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Risk Factors and Consequences of Anastomotic Leaks after Colectomy
QUALITY, SAFETY AND OUTCOMES III patient receipt of recommended treatment and subsequent impact on sphincter preservation.
Randomized Prospective Study on Preoperative vs Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery: An Interim Analysis Karen Zaghiyan, MD, Harry C Sax, MD, Seth Felder, MD, Alexandra Gangi, MD, David Cossman, MD, Phillip R Fleshner, MD, FACS Cedars Sinai Medical Center, Los Angeles, CA INTRODUCTION: Current guidelines recommend chemical venous thromboprophylaxis (CVTP) to start either before colorectal surgery or within 24 hours after colorectal surgery. However, there are no studies comparing the incidence of venous thromboembolism (VTE) and bleeding complications between preoperative vs postoperative CVTP. METHODS: A randomized prospective study was performed on patients undergoing major colorectal surgery treated with heparin 5000 units subcutaneous every 8 hours either started before surgery (preoperative CVTP) or with 24 hours after surgery (postoperative CVTP). Duplex sonography was performed preoperatively, immediately postoperatively and on postoperative day 2 (POD2). Bleeding complications were also evaluated. RESULTS: 154 study eligible patients underwent preoperative screening duplex sonography. 4 patients (3%) had a preoperative acute VTE and were excluded. 2 patients were excluded after randomization because they did not undergo the planned operation. Of the 148 patients included in the analysis, 73 received preoperative CVTP and 75 received postoperative CVTP. There was no significant difference in demographic and surgical variables between treatment groups. Postoperative acute VTE (all infrageniculate) developed in 5 patients (7%) who received postoperative CVTP vs no patients in the preoperative CVTP group (p¼0.06). There was no significant difference in bleeding complications between treatment groups. CONCLUSIONS: A small proportion of patients undergoing major colorectal surgery have acute preoperative VTE. There is a trend toward fewer VTE in patients treated with preoperative vs postoperative CVTP. There appears to be no significant difference in bleeding complications between preoperative or postoperative CVTP. The study is ongoing to prevent type 2 error. The Need for Nigro: Adherence to Anal Cancer Treatment Guidelines Saves Sphincters Christian P Probst, MD, Christopher T Aquina, MD, Kristin N Kelly, MD, James C Iannuzzi, MD, MPH, Aaron S Rickles, MD, MPH, Katia Noyes, PhD, MPH, John RT Monson, MD, FACS, Fergal J Fleming, MD Surgical Health Outcomes and Research Enterprise, Rochester NY, University of Rochester Medical Center, Rochester, NY INTRODUCTION: Chemoradiation is recommended as first-line treatment for non-disseminated anal carcinoma by the National Comprehensive Cancer Network (NCCN) guidelines, with surgery reserved for cases failing initial treatment. This study assesses national adherence to guidelines, identifying factors associated with
ª 2014 by the American College of Surgeons Published by Elsevier Inc.
METHODS: Patients with clinical stage I through III anal squamous cell carcinoma were selected from the 2003-2011 National Cancer Data Base. Adherence to NCCN guidelines was defined as initial treatment with chemoradiation for local disease, with the option for local excision in stage 1. Patient and systemic factors associated with guideline non-adherence and rate of abdominoperineal resection (APR) were examined using univariate analysis and multivariable logistic regression. Factors with a p-value<0.2 were included in the final models. RESULTS: Of 22,043 patients, 71% of patients receiving recommended initial treatment and 704 (3.2%) underwent APR. On multivariable analysis, factors associated with not receiving recommended treatment were age over 70 y, male sex, African American ethnicity, Medicaid or Medicare insurance, increasing comorbidity burden and facility geography (Table). Patients who did not receive appropriate treatment were twice as likely to undergo APR (OR¼2.47, p<0.001) compared to those who did receive recommended treatment. Table 1. Factors associated with receipt of NCCN guideline therapy in Stage I-III anal carcinoma Factor
Age 70 y (ref, 50 y) Male sex African-American (ref, white) Comorbidity Score 2 (ref, 0-1) Facility location (ref, Northeast) South West Mountain Pacific
Not treated, %
OR (95% CI)
p Value
41.5 31.7
2.01 (1.80-2.25) 1.21 (1.13-1.30)
<0.001 <0.001
32.9
1.25 (1.13-1.40)
<0.001
34.3
1.19 (1.05-1.35)
0.008
24.9 29.8 44.3 28.5 29.9
1.30 1.99 1.32 1.30
(1.08-1.57) (1.66-2.38) (1.07-1.61) (1.11-1.52)
0.005 <0.001 0.008 0.001
CONCLUSIONS: Nearly 1 in 3 patients did not receive guidelineadherent treatment. These patients are twice as likely to undergo permanent colostomy. Despite slight improvement over time, many patients still go without appropriate treatment. This suggests a need to examine barriers to multidisciplinary care of anal cancer patients. Risk Factors and Consequences of Anastomotic Leaks after Colectomy Emily F Midura, MD, Dennis J Hanseman, PhD, Bradley R Davis, MD, FACS, Janice F Rafferty, MD, FACS, Daniel E Abbott, MD, Shimul A Shah, MD, FACS, Ian M Paquette, MD, FACS University of Cincinnati College of Medicine, Cincinnati, OH INTRODUCTION: Anastomotic leak (AL) is one of the most feared complications after colectomy. We aimed to identify risk factors for
S103
http://dx.doi.org/10.1016/j.jamcollsurg.2014.07.244 ISSN 1072-7515/14
S104
J Am Coll Surg
Surgical Forum Abstracts
AL on a national level and to quantify the additional morbidity and mortality experienced by patients with AL. METHODS: We performed a retrospective analysis of the 2012 NSQIP colectomy procedure targeted database, including all patients who underwent a segmental colectomy with anastomosis for colon cancer, diverticulitis, inflammatory bowel disease, or benign polyp. AL was defined as any patient with either “minor leak requiring percutaneous intervention,” or “major leak requiring laparotomy”. Multivariate logistic regression models were constructed to identify predictors of AL and quantify the impact of AL on postoperative outcomes. RESULTS: 13,684 patients were studied with an overall leak rate of 3.8% (segmental colectomy: 2.6% laparoscopic vs 4.8% open, anterior resection: 4.5% laparoscopic vs 4.9% open). Male sex, open approach, operative time, pelvic anastomosis, steroid use and smoking were associated with AL (Table). AL patients experienced increased LOS (13 vs 5 days p<0.001) and mortality (6.8% vs 1.6% p<0.001). AL patients were more likely to be readmitted (43.5% vs 8.3%, p<0.001) and 4.6 times more likely to be readmitted more than once in 30 days (p<0.001). AL patients were 37 times more likely to require multiple returns to the operating room as a complication of the primary procedure (p<0.001). Factors Associated with Anastomotic Leak after Colectomy Male sex Open approach OR time > 3 h Pelvic anastomosis Preoperative steroids Smoking
Odds Ratio
95% CI
p Value
1.41 1.72 1.58 1.30 1.57 1.57
1.13-1.75 1.28-2.31 1.25-1.98 1.01-1.69 1.06-2.32 1.21-2.03
0.003 <0.001 <0.001 0.05 0.02 <0.001
CONCLUSIONS: This is the first national study to identify patient and operative factors associated with AL after colectomy. Patients with AL are more likely to require multiple readmissions and multiple returns to the operating room. Source-Dependent Mortality Differences in Gastric Bypass Surgery: Do We Really Know Who’s Dead? Christopher A Guidry, MD, Stephen W Davies, MD, MPH, Amani D Politano, MD, Robert G Sawyer, MD, FACS, Bruce D Schirmer, MD, FACS, Margaret C Tracci, MD, FACS, Peter T Hallowell, MD, FACS University of Virginia, Charlottesville VA INTRODUCTION: The number of patients seeking bariatric surgery is growing yearly highlighting the need for accurate and reliable outcomes reporting. However, given the regionalization of bariatric surgery, patients are easily lost to follow up making this task difficult. Our hypothesis is that local mortality data underestimates mortality rates. METHODS: We identified a cohort of GBP patients and propensity-matched controls between January 1, 2002 and December 31,
2003. Longitudinal mortality data was acquired on the same cohort from three separate sources: our local electronic medical record (EMR), a regional vital statistics registry (Reg), and the social security death master file (DMF). Agreement between these sources was assessed using McNemar’s test. Survival was assessed with KaplanMeier analysis. RESULTS: We identified a cohort of 802 propensity-matched patients (1:1 match). The combined mortality rate was 9.6% (n¼ 77). The EMR identified 20 deaths, underestimating mortality by 74% (p-value <0.001; Kappa ¼ 0.39). The regional registry identified 61 deaths (20.7% underestimate, p-value <0.001; Kappa ¼ 0.87). The DMF missed only one patient (1.2% underestimate, Kappa ¼ 0.99). The EMR was the only source that failed to detect a significant difference in survival between cases and controls (p ¼ 0.11). CONCLUSIONS: We have demonstrated significant underestimates in mortality may occur depending the data source. We assert that local mortality data should never be reported due to its inherent inaccuracies. Similar inaccuracies may be present for other procedures as well. Regional-level data should be the minimum standard for reporting mortality from bariatric surgery. Unequal Burden of Injury at Level I Trauma Centers: The Case for Efficiency in Resource Allocation for Optimal Trauma Care Zain G Hashmi, MBBS, Syed Nabeel Zafar, MD, MPH, Adil A Shah, MD, Eric B Schneider, PhD, William R Leeper, MD, FRCSC, Elliott R Haut, MD, FACS, Edward E Cornwell, MD, FACS, Adil H Haider, MBBS, FACS Johns Hopkins University School of Medicine, Baltimore, MD INTRODUCTION: Trauma centers (TCs) are frequently designated and verified based on the availability of resources to optimally care for the injured. However, anecdotal evidence suggests that even between similarly-resourced facilities, some centers treat different proportions of specific injuries than others, raising concerns regarding efficiency of equal resource allocations. The objective of this study was to explore the existence of potential differences in the proportion of specific injuries treated at level I trauma centers. METHODS: We analyzed data from the National Trauma Data Bank 2007-2011. Patients 16 years of age, with blunt/penetrating injuries and an Injury Severity Score 9 admitted to level I trauma centers were included. The Barell Injury Diagnosis Matrix was utilized to characterize proportions of specific injuries treated at each center. TCs were then classified into proportional quintiles for each specific injury, which were then used to compare inter-quintile variations (lowest vs highest quintile). RESULTS: A total of 720,563 patients from 172 TCs were analyzed. Significant interquintile variations were observed for all cohorts (Table). The greatest variation was found between lowest and highest quintile TCs for penetrating (6.7-fold difference, p<0.01) and firearm injuries (9.4-fold difference, p<0.01). An
Randomized Prospective Study on Preoperative vs Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery: An Interim Analysis Karen Zaghiyan, MD, Harry C Sax, MD, Seth Felder, MD, Alexandra Gangi, MD, David Cossman, MD, Phillip R Fleshner, MD, FACS Cedars Sinai Medical Center, Los Angeles, CA INTRODUCTION: Current guidelines recommend chemical venous thromboprophylaxis (CVTP) to start either before colorectal surgery or within 24 hours after colorectal surgery. However, there are no studies comparing the incidence of venous thromboembolism (VTE) and bleeding complications between preoperative vs postoperative CVTP. METHODS: A randomized prospective study was performed on patients undergoing major colorectal surgery treated with heparin 5000 units subcutaneous every 8 hours either started before surgery (preoperative CVTP) or with 24 hours after surgery (postoperative CVTP). Duplex sonography was performed preoperatively, immediately postoperatively and on postoperative day 2 (POD2). Bleeding complications were also evaluated. RESULTS: 154 study eligible patients underwent preoperative screening duplex sonography. 4 patients (3%) had a preoperative acute VTE and were excluded. 2 patients were excluded after randomization because they did not undergo the planned operation. Of the 148 patients included in the analysis, 73 received preoperative CVTP and 75 received postoperative CVTP. There was no significant difference in demographic and surgical variables between treatment groups. Postoperative acute VTE (all infrageniculate) developed in 5 patients (7%) who received postoperative CVTP vs no patients in the preoperative CVTP group (p¼0.06). There was no significant difference in bleeding complications between treatment groups. CONCLUSIONS: A small proportion of patients undergoing major colorectal surgery have acute preoperative VTE. There is a trend toward fewer VTE in patients treated with preoperative vs postoperative CVTP. There appears to be no significant difference in bleeding complications between preoperative or postoperative CVTP. The study is ongoing to prevent type 2 error. The Need for Nigro: Adherence to Anal Cancer Treatment Guidelines Saves Sphincters Christian P Probst, MD, Christopher T Aquina, MD, Kristin N Kelly, MD, James C Iannuzzi, MD, MPH, Aaron S Rickles, MD, MPH, Katia Noyes, PhD, MPH, John RT Monson, MD, FACS, Fergal J Fleming, MD Surgical Health Outcomes and Research Enterprise, Rochester NY, University of Rochester Medical Center, Rochester, NY INTRODUCTION: Chemoradiation is recommended as first-line treatment for non-disseminated anal carcinoma by the National Comprehensive Cancer Network (NCCN) guidelines, with surgery reserved for cases failing initial treatment. This study assesses national adherence to guidelines, identifying factors associated with
ª 2014 by the American College of Surgeons Published by Elsevier Inc.
METHODS: Patients with clinical stage I through III anal squamous cell carcinoma were selected from the 2003-2011 National Cancer Data Base. Adherence to NCCN guidelines was defined as initial treatment with chemoradiation for local disease, with the option for local excision in stage 1. Patient and systemic factors associated with guideline non-adherence and rate of abdominoperineal resection (APR) were examined using univariate analysis and multivariable logistic regression. Factors with a p-value<0.2 were included in the final models. RESULTS: Of 22,043 patients, 71% of patients receiving recommended initial treatment and 704 (3.2%) underwent APR. On multivariable analysis, factors associated with not receiving recommended treatment were age over 70 y, male sex, African American ethnicity, Medicaid or Medicare insurance, increasing comorbidity burden and facility geography (Table). Patients who did not receive appropriate treatment were twice as likely to undergo APR (OR¼2.47, p<0.001) compared to those who did receive recommended treatment. Table 1. Factors associated with receipt of NCCN guideline therapy in Stage I-III anal carcinoma Factor
Age 70 y (ref, 50 y) Male sex African-American (ref, white) Comorbidity Score 2 (ref, 0-1) Facility location (ref, Northeast) South West Mountain Pacific
Not treated, %
OR (95% CI)
p Value
41.5 31.7
2.01 (1.80-2.25) 1.21 (1.13-1.30)
<0.001 <0.001
32.9
1.25 (1.13-1.40)
<0.001
34.3
1.19 (1.05-1.35)
0.008
24.9 29.8 44.3 28.5 29.9
1.30 1.99 1.32 1.30
(1.08-1.57) (1.66-2.38) (1.07-1.61) (1.11-1.52)
0.005 <0.001 0.008 0.001
CONCLUSIONS: Nearly 1 in 3 patients did not receive guidelineadherent treatment. These patients are twice as likely to undergo permanent colostomy. Despite slight improvement over time, many patients still go without appropriate treatment. This suggests a need to examine barriers to multidisciplinary care of anal cancer patients. Risk Factors and Consequences of Anastomotic Leaks after Colectomy Emily F Midura, MD, Dennis J Hanseman, PhD, Bradley R Davis, MD, FACS, Janice F Rafferty, MD, FACS, Daniel E Abbott, MD, Shimul A Shah, MD, FACS, Ian M Paquette, MD, FACS University of Cincinnati College of Medicine, Cincinnati, OH INTRODUCTION: Anastomotic leak (AL) is one of the most feared complications after colectomy. We aimed to identify risk factors for
S103
http://dx.doi.org/10.1016/j.jamcollsurg.2014.07.244 ISSN 1072-7515/14
S104
J Am Coll Surg
Surgical Forum Abstracts
AL on a national level and to quantify the additional morbidity and mortality experienced by patients with AL. METHODS: We performed a retrospective analysis of the 2012 NSQIP colectomy procedure targeted database, including all patients who underwent a segmental colectomy with anastomosis for colon cancer, diverticulitis, inflammatory bowel disease, or benign polyp. AL was defined as any patient with either “minor leak requiring percutaneous intervention,” or “major leak requiring laparotomy”. Multivariate logistic regression models were constructed to identify predictors of AL and quantify the impact of AL on postoperative outcomes. RESULTS: 13,684 patients were studied with an overall leak rate of 3.8% (segmental colectomy: 2.6% laparoscopic vs 4.8% open, anterior resection: 4.5% laparoscopic vs 4.9% open). Male sex, open approach, operative time, pelvic anastomosis, steroid use and smoking were associated with AL (Table). AL patients experienced increased LOS (13 vs 5 days p<0.001) and mortality (6.8% vs 1.6% p<0.001). AL patients were more likely to be readmitted (43.5% vs 8.3%, p<0.001) and 4.6 times more likely to be readmitted more than once in 30 days (p<0.001). AL patients were 37 times more likely to require multiple returns to the operating room as a complication of the primary procedure (p<0.001). Factors Associated with Anastomotic Leak after Colectomy Male sex Open approach OR time > 3 h Pelvic anastomosis Preoperative steroids Smoking
Odds Ratio
95% CI
p Value
1.41 1.72 1.58 1.30 1.57 1.57
1.13-1.75 1.28-2.31 1.25-1.98 1.01-1.69 1.06-2.32 1.21-2.03
0.003 <0.001 <0.001 0.05 0.02 <0.001
CONCLUSIONS: This is the first national study to identify patient and operative factors associated with AL after colectomy. Patients with AL are more likely to require multiple readmissions and multiple returns to the operating room. Source-Dependent Mortality Differences in Gastric Bypass Surgery: Do We Really Know Who’s Dead? Christopher A Guidry, MD, Stephen W Davies, MD, MPH, Amani D Politano, MD, Robert G Sawyer, MD, FACS, Bruce D Schirmer, MD, FACS, Margaret C Tracci, MD, FACS, Peter T Hallowell, MD, FACS University of Virginia, Charlottesville VA INTRODUCTION: The number of patients seeking bariatric surgery is growing yearly highlighting the need for accurate and reliable outcomes reporting. However, given the regionalization of bariatric surgery, patients are easily lost to follow up making this task difficult. Our hypothesis is that local mortality data underestimates mortality rates. METHODS: We identified a cohort of GBP patients and propensity-matched controls between January 1, 2002 and December 31,
2003. Longitudinal mortality data was acquired on the same cohort from three separate sources: our local electronic medical record (EMR), a regional vital statistics registry (Reg), and the social security death master file (DMF). Agreement between these sources was assessed using McNemar’s test. Survival was assessed with KaplanMeier analysis. RESULTS: We identified a cohort of 802 propensity-matched patients (1:1 match). The combined mortality rate was 9.6% (n¼ 77). The EMR identified 20 deaths, underestimating mortality by 74% (p-value <0.001; Kappa ¼ 0.39). The regional registry identified 61 deaths (20.7% underestimate, p-value <0.001; Kappa ¼ 0.87). The DMF missed only one patient (1.2% underestimate, Kappa ¼ 0.99). The EMR was the only source that failed to detect a significant difference in survival between cases and controls (p ¼ 0.11). CONCLUSIONS: We have demonstrated significant underestimates in mortality may occur depending the data source. We assert that local mortality data should never be reported due to its inherent inaccuracies. Similar inaccuracies may be present for other procedures as well. Regional-level data should be the minimum standard for reporting mortality from bariatric surgery. Unequal Burden of Injury at Level I Trauma Centers: The Case for Efficiency in Resource Allocation for Optimal Trauma Care Zain G Hashmi, MBBS, Syed Nabeel Zafar, MD, MPH, Adil A Shah, MD, Eric B Schneider, PhD, William R Leeper, MD, FRCSC, Elliott R Haut, MD, FACS, Edward E Cornwell, MD, FACS, Adil H Haider, MBBS, FACS Johns Hopkins University School of Medicine, Baltimore, MD INTRODUCTION: Trauma centers (TCs) are frequently designated and verified based on the availability of resources to optimally care for the injured. However, anecdotal evidence suggests that even between similarly-resourced facilities, some centers treat different proportions of specific injuries than others, raising concerns regarding efficiency of equal resource allocations. The objective of this study was to explore the existence of potential differences in the proportion of specific injuries treated at level I trauma centers. METHODS: We analyzed data from the National Trauma Data Bank 2007-2011. Patients 16 years of age, with blunt/penetrating injuries and an Injury Severity Score 9 admitted to level I trauma centers were included. The Barell Injury Diagnosis Matrix was utilized to characterize proportions of specific injuries treated at each center. TCs were then classified into proportional quintiles for each specific injury, which were then used to compare inter-quintile variations (lowest vs highest quintile). RESULTS: A total of 720,563 patients from 172 TCs were analyzed. Significant interquintile variations were observed for all cohorts (Table). The greatest variation was found between lowest and highest quintile TCs for penetrating (6.7-fold difference, p<0.01) and firearm injuries (9.4-fold difference, p<0.01). An