use (P = .006), chemotherapy within 30 days prior to the index procedure (P = .004), dyspnea (P = .017), COPD (P = .026), ASA classes 3 to 5 (P \ .001), increasing anesthesia duration (P \ .001), and increasing age (P \ .001; HL test = 0.049) (Table 5). Notably, thyroidectomy with neck dissection was more commonly performed than other neck dissection procedures (5277 of all cases, or 56% of the total). This inherent bias of the NSQIP data set resulted in a relative overrepresentation of ‘‘clean’’ thyroidectomy procedures, although approximately 25% of ‘‘contaminated’’ cases also included thyroidectomies. Consequently, we repeated our multivariable analysis of the effect of contaminated neck status as a predictor of adverse events, with the complete removal of all thyroidectomy procedures (both ‘‘clean’’ and ‘‘contaminated’’). This resulted in a subgroup population of 4183 patients. Analysis of this subgroup demonstrated the same result: contaminated neck dissection is associated with statistically significant increased risk of surgical complications, as well as reoperation (OR, 2.33 and 1.87; P = .008 and 0.006, respectively) (Table 6). Discussion Despite being a mainstay procedure in head and neck surgery, neck dissection has limited data regarding factors Downloaded from oto.sagepub.com at SOCIEDADE BRASILEIRA DE CIRUR on July 2, 2015 74 Otolaryngology–Head and Neck Surgery 153(1) Table 2. Patient Demographics vs Neck Dissection Cohort (Univariate Analysis).a Characteristic Clinical characteristics Smokers Alcohol use Steroid use Preoperative radiotherapy Chemotherapy Previous operation \30 days Comorbidities Diabetes Dyspnea Hypertension COPD Congestive heart failure Bleeding disorders Previous PCI Previous cardiac surgery Stroke (with neurological deficit) TIA Hemiplegia Disseminated cancer ASA Levels 3-5 Obesity Procedure characteristics, mean 6 SD Operative time, min Duration of anesthesia, min Age, y Clean (n = 8890) Contaminated (n = 572) P Value 1327 (14.93) 232 (2.61) 186 (2.09) 128 (1.44) 103 (1.16) 180 (2.02) 236 (41.26) 70 (12.24) 17 (2.97) 19 (3.32) 13 (2.27) 25 (4.37) .000b .000b .159 .000b .019b .000b 912 (10.26) 530 (5.96) 3143 (35.35) 213 (2.40) 16 (0.18) 145 (1.63) 240 (2.70) 218 (2.45) 73 (0.82) 111 (1.25) 24 (0.27) 491 (5.52) 3165 (35.60) 3001 (33.76) 66 (11.54) 100 (17.48) 278 (48.60) 70 (12.24) 2 (0.35) 8 (1.40) 32 (5.59) 18 (3.15) 20 (3.50) 14 (2.45) 5 (0.87) 60 (10.49) 441 (77.10) 120 (20.98) .330 .000b .000b .000b .298 .417 .000b .302 .000b .015b .028b .000b .000b .000b 205.99 6 143.96 267.61 6 155.78 52.28 6 15.92 408.86 6 223.51 486.31 6 240.69 61.45 6 12.7 .000b .000b .000b Abbreviations: ASA, American Society of Anesthesiologists; COPD, chronic obstructive pulmonary disease; PCI, percutaneous intervention; TIA, transient ischemic attack. a Values are presented as number (%) unless otherwise indicated. b Denotes significant value, P \.05. associated with adverse outcomes. Prior single-institution/ single-surgeon studies have cited complication rates after neck dissection between 3% and 28%.1,5,14 Use of the NSQIP database offers the ability to systematically track all types of adverse events (ie, surgical and medical complications, reoperation, readmission, mortality) and their risk factors across multiple institutions, thus permitting more consistent benchmarking for quality improvement, risk stratification, and patient informed consent. In the current study, oropharyngeal contamination was significantly associated with nearly every type of adverse event on univariate analysis. To account for numerous significant differences between the ‘‘clean’’ and ‘‘contaminated’’ cohorts (Table 2), multivariable logistic regression models were used to control for baseline differences. Individual variables with 10 event occurrences showing association with complications at a significance level of P .20 in the univariate analysis were included in multivariable models. Subsequently, on multivariable analysis, ‘‘contaminated’’ status was only associated with surgical complications, with a compelling OR of 3.42 (P \ .001). Notably, the NSQIP database has an inherent bias, in that thyroidectomy with neck dissection was more commonly performed than other neck dissection procedures. We subsequently performed a subgroup analysis, using all patients except those with thyroidectomy codes (n = 4183). After this subgroup analysis, our findings were unchanged (Table 6). Contaminated neck dissection continued to be associated with a statistically significant increased risk of surgical complications, as well as reoperation. Previously identified risk factors for adverse events after neck dissection include tumor stage, operative duration, and major reconstruction.7,15 The NSQIP does not track tumor stage but instead has a variable for ‘‘disseminated cancer’’; this variable was not associated with adverse events of any type. We also found a number of previously unidentified factors associated with adverse events, including chronic steroid use/immunosuppression, preoperative radiotherapy within 90 days of the index procedure, chemotherapy within 30 days of the index procedure, dyspnea, COPD, advanced age, and ASA classes 3 to 5. Each of these factors has Downloaded from oto.sagepub.com at SOCIEDADE BRASILEIRA DE CIRUR on July 2, 2015 Jain et al 75 Table 3. Thirty-Day Adverse Events vs Neck Dissection Cohort (Univariate Analysis). Clean, No. (%) Table 4. Multivariable Regression Analysis for Factors Associated with Surgical Complications after Neck Dissection.a Contaminated, No. (%) P Value Surgical complications All SSIs Superficial SSI 94 (1.06) Deep SSI 39 (0.44) Organ/space SSI 14 (0.16) Wound disruption 50 (0.56) Medical complications Pneumonia 99 (1.11) Unplanned intubation 73 (0.82) PE 17 (0.19) Ventilator .48 h 79 (0.89) Renal insufficiency 6 (0.07) Acute renal failure 4 (0.04) UTI 43 (0.48) Peripheral neurologic deficit 16 (0.18) Cardiac arrest 15 (0.17) Blood transfusion 195 (2.19) DVT 22 (0.25) Systemic sepsis 59 (0.66) Septic shock 15 (0.17) MI 18 (0.20) Stroke 9 (0.10) Coma 5 (0.06) Mortality 21 (0.24) 37 (6.47) 16 (2.80) 3 (0.52) 24 (4.20) .000a .000a .079 .000a 25 (4.37) 19 (3.32) 3 (0.52) 40 (6.99) 1 (0.17) 0 (0.00) 9 (1.57) 3 (0.52) 9 (1.57) 72 (12.59) 5 (0.87) 22 (3.85) 6 (1.05) 4 (0.70) 1 (0.17) 0 (0.00) 10 (1.75) .000a .000a .117 .000a .354 .779 .004a .104 .000a .000a .021a .000a .001a .041a .464 .732 .000a Neck dissection cohort Clean Contaminated Smoker Excess alcohol intake Steroid use Preoperative radiotherapy Chemotherapy Prior operation \30 days Dyspnea Hypertension requiring medication History of COPD Previous PCI Cerebrovascular accident History of TIA Disseminated cancer ASA .3 Obesity (BMI .30) Operative duration Anesthesia duration Age Odds Ratio 95% CI P Value 1 [reference] 3.422 1.152 0.758 0.834 2.326 0.82 0.365 1.286 1.055 1.963-5.964 0.773-1.714 0.391-1.469 0.289-2.404 1.102-4.913 0.305-2.208 0.111-1.197 0.759-2.179 0.728-1.528 .000b .487 .411 .736 .027b .695 .096 .351 .777 0.479 1.242 1.520 0.440 1.303 1.483 0.959 1.000 1.003 1.007 0.208-1.104 0.621-2.483 0.566-4.086 0.099-1.959 0.787-2.158 0.99-2.221 0.661-1.389 0.998-1.003 1.001-1.006 0.994-1.02 .084 .540 .406 .281 .303 .056 .823 .950 .006b .289 Abbreviations: DVT, deep venous thrombosis; PE, pulmonary embolism; SSI, surgical site infection; MI, myocardial infarction; UTI, urinary tract infection. a Denotes significant value, P \.05. Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index; CI, confidence interval; COPD, chronic obstructive pulmonary disease; PCI, percutaneous intervention; TIA, transient ischemic attack. a Hosmer-Lemeshow test statistic of .215. b Denotes significant value, P \.05. previously been identified as a predictor of adverse events in other surgical settings but not in head and neck surgery.16-30 Surgical complications identified in the NSQIP database include SSI and wound disruption. Surgical site infection, as defined in the NSQIP database, stratifies infection occurring within 30 days after the operation into 3 categories: superficial wound infection, deep incisional infection, and organ space infection. Superficial site infections require identification of purulent drainage or organisms isolated from aseptic culture from fluid or tissue from the superficial incision after the incision is opened by the surgeon. Deep infections differ by involvement of fascia or muscle layers with either spontaneous opening or deliberate opening by the surgeon with symptoms including temperature over 38°C and pain. Organ space infection involves any organ or space, other than the incision, that was opened during an operation. These rigorous, standardized definitions likely contribute to the relatively low incidence of neck SSIs found in this study (ie, 2% for clean and 9% for contaminated cases). Although the current study is not able to evaluate this proposition, the role of prophylactic antibiotics in preventing SSI in head and neck procedures has been extensively studied at single institutions.3,8-10,14,15,31-35 The authors assume that standard protocols for antibiotic prophylaxis in head and neck procedures were used in recorded cases. It should be noted, however, that the relatively low rate of surgical infection after neck dissections captured in the NSQIP data set (ie, 2%-9%, compared with 3%-28% in published literature) will likely affect any such future studies on this subject. Previous research has shown an increased risk of medical complications, such as pneumonia, sepsis, respiratory failure, and urinary tract infection (UTI) in head and neck surgical procedures contaminated with oropharyngeal flora.8,9,36-41 In contrast, our study did not find a significant association between oropharyngeal contamination and medical adverse events. Reasons for these discrepancies may include (1) a lack of sufficient statistical power in previous studies, (2) inconsistencies in adverse event identification in the postoperative period, and/or (3) errors in procedural tracking. In light of these discrepancies, further research should be spent examining these differences and whether they are due to data collection or significant changes in patient care that have decreased medical morbidity associated with contaminated neck dissections. Downloaded from oto.sagepub.com at SOCIEDADE BRASILEIRA DE CIRUR on July 2, 2015 76 Otolaryngology–Head and Neck Surgery 153(1) Table 5. Multivariable Regression Analysis for Factors Associated with Medical Complications after Neck Dissection.a Odds Ratio Neck dissection cohort Clean Contaminated Smoker Excess alcohol intake Steroid use Preoperative radiotherapy Chemotherapy Prior operation \30 days Dyspnea Hypertension requiring medication History of COPD Previous PCI Cerebrovascular accident History of TIA Disseminated cancer ASA .3 Obesity (BMI .30) Operative duration Anesthesia duration Age 95% CI P Value 1 [reference] 0.953 1.193 1.187 2.087 1.103 2.303 0.997 1.497 1.061 0.644-1.411 0.912-1.56 0.797-1.767 1.239-3.514 0.608-2.002 1.296-4.093 0.592-1.679 1.073-2.087 0.834-1.349 .810 .198 .398 .006b .748 .004b .992 .017b .631 1.59 1.028 1.316 1.051 0.994 1.705 0.897 1.001 1.004 1.029 1.056-2.394 0.663-1.594 0.667-2.597 0.55-2.01 0.699-1.413 1.305-2.228 0.701-1.148 0.999-1.002 1.002-1.006 1.02-1.038 .026b .902 .428 .880 .972 .000b .388 .526 .000b .000b Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index; CI, confidence interval; COPD, chronic obstructive pulmonary disease; PCI, percutaneous intervention; TIA, transient ischemic attack. a Hosmer-Lemeshow test statistic of .061. b Denotes significant value, P \.05. Staged neck dissection has demonstrated efficacy in a number of clinical scenarios and could decrease the risk of oropharyngeal contamination. These include transoral surgery for oropharyngeal cancer, in which there is an opportunity for performing the neck dissection either before or after surgical excision of the primary tumor, and in patients treated primarily with chemoradiation for advanced head and neck cancer.42-46 In addition, surgeons could make efforts to separate oropharyngeal and neck dissection fields by minimizing mucosal violation whenever possible. While these maneuvers seem reasonable in early stage oral cancer, in advanced cancer, the resection specimen is often contiguous with the neck dissection, and thus separation of the 2 surgical sites is impossible. While soft tissue flaps could be used to decrease anatomic dead spaces, provide anatomic barriers, and improve the vascularity of surgical beds, examination of such techniques is beyond the scope of this article. There are a number of limitations in our study. We did not define the specific duration for the onset of complications from the time of surgery, nor did we identify if complications occurred pre- or postdischarge. Misclassification of procedure CPT codes has been cited as a limitation of the NSQIP database, although interobserver reliability is Table 6. Odds Ratio Analysis for Contaminated Neck Dissection vs Clean Neck Dissection (as Reference), Excluding All Cases Involving Thyroidectomy (Current Procedural Terminology Codes 60210, 60212, 60220, 60225, 60240, 60252, 60254, 60260, 60270, 60271, 60500). Surgical complications Medical complications Total complications Reoperation Readmission Death Odds Ratio 95% CI P Value 2.333 0.871 1.056 1.868 0.907 0.782 1.25-4.355 0.583-1.302 0.727-1.535 1.199-2.911 0.331-2.486 0.17-3.595 .008a .502 .775 .006a .86 .752 Abbreviation: CI, confidence interval. a Denotes significant value, P \.05. .98%.47 In addition, the study evaluates both specialists and nonspecialists, as neck dissection is not necessarily performed by surgeons with oncologic surgical training. As has been described in other studies, the NSQIP does not track procedure-specific or specialty-specific outcomes and complications (eg, chyle leak, pharyngeal fistula, hemorrhage). The authors defined ‘‘clean’’ vs ‘‘contaminated’’ cases on the basis of CPT codes. While patients undergoing ‘‘contaminated’’ procedures had greater attendant presurgical comorbidity than did patients undergoing ‘‘clean’’ procedures, multivariate analysis was used to control for those variables with P \ .2 and n . 10 (Tables 3 and 4).19,20 Our method does not allow the head-to-head comparison of specific procedures (as identified by CPT codes), since, for example, all composite mandible resections are considered ‘‘dirty,’’ while all parotidectomies are considered ‘‘clean.’’ As a caveat, some patients with simple oral excisions (eg, glossectomies) may not have been contaminated if there was no direct communication with the neck dissection and therefore may have been misclassified. Conversely, some ‘‘clean’’ cutaneous or salivary lesions (eg, parotidectomies) may have been contaminated if there was violation of the oral mucosa. While there are a number of options to clarify these inconsistencies (eg, using concurrent free flap codes to identify cases where oral mucosa was violated), such analyses were not performed. Finally, we attempted to focus on oropharyngeal (as opposed to laryngeal and respiratory) contamination by removing those patients with laryngectomies as their sole extirpative surgery. However, it is still possible to have respiratory contamination from cases undergoing pharyngolaryngectomies and/or concomitant tracheostomy, and there is no feasible way to discriminate the source of contamination in the NSQIP. Regardless of these limitations, the current study helps to define the relationship between oropharyngeal contamination and adverse events after neck dissection. It should be used for individual patient risk stratification by providers, health care monitoring agencies, and payors to subgroup those patients undergoing ‘‘contaminated’’ neck dissection Downloaded from oto.sagepub.com at SOCIEDADE BRASILEIRA DE CIRUR on July 2, 2015 Jain et al 77 procedures into a category with an expected increased risk of postoperative adverse events (specifically, 2-3 times above baseline risk). Similarly, patients can be informed that their particular surgery may confer significantly elevated risk of surgical adverse events and reoperation compared with ‘‘clean’’ neck dissections. In an era of consumerdriven health care, whether these factors will drive patients to seek less invasive techniques (eg, trans-oral robotic surgery [TORS] chemoradiation), remains to be seen. Future study should focus on evaluating (1) the length of antibiotic administration for oropharyngeal exposure during neck dissection; (2) the relationship between preexisting infection, dentition status, dental extraction, and infection; and (3) the feasibility of separating neck dissection from oropharyngeal extirpation (eg, subgroup analysis of patients undergoing composite mandible resection with immediate vs delayed neck dissection). As the NSQIP data set continues to evolve, these analyses should be feasible. 3. 4. 5. 6. 7. Authors’ Note The NSQIP and the hospitals participating in the NSQIP are the source of the data used herein; they have not been verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors of this study. De-identified patient information is freely available to all institutional members who comply with the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) Data Use Agreement. The Data Use Agreement implements the protections afforded by the Health Insurance Portability and Accountability Act of 1996. 8. 9. 10. 11. Author Contributions Umang Jain, study design, data analysis, drafting, revision manuscript, final approval of manuscript, accountable for all aspects of the work; Jessica Somerville, study design, data analysis, drafting, revision manuscript, final approval of manuscript, accountable for all aspects of the work; Sujata Saha, study design, data analysis, drafting, revision manuscript, final approval of manuscript, accountable for all aspects of the work; Nicholas James Hackett, study design, data analysis, drafting, revision manuscript, final approval of manuscript, accountable for all aspects of the work; Jon P. Ver Halen, study design, data analysis, drafting, revision manuscript, final approval of manuscript, accountable for all aspects of the work; Anuja K. Antony, study design, data analysis, drafting, revision manuscript, final approval of manuscript, accountable for all aspects of the work; Sandeep Samant, study design, data analysis, drafting, revision manuscript, final approval of manuscript, accountable for all aspects of the work. 12. 13. 14. 15. 16. Disclosures Competing interests: None. Sponsorships: None. 17. Funding source: None. References 1. Tracy JC, Spiro JD. Short hospital stay following neck dissection. Arch Otolaryngol Head Neck Surg. 2010;136:773-776. 2. Shellenberger TD, Madero-Visbal R, Weber RS. Quality indicators in head and neck operations: a comparison with 18. published benchmarks. Arch Otolaryngol Head Neck Surg. 2011;137:1086-1093. Penel N, Fournier C, Lefebvre D, Lefebvre JL. 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