Cost of benign versus oncologic colon resection among fee-for-service Medicare enrollees.

BACKGROUND AND OBJECTIVES: Reimbursement for colonic pathology by the Centers for Medicare and Medicaid Services (CMS) are grouped in the Medicare Severity-Diagnosis Related Groups (MS-DRG). With limited available data, we sought to compare the relative impact of malignant vs benign colonic pathology on reimbursement under the MS-DRG system. METHODS: We used 5% national Medicare data from 2011 to 2014. Patients were classified as having benign disease or malignancy. Descriptive statistics and multivariate regression analysis were used to evaluate the surgical approach and health resource utilization. RESULTS: Of 10 928 patients, most were Non-Hispanic White women. The majority underwent open colectomy in both cohorts (P < .001). Colectomy for benign disease was associated with higher total charges (P < .001) and a longer length of stay (P = .0002). Despite higher charges, payments were not significantly different between the cohorts (P = .434). Both inpatient mortality and discharge to a rehab facility were higher in the oncologic group (P < .001). CONCLUSION: Payment methodology for colectomy under the CMS MS-DRG system does not appear to accurately reflect the episode cost of care. The data suggest that inpatient costs are not fully compensated. A transition to value-based payments with expanded episode duration will require a better understanding of unique costs before adoption.

Adapting the Elixhauser comorbidity index for cancer patients.

BACKGROUND: This study was designed to adapt the Elixhauser comorbidity index for 4 cancer-specific populations (breast, prostate, lung, and colorectal) and compare 3 versions of the Elixhauser comorbidity score (individual comorbidities, summary comorbidity score, and cancer-specific summary comorbidity score) with 3 versions of the Charlson comorbidity score for predicting 2-year survival with 4 types of cancer. METHODS: This cohort study used Texas Cancer Registry-linked Medicare data from 2005 to 2011 for older patients diagnosed with breast (n = 19,082), prostate (n = 23,044), lung (n = 26,047), or colorectal cancer (n = 16,693). For each cancer cohort, the data were split into training and validation cohorts. In the training cohort, competing risk regression was used to model the association of Elixhauser comorbidities with 2-year noncancer mortality, and cancer-specific weights were derived for each comorbidity. In the validation cohort, competing risk regression was used to compare 3 versions of the Elixhauser comorbidity score with 3 versions of the Charlson comorbidity score. Model performance was evaluated with c statistics. RESULTS: The 2-year noncancer mortality rates were 14.5% (lung cancer), 11.5% (colorectal cancer), 5.7% (breast cancer), and 4.1% (prostate cancer). Cancer-specific Elixhauser comorbidity scores (c = 0.773 for breast cancer, c = 0.772 for prostate cancer, c = 0.579 for lung cancer, and c = 0.680 for colorectal cancer) performed slightly better than cancer-specific Charlson comorbidity scores (ie, the National Cancer Institute combined index; c = 0.762 for breast cancer, c = 0.767 for prostate cancer, c = 0.578 for lung cancer, and c = 0.674 for colorectal cancer). Individual Elixhauser comorbidities performed best (c = 0.779 for breast cancer, c = 0.783 for prostate cancer, c = 0.587 for lung cancer, and c = 0.687 for colorectal cancer). CONCLUSIONS: The cancer-specific Elixhauser comorbidity score performed as well as or slightly better than the cancer-specific Charlson comorbidity score in predicting 2-year survival. If the sample size permits, using individual Elixhauser comorbidities may be the best way to control for confounding in cancer outcomes research. Cancer 2018;124:2018-25. © 2018 American Cancer Society.

Predicting opportunities to increase utilization of laparoscopy for rectal cancer.

BACKGROUND: Despite proven safety and efficacy, rates of laparoscopy for rectal cancer in the US are low. With reports of inferiority with laparoscopy compared to open surgery, and movements to develop accredited centers, investigating utilization and predictors of laparoscopy are warranted. Our goal was to evaluate current utilization and identify factors impacting use of laparoscopic surgery for rectal cancer. METHODS: The Premier™ Hospital Database was reviewed for elective inpatient rectal cancer resections (1/1/2010-6/30/2015). Patients were identified by ICD-9-CM diagnosis codes, and then stratified into open or laparoscopic approaches by ICD-9-CM procedure codes or billing charge. Logistic multivariable regression identified variables predictive of laparoscopy. The Cochran-Armitage test assessed trend analysis. The main outcome measures were trends in utilization and factors independently associated with use of laparoscopy. RESULTS: 3336 patients were included-43.8% laparoscopic (n = 1464) and 56.2% open (n = 1872). Use of laparoscopy increased from 37.6 to 55.3% during the study period (p < 0.0001). General surgeons performed the majority of all resections, but colorectal surgeons were more likely to approach rectal cancer laparoscopically (41.31 vs. 36.65%, OR 1.082, 95% CI [0.92, 1.27], p < 0.3363). Higher volume surgeons were more likely to use laparoscopy than low-volume surgeons (OR 3.72, 95% CI [2.64, 5.25], p < 0.0001). Younger patients (OR 1.49, 95% CI [1.03, 2.17], p = 0.036) with minor (OR 2.13, 95% CI [1.45, 3.12], p < 0.0001) or moderate illness severity (OR 1.582, 95% CI [1.08, 2.31], p < 0.0174) were more likely to receive a laparoscopic resection. Teaching hospitals (OR 0.842, 95% CI [0.710, 0.997], p = 0.0463) and hospitals in the Midwest (OR 0.69, 95% CI [0.54, 0.89], p = 0.0044) were less likely to use laparoscopy. Insurance status and hospital size did not impact use. CONCLUSIONS: Laparoscopy for rectal cancer steadily increased over the years examined. Patient, provider, and regional variables exist, with hospital status, geographic location, and colorectal specialization impacting the likelihood. However, surgeon volume had the greatest influence. These results emphasize training and surgeon-specific outcomes to increase utilization and quality in appropriate cases.

American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway.

Perioperative malnutrition has proven to be challenging to define, diagnose, and treat. Despite these challenges, it is well known that suboptimal nutritional status is a strong independent predictor of poor postoperative outcomes. Although perioperative caregivers consistently express recognition of the importance of nutrition screening and optimization in the perioperative period, implementation of evidence-based perioperative nutrition guidelines and pathways in the United States has been quite limited and needs to be addressed in surgery-focused recommendations. The second Perioperative Quality Initiative brought together a group of international experts with the objective of providing consensus recommendations on this important topic with the goal of (1) developing guidelines for screening of nutritional status to identify patients at risk for adverse outcomes due to malnutrition; (2) address optimal methods of providing nutritional support and optimizing nutrition status preoperatively; and (3) identifying when and how to optimize nutrition delivery in the postoperative period. Discussion led to strong recommendations for implementation of routine preoperative nutrition screening to identify patients in need of preoperative nutrition optimization. Postoperatively, nutrition delivery should be restarted immediately after surgery. The key role of oral nutrition supplements, enteral nutrition, and parenteral nutrition (implemented in that order) in most perioperative patients was advocated for with protein delivery being more important than total calorie delivery. Finally, the role of often-inadequate nutrition intake in the posthospital setting was discussed, and the role of postdischarge oral nutrition supplements was emphasized.

American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Patient-Reported Outcomes in an Enhanced Recovery Pathway.

Patient-reported outcomes (PROs) are measures of health status that come directly from the patient. PROs are an underutilized tool in the perioperative setting. Enhanced recovery pathways (ERPs) have primarily focused on traditional measures of health care quality such as complications and hospital length of stay. These measures do not capture postdischarge outcomes that are meaningful to patients such as function or freedom from disability. PROs can be used to facilitate shared decisions between patients and providers before surgery and establish benchmark recovery goals after surgery. PROs can also be utilized in quality improvement initiatives and clinical research studies. An expert panel, the Perioperative Quality Initiative (POQI) workgroup, conducted an extensive literature review to determine best practices for the incorporation of PROs in an ERP. This international group of experienced clinicians from North America and Europe met at Stony Brook, NY, on December 2-3, 2016, to review the evidence supporting the use of PROs in the context of surgical recovery. A modified Delphi method was used to capture the collective expertise of a diverse group to answer clinical questions. During 3 plenary sessions, the POQI PRO subgroup presented clinical questions based on a literature review, presented evidenced-based answers to those questions, and developed recommendations which represented a consensus opinion regarding the use of PROs in the context of an ERP. The POQI workgroup identified key criteria to evaluate patient-reported outcome measures (PROMs) for their incorporation in an ERP. The POQI workgroup agreed on the following recommendations: (1) PROMs in the perioperative setting should be collected in the framework of physical, mental, and social domains. (2) These data should be collected preoperatively at baseline, during the immediate postoperative time period, and after hospital discharge. (3) In the immediate postoperative setting, we recommend using the Quality of Recovery-15 score. After discharge at 30 and 90 days, we recommend the use of the World Health Organization Disability Assessment Scale 2.0, or a tailored use of the Patient-Reported Outcomes Measurement Information System. (4) Future study that consistently applies PROMs in an ERP will define the role these measures will have evaluating quality and guiding clinical care. Consensus guidelines regarding the incorporation of PRO measures in an ERP were created by the POQI workgroup. The inclusion of PROMs with traditional measures of health care quality after surgery provides an opportunity to improve clinical care.

American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Gastrointestinal Dysfunction Within an Enhanced Recovery Pathway for Elective Colorectal Surgery.

The primary driver of length of stay after bowel surgery, particularly colorectal surgery, is the time to return of gastrointestinal (GI) function. Traditionally, delayed GI recovery was thought to be a routine and unavoidable consequence of surgery, but this has been shown to be false in the modern era owing to the proliferation of enhanced recovery protocols. However, impaired GI function is still common after colorectal surgery, and the current literature is ambiguous with regard to the definition of postoperative GI dysfunction (POGD), or what is typically referred to as ileus. This persistent ambiguity has impeded the ability to ascertain the true incidence of the condition and study it properly within a research setting. Furthermore, a rational and standardized approach to prevention and treatment of POGD is needed. The second Perioperative Quality Initiative brought together a group of international experts to review the published literature and provide consensus recommendations on this important topic with the goal to (1) develop a rational definition for POGD that can serve as a framework for clinical and research efforts; (2) critically review the evidence behind current prevention strategies and provide consensus recommendations; and (3) develop rational treatment strategies that take into account the wide spectrum of impaired GI function in the postoperative period.

Predicting opportunities to increase utilization of laparoscopy for colon cancer.

BACKGROUND: Despite proven safety and efficacy, rates of minimally invasive approaches for colon cancer remain low in the USA. Given the known benefits, investigating the root causes of underutilization and methods to increase laparoscopy is warranted. Our goal was to develop a predictive model of factors impacting use of laparoscopic surgery for colon cancer. METHODS: The Premier Hospital Database was reviewed for elective colorectal resections for colon cancer (2009-2014). Patients were identified by ICD-9-CM diagnosis code and then stratified into open or laparoscopic approaches by ICD-9-CM procedure codes. An adjusted multivariate logistic regression model identified variables predictive of use of laparoscopy for colon cancer. RESULTS: A total of 24,245 patients were included-12,523 (52 %) laparoscopic and 11,722 (48 %) open. General surgeons performed the majority of all procedures (77.99 % open, 71.60 % laparoscopic). Overall use of laparoscopy increased from 48.94 to 52.03 % over the study period (p < 0.0001). Patients with private insurance were more likely to have laparoscopy compared with Medicare patients (adjusted odds ratio (OR) 1.089, 95 % CI [1.004, 1.181], p = 0.0388). Higher volume of surgeons (OR 3.518, 95 % CI [2.796, 4.428], p < 0.0001) and larger hospitals by bed size were more likely to approach colon cancer laparoscopically. Colorectal surgeons were 32 % more likely to approach a case laparoscopically than general surgeons (OR 1.315, 95 % CI [1.222, 1.415], p < 0.0001). Teaching hospitals, hospitals in the Midwest, and hospitals with less than 500 beds were less likely to use laparoscopy. CONCLUSIONS: There are patient, provider, and hospital characteristics that can be identified preoperatively to predict who will undergo surgery for colon cancer using laparoscopy. However, additional patients may be eligible for laparoscopy based on patient-level characteristics. These results have implications for regionalization and increasing teaching of MIS. Recognizing and addressing these variables with training and recruiting could increase use of minimally invasive approaches, with the associated clinical and financial benefits.

Uptake of enhanced recovery practices by SAGES members: a survey.

BACKGROUND: The SAGES Surgical Multimodal Accelerated Recovery Trajectory (SMART) Enhanced Recovery Task Force aims to increase awareness and provide tools for members to successfully implement enhanced recovery pathways (ERPs) to improve clinical outcomes and patient satisfaction. An initial step was to survey SAGES member on their knowledge, use, and impediments to enhanced recovery. METHODS: An online survey designed by SMART committee members to define SAGES member's awareness and use of enhanced recovery principles and practice was emailed to all SAGES members. Reminders were sent 2 and 3 weeks later, encouraging completion of the survey. The web-based survey included 48 questions and took an estimated 20 min to complete. RESULTS: A total of 229 members completed the survey. Respondents were primarily general/MIS surgeons (82.6%) working in an urban location (85.5%), with a bell-shaped age distribution (median 35-44). Almost half regularly used some elements of ERPs (48.7%), but 30% were unfamiliar with the concept. Wide variety in the specific ERP elements used and discharge criteria were reported. The majority had to create and implement their own plan (70.4%). Roadblocks to implementation were inconsistencies with partners/covering physicians (56.3%), nursing education (46.6%), and resources (34.7%). When implemented, members saw improvements in length of stay (88%), patient satisfaction (54.7%), postoperative pain (53.3%), time to return of bowel function (52.7%), and readmissions (16.7%). A need for education and standardization was especially seen in preoperative care, with 74.4% fasting patients from midnight the night before surgery. Wide variations were also reported in pain management practices. An overwhelming majority (89%) reported that having a protocol endorsed by a national organization, such as SAGES, would help with implementation. CONCLUSIONS: From this survey of SAGES members, there is a need for education, tools, and standardized protocols to increase awareness, support implementation, and encourage wider utilization of ERP. The overwhelming majority stated having a protocol endorsed by a national organization, such as SAGES, would facilitate implementation.

A new perspective on the value of minimally invasive colorectal surgery-payer, provider, and patient benefits.

BACKGROUND: The clinical benefits of minimally invasive surgery (MIS) are proven, but overall financial benefits are not fully explored. Our goal was to evaluate the financial benefits of MIS from the payer's perspective to demonstrate the value of minimally invasive colorectal surgery. METHODS: A Truven MarketScan® claim-based analysis identified all 2013 elective, inpatient colectomies. Cases were stratified into open or MIS approaches based on ICD-9 procedure codes; then costs were assessed using a similar distribution across diagnosis related groups (DRGs). Care episodes were compared for average allowed costs, complication, and readmission rates after adjusting costs for demographics, comorbidities, and geographic region. RESULTS: A total of 4615 colectomies were included-2054 (44.5 %) open and 2561 (55.5 %) MIS. Total allowed episode costs were significantly lower MIS than open ($37,540 vs. $45,284, p < 0.001). During the inpatient stay, open cases had significantly greater ICU utilization (3.9 % open vs. 2.0 % MIS, p < 0.001), higher overall complications (52.8 % open vs. 32.3 % MIS, p < 0.001), higher colorectal-specific complications (32.5 % open vs. 17.9 % MIS, p < 0.001), longer LOS (6.39 open vs. 4.44 days MIS, p < 0.001), and higher index admission costs ($39,585 open vs. $33,183 MIS, p < 0.001). Post-discharge, open cases had significantly higher readmission rates/100 cases (11.54 vs. 8.28; p = 0.0013), higher average readmission costs ($3055 vs. $2,514; p = 0.1858), and greater 30-day healthcare costs than MIS ($5699 vs. $4357; p = 0.0033). The net episode cost of care was $7744/patient greater for an open colectomy, even with similar DRG distribution. CONCLUSIONS: In a commercially insured population, the risk-adjusted allowed costs for MIS colectomy episodes were significantly lower than open. The overall cost difference between MIS and open was almost $8000 per patient. This highlights an opportunity for health plans and employers to realize financial benefits by shifting from open to MIS for colectomy. With increasing bundled payment arrangements and accountable care sharing programs, the cost impact of shifting from open to MIS introduces an opportunity for cost savings.

Adoption of Laparoscopic Colorectal Surgery: It Was Quite a Journey.

The adoption of laparoscopic colorectal surgery has been a slow but steady progress. The first adopters rapidly expanded the application of the technology to all colorectal pathology. Issues related to extraction and port site recurrence of cancer delayed widespread adoption until incontrovertible data from well-powered prospective randomized studies confirmed equipoise with open surgery. Since that time, the data has consistently demonstrated patient-care benefits related to reductions in both short- and long-term complications historically associated with open colectomy. The potential for further improvement related to single-port access, robotic assistance, and natural orifice access for both the surgery and/or extraction will await the test of time. However, it is clear now that laparoscopic colorectal surgery is the new standard of care and a key enabler of enhanced recovery programs.

The HARM score: a novel, easy measure to evaluate quality and outcomes in colorectal surgery.

OBJECTIVE: To develop a measurement tool based on HospitAl stay, Readmission, and Mortality rates (HARM) score, which is easily calculated from routine administrative data. Secondary goals were to validate the HARM score on a national inpatient sample. BACKGROUND: Concerns about patient safety, quality, and health care costs have increased demand for outcome measurement. Performance metrics such as Surgical Care Improvement Project and National Surgical Quality Improvement Program have been described, but they require significant personnel and expenses to maintain. METHODS: A national inpatient database was reviewed for all colectomy discharges from 2010 to 2011. Cases were stratified into emergent and elective. For each discharge, a 1 to 10 score was calculated on the basis of length of stay, vital status, and 30-day readmissions. The HARM score was correlated to the complication rate to test validity, and bootstrapping was used to test reliability. RESULTS: A total of 81,622 colectomy discharges were evaluated: 44% emergent and 56% elective. The mean HARM score was 3.04 (SD = 0.57) for emergent and 2.64 (SD = 0.65) for elective cases. For hospitals with a HARM score of less than 2, 2 to 3, 3 to 4, and 4+, the mean complication rates were 30.3%, 41.9%, 49.3%, and 56.6% (emergent) and 15.2%, 18.2%, 24.0%, and 35.6% (elective), respectively. Pearson correlation coefficients for the mean score and the complication rate were 0.45 (P < 0.01) for elective and emergent cases. Bootstrapping correlation demonstrated reliability for emergent and elective cases. CONCLUSIONS: The HARM score is easy, reliable, and valid for assessing quality in colorectal surgery. It may provide a low-cost solution for comparative quality assessment in surgery focused on true outlier performance rather than process or clinical outcome metrics alone.

Virtual reality simulator training for laparoscopic colectomy: what metrics have construct validity?

BACKGROUND: Virtual reality simulation for laparoscopic colectomy has been used for training of surgical residents and has been considered as a model for technical skills assessment of board-eligible colorectal surgeons. However, construct validity (the ability to distinguish between skill levels) must be confirmed before widespread implementation. OBJECTIVE: This study was designed to specifically determine which metrics for laparoscopic sigmoid colectomy have evidence of construct validity. DESIGN: General surgeons that had performed fewer than 30 laparoscopic colon resections and laparoscopic colorectal experts (>200 laparoscopic colon resections) performed laparoscopic sigmoid colectomy on the LAP Mentor model. All participants received a 15-minute instructional warm-up and had never used the simulator before the study. Performance was then compared between each group for 21 metrics (procedural, 14; intraoperative errors, 7) to determine specifically which measurements demonstrate construct validity. Performance was compared with the Mann-Whitney U-test (p < 0.05 was significant). RESULTS: Fifty-three surgeons; 29 general surgeons, and 24 colorectal surgeons enrolled in the study. The virtual reality simulators for laparoscopic sigmoid colectomy demonstrated construct validity for 8 of 14 procedural metrics by distinguishing levels of surgical experience (p < 0.05). The most discriminatory procedural metrics (p < 0.01) favoring experts were reduced instrument path length, accuracy of the peritoneal/medial mobilization, and dissection of the inferior mesenteric artery. Intraoperative errors were not discriminatory for most metrics and favored general surgeons for colonic wall injury (general surgeons, 0.7; colorectal surgeons, 3.5; p = 0.045). LIMITATIONS: Individual variability within the general surgeon and colorectal surgeon groups was not accounted for. CONCLUSIONS: The virtual reality simulators for laparoscopic sigmoid colectomy demonstrated construct validity for 8 procedure-specific metrics. However, using virtual reality simulator metrics to detect intraoperative errors did not discriminate between groups. If the virtual reality simulator continues to be used for the technical assessment of trainees and board-eligible surgeons, the evaluation of performance should be limited to procedural metrics.

Comparative effectiveness of laparoscopic versus robot-assisted colorectal resection.

BACKGROUND: During the past 20 years, laparoscopy has revolutionized colorectal surgery. With proven benefits in patient outcomes and healthcare utilization, laparoscopic colorectal surgery has steadily increased in use. Robotic surgery, a new addition to colorectal surgery, has been suggested to facilitate and overcome limitations of laparoscopic surgery. Our objective was to compare the outcomes of robot-assisted laparoscopic resection (RALR) to laparoscopic resections (LAP) in colorectal surgery. METHODS: A national inpatient database was evaluated for colorectal resections performed over a 30-month period. Cases were divided into traditional LAP and RALR resection groups. Cost of robot acquisition and servicing were not measured. Main outcome measures were hospital length of stay (LOS), operative time, complications, and costs between groups. RESULTS: A total of 17,265 LAP and 744 RARL procedures were identified. The RALR cases had significantly higher total cost ($5,272 increase, p < 0.001) and direct cost ($4,432 increase, p < 0.001), significantly longer operating time (39 min, p < 0.001), and were more likely to develop postoperative bleeding (odds ratio 1.6; p = 0.014) than traditional laparoscopic patients. LOS, complications, and discharge disposition were comparable. Similar findings were noted for both laparoscopic colonic and rectal surgery. CONCLUSIONS: RALR had significantly higher costs and operative time than traditional LAP without a measurable benefit.

Reducing the burden of postoperative ileus: evaluating and implementing an evidence-based strategy.

BACKGROUND: Postoperative ileus remains a significant clinical and economic burden to the health care system. Over the last decade, several advances in both medical and surgical therapies have been made to reduce the incidence and severity of postoperative ileus. Despite these advances, though, the incidence of ileus remains high. This narrative review focuses on interventions aimed to prevent and treat postoperative ileus while presenting a step-by-step process for implementation of an evidenced-based strategy. METHODS: A literature search was performed using Medline/PubMed, and articles related to postoperative ileus were identified. The bibliographies of all retrieved articles were reviewed to obtain additional articles of relevance. RESULTS: There are many factors that can influence gastrointestinal recovery that can be categorized as management-, drug-, or surgery-related. While several strategies exist to improve gastrointestinal recovery, few have been shown to reduce length of hospital stay. These strategies are described here, along with a structured approach organized by preoperative, intraoperative, and postoperative considerations. CONCLUSIONS: Postoperative ileus is associated with a significant clinical and economic burden to the health care system. Strategies such as the development of a multidisciplinary team and the creation of a multimodal protocol are encouraged with continuous quality assurance to assess outcomes at the local level.

Effect of local prolonged-release incisional doxycycline on surgical site infection prophylaxis in abdominal colorectal surgery: The SHIELD 1 randomized clinical trial.

INTRODUCTION: Despite advanced infection control practices including preoperative antibiotic prophylaxis, surgical site infection (SSI) remains a challenge. This study aimed to test whether local administration of a novel prolonged-release Doxycycline-Polymer-Lipid Encapsulation matriX (D-PLEX) before wound closure, concomitantly with standard of care (SOC), reduces the incidence of incisional SSI after elective abdominal colorectal surgery. MATERIALS AND METHODS: This was a phase 3 randomized, controlled, double-blind, multinational study (SHIELD 1) between June 2020 to June 2022. Patients with at least one abdominal incision length >10 cm were randomized 1:1 to the investigational arm (D-PLEX+SOC) or control (SOC) arm . The primary outcome was a composite of incisional SSI, incisional reintervention, and all-cause mortality. RESULTS: A total of 974 patients were analyzed, of whom 579 (59.4%) were male. The mean age (±SD) was 64.2±13.0 years. The primary outcome occurred in 9.3% of D-PLEX patients versus 12.1% (SOC) (risk difference estimate [RDE], -2.8%; 95% CI [-6.7%, 1.0%], P=0.1520). In a pre-specified analysis by incision length, a reduction in the primary outcome was observed in the >20 cm subpopulation: 8% (D-PLEX) versus 17.5% (SOC) (RDE, -9.4%; 95% CI [-15.5%, -3.2%], P=0.0032). In the >10 to ≤20 cm subgroup, no reduction was observed: 9.9% versus 7.9% (RDE, 2.0%; 95% CI [-2.8%, 6.7%], P=0.4133). Exploratory post-hoc analyses of patients with increased SSI risk (≥1 patient-specific comorbidity) indicated a reduction in the incidence of the primary outcome: 9.0% (D-PLEX) versus 13.7% (SOC) (RDE, -4.8%; 95% CI [-9.5%, -0.1%], P=0.0472). The D-PLEX safety profile was good (no difference in treatment-emergent adverse events between the groups). CONCLUSIONS: The SHIELD-1 study did not meet its primary outcome of reduced incisional SSI, incisional reinterventions, or all-cause mortality. Pre-specified and post-hoc analyses suggested that D-PLEX may reduce the incidence of the primary outcome event in patients with increased SSI risk, including lengthy incisions.

Reduction in surgical site infections by localized administration with D-PLEX100 in patients with multiple risk factors undergoing colorectal surgery.

BACKGROUND: D-PLEX100 is a novel drug-eluting lipid polymer matrix that supplies a high, local concentration of doxycycline for approximately 30 days. The objective of this post-hoc analysis was to assess the efficacy of D-PLEX100 in preventing superficial and deep SSIs in patients with ≥2 risk factors. PATIENTS AND METHODS: A post-hoc analysis of a previously reported prospective randomized trial assessing D-PLEX100 plus Standard of Care (SOC) versus SOC alone in colorectal surgery was performed to assess SSI rate in patients with ≥2 risk factors. RESULTS: The overall incidence of SSI was significantly lower for the D-PLEX100 arm (9.9%) versus SOC (21%), p = 0.033. Patients with ≥2 risk factors, SSI incidence was 37.5% for SOC and 15.8% in D-PLEX100 treated patients. CONCLUSIONS: D-PLEX100 reduces the incidence of SSIs beyond benefits associated with SOC treatment alone and including patients with ≥2 risk factors. D-PLEX100 may be a promising addition to established SSI prophylaxis bundles.

Identification of consensus-based quality end points for colorectal surgery.

BACKGROUND: Process and outcome measures for quality assessment of colorectal surgical care are poorly defined. OBJECTIVE: The aim of this study was to develop candidate end points for use in surgeon-specific registries designed for case reporting and quality improvement program development. DESIGN: The study design was based on modified Delphi-based development of consensus quality end points. SETTING: This study was undertaken by the American Society of Colon and Rectal Surgeons Executive Council, Quality Committee, and by the ColoRectal Education System Template Committee, American Board of Colon and Rectal Surgery. PATIENTS: No patients were included in this study. INTERVENTIONS: Six areas of colorectal surgery were defined by members of the American Society of Colon and Rectal Surgeons' Executive Council and the American Board of Colon and Rectal Surgery to cover areas of importance for colorectal surgeons. These included colectomy, rectal cancer, hemorrhoidectomy, anal fistula and abscess, colonoscopy, and rectal prolapse. Relevant American Society of Colon and Rectal Surgeons' committee members through a series of 4 panel discussions identified important demographic, process, and outcome measures in each of these 6 areas that might be suitable for the American College of Surgeons case log. Panel size was sequentially expanded from 8 members to 28 members to include all active committee members. Panelists contributed additional process and outcome measures for inclusion during each discussion. Modified Delphi methodology was used to generate consensus, and, after each panel discussion, members rated the relative importance of each end point from 1 (least important) to 4 (most important). MAIN OUTCOME MEASURES: The mean rating for each process and outcome measure after each round was recorded with the use of standardized definitions for relevant variables. RESULTS: Eighty-nine process and outcome measures were compiled and rated. Mean scores following the final round ranged from a low of 1.3 (anal fistula/abscess, preoperative imaging) to a high of 4.0 (colectomy-anastomotic leak). LIMITATIONS: The limitations of this study involved the use of consensus, small study size, and the fact that no end points were excluded. CONCLUSIONS: With the use of modified Delphi methodology, a consensus-derived ranked list of 89 process and outcome measures was developed in 6 key areas of colorectal surgery. These data provide a framework for development of guideline standards for case-reporting program development initiatives for colon and rectal surgery.

Plasma soluble vascular adhesion molecule-1 levels are persistently elevated during the first month after colorectal cancer resection.

INTRODUCTION: Plasma from the second and third weeks after minimally invasive colorectal resection (MICR) has high levels of the proangiogenic proteins VEGF and angiopoietin 2 and also stimulates, in vitro, endothelial cell (EC) proliferation and migration, which are critical to wound and tumor angiogenesis. Soluble vascular cell adhesion molecule-1 (sVCAM-1) stimulates EC chemotaxis and angiogenesis. The impact of MICR on blood levels of sVCAM-1 is unknown. This study's purpose was to determine plasma sVCAM-1 levels after MICR in colorectal cancer (CRC) patients. METHODS: Blood samples from 90 patients (26% rectal, 74% colon) were obtained preoperatively, on postoperative days (POD) 1 and 3, and at other points during the next 2 months. The late samples were bundled into 7-day time blocks. sVCAM-1 levels were determined in duplicate via ELISA and reported as ng/ml. Student's t test was used for data analysis (significance, P < 0.008 after Bonferroni correction). RESULTS: The mean incision length was 7.3 ± 3.1 cm, and the conversion rate was 3%. Compared with preoperative (PreOp) levels (811.3 ± 233.2), the mean plasma sVCAM-1 level was significantly higher on POD 1 (905.7 ± 292.4, P < 0.001) and POD 3 (977.7 ± 271.8, P < 0.001). Levels remained significantly elevated for the POD 7-13, POD 14-20, POD 21-27, and POD 28-67 time blocks. CONCLUSIONS: MICR for CRC is associated with a persistent increase in plasma sVCAM-1 levels during the first month. This sustained increase may promote angiogenesis and stimulate the growth of residual tumor cells early after surgery.