Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.

BACKGROUND & AIMS: Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. METHODS: We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS: By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS: TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

Major bile duct injury requiring operative reconstruction after laparoscopic cholecystectomy: a follow-on study.

BACKGROUND: Bile duct injury (BDI) after laparoscopic cholecystectomy (LC) has significant cost impact and is a significant source of morbidity and mortality. We undertook a population-based assessment of the national experience with BDI between 2001 and 2011 and compared this to our report for the prior decade. METHODS: Using the nationwide inpatient sample (NIS) for 2001-2011, we identified patients who underwent LC or partial cholecystectomy, with and without biliary reconstruction. Data were analyzed using methods that accounted for the hierarchical, stratified random sampling of the NIS. Both univariate modeling and multivariate modeling were performed. RESULTS: LCs increased from 71.1 % in 2001 to 79.0 % in 2011 (p < 0.0001). Annual mortality decreased from 0.56 to 0.38 % (p = 0.002). In 2001, 0.11 % of LCs were associated with biliary reconstruction versus 0.09 % in 2011 (p = 0.15) with rates ranging from 0.08 to 0.12 %. The need for reconstruction was associated with an average in-hospital mortality rate of 4.4 %. Mortality rates from LC remained consistent across the study period (average mortality, 0.10 %, p = 0.57). Under multivariate analysis, admission to rural or urban non-teaching centers was associated with a decreased rate of injury; the majority of major BDIs were admitted from clinic or outpatient settings. These results are consistent with results from the prior decade. Neither emergent admission nor race was associated with increased odds of BDI, and this differs from our prior analysis. CONCLUSION: LC continued to increase in utilization between 2001 and 2011. Although rates of BDI have decreased, the need for reconstruction continues to be associated with a significant mortality. In addition, mortality related to biliary reconstruction is also higher than previously published series and may reflect the complexity of managing biliary injury as well as the higher likelihood of these patients having comorbid conditions.

The Global Burden of Esophageal Cancer: A Disability-Adjusted Life-Year Approach.

INTRODUCTION: Esophageal cancer is the eighth most common cancer worldwide and the sixth leading cause of cancer-related deaths. As a significant cause of morbidity and mortality, its burden on society has yet to be fully characterized. The aim of this study is to examine its global burden through estimation of the disability-adjusted life years (DALYs) attributable to it. METHODS: Global incidence and mortality estimates for esophageal cancer were obtained from the International Agency for Research on Cancer GLOBOCAN 2008 database. DALYs were calculated, using methodology established by the World Health Organization. RESULTS: In 2008, 3,955,919 DALYs were attributed to esophageal cancer, at a global rate of 0.58 DALYs per 1000 people annually. Years of life lost (YLL) accounted for 96.8 % of DALYs, while years lived with disability (YLD) accounted for 3.2 %. 83.8 % of the global DALYs occurred in less-developed countries, with most accrued in Eastern Asia, comprising 50.9 % of the total. The highest rate of DALY accrual was in Southern Africa, at 1.62 DALYs per 1000 people annually. CONCLUSIONS: A substantial number of years of life were lost or affected by esophageal cancer worldwide in 2008, with the burden resting disproportionately on less-developed countries. Geographically, the greatest burden is in Eastern Asia. The vast majority of DALYs were due to YLL, rather than YLD, indicating the need to focus resources on disease prevention and early detection. Our findings provide an additional basis upon which to formulate global priorities for interventions that affect DALY reduction in esophageal cancer.

Abnormal myocardial blood flow in children with mild/moderate aortic stenosis.

OBJECTIVE: To quantify myocardial blood flow in infants and children with mild or moderate aortic stenosis using adenosine-infusion cardiac magnetic resonance. BACKGROUND: It is unclear whether asymptomatic children with mild/moderate aortic stenosis have myocardial abnormalities. In addition, cardiac magnetic resonance-determined normative myocardial blood flow data in children have not been reported. METHODS: We studied 31 infants and children with either haemodynamically normal hearts (n=20, controls) or mild/moderate aortic stenosis (n=11). The left ventricular myocardium was divided into six segments, and the change in average segmental signal intensity during contrast transit was used to quantify absolute flow (ml/g/minute) at rest and during adenosine infusion by deconvolution of the tissue curves with the arterial input of contrast. RESULTS: In all the cases, adenosine was well tolerated without complications. The mean pressure gradient between the left ventricle and the ascending aorta was higher in the aortic stenosis group compared with controls (24 versus 3 mmHg, p<0.001). Left ventricular wall mass was slightly higher in the aortic stenosis group compared with controls (65 versus 50 g/m², p<0.05). After adenosine treatment, both the absolute increase in myocardial blood flow (p<0.0001) and the hyperaemic flow significantly decreased (p<0.001) in children with mild/moderate aortic stenosis compared with controls. CONCLUSION: Abnormal myocardial blood flow in children with mild/moderate aortic stenosis may be an important therapeutic target.

Nomogram for predicting the benefit of neoadjuvant chemoradiotherapy for patients with esophageal cancer: a SEER-Medicare analysis.

BACKGROUND: The survival impact of neoadjuvant chemoradiotherapy (CRT) on esophageal cancer remains difficult to establish for specific patients. The aim of the current study was to create a Web-based prediction tool providing individualized survival projections based on tumor and treatment data. METHODS: Patients diagnosed with esophageal cancer between 1997 and 2005 were selected from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. The covariates analyzed were sex, T and N classification, histology, total number of lymph nodes examined, and treatment with esophagectomy or CRT followed by esophagectomy. After propensity score weighting, a log-logistic regression model for overall survival was selected based on the Akaike information criterion. RESULTS: A total of 824 patients with esophageal cancer who were treated with esophagectomy or trimodal therapy met the selection criteria. On multivariate analysis, age, sex, T and N classification, number of lymph nodes examined, treatment, and histology were found to be significantly associated with overall survival and were included in the regression analysis. Preoperative staging data and final surgical margin status were not available within the SEER-Medicare data set and therefore were not included. The model predicted that patients with T4 or lymph node disease benefitted from CRT. The internally validated concordance index was 0.72. CONCLUSIONS: The SEER-Medicare database of patients with esophageal cancer can be used to produce a survival prediction tool that: 1) serves as a counseling and decision aid to patients and 2) assists in risk modeling. Patients with T4 or lymph node disease appeared to benefit from CRT. This nomogram may underestimate the benefit of CRT due to its variable downstaging effect on pathologic stage. It is available at skynet.ohsu.edu/nomograms.

Initial surgical management of ulcerative colitis in the biologic era.

BACKGROUND: The initial minimum operation for ulcerative colitis is a total abdominal colectomy. Healthy patients may undergo proctectomy at the same time; however, for ill patients, proctectomy is delayed. Since the introduction of biologic medications in 2005, ulcerative colitis medical management has changed dramatically. OBJECTIVE: We examined how operative management for ulcerative colitis has changed from the prebiologic to biologic eras. DESIGN: We conducted a retrospective review of data on patients with ulcerative colitis who were included in the Nationwide Inpatient Sample database. SETTINGS: This study was conducted at a single university. PATIENTS: A total of 1,547,852 patients with ulcerative colitis who were admitted to a US hospital from 1991 to 2011 were included in the study. MAIN OUTCOME MEASURES: We examined patients whose initial operation consisted of total abdominal colectomy without proctectomy versus a total proctocolectomy with or without a pouch. We also examined which operation was done at the time of the construction of an ileoanal pouch. Patients who underwent colectomy and pouch construction in the same hospitalization were compared with those who received pouch formation at a subsequent hospitalization. RESULTS: Ulcerative colitis-related admissions rose by 170% during the years examined, and the number of patients who required total abdominal colectomy increased by 44%. Total abdominal colectomy increased by 15%, as opposed to total proctocolectomy (p < 0.001). Pouch construction at a subsequent operation increased by 16% (p = 0.002). Since 2008, total abdominal colectomy has surpassed total proctocolectomy as the most common initial surgical intervention for ulcerative colitis. LIMITATIONS: The Nationwide Inpatient Sample is a retrospective database, and we were limited to examining the variables within it. CONCLUSIONS: Total abdominal colectomy is currently the most common initial operation for patients with ulcerative colitis, and an ileoanal pouch is more frequently constructed at a subsequent hospitalization. These trends coincide with the initiation of biologic treatments and may imply that patients are acutely ill at the time of initial operation. Alternately, there may be surgeon-perceived bias of increased surgical risk or a shift in care to specialized surgeons for pouch construction.

Surgical portosystemic shunts in the era of TIPS and liver transplantation are still relevant.

BACKGROUND: The surgical portosystemic shunts (PSS) are a time-proven modality for treating portal hypertension. Recently, in the era of liver transplantation and the transjugular intrahepatic portosystemic shunts (TIPS), use of the PSS has declined. OBJECTIVES: This study was conducted to evaluate changes in practice, referral patterns, and short- and longterm outcomes of the use of the surgical PSS before and after the introduction of the Model for End-stage Liver Disease (MELD). METHODS: A retrospective analysis of 47 patients undergoing PSS between 1996 and 2011 in a single university hospital was conducted. RESULTS: Subgroups of patients with cirrhosis (53%), Budd-Chiari syndrome (13%), portal vein thrombosis (PVT) (26%), and other pathologies (9%) differed significantly with respect to shunt type, Child-Pugh class, MELD score and perioperative mortality. Perioperative mortality at 60 days was 15%. Five-year survival was 68% (median: 70 months); 5-year shunt patency was 97%. Survival was best in patients with PVT and worst in those with Budd-Chiari syndrome compared to other subgroups. Patency was better in the subgroups of patients with cirrhosis and other pathologies compared with the PVT subgroup. Substantial changes in referral patterns coincided with the adoption of the MELD in 2002, with decreases in the incidence of cirrhosis and variceal bleeding, and increases in non-cirrhotics and hypercoagulopathy. CONCLUSIONS: Although the spectrum of diseases benefiting from surgical PSS has changed, surgical shunts continue to constitute an important addition to the surgical armamentarium. Selected subgroups with variceal bleeding in well-compensated cirrhosis and PVT benefit from the excellent longterm patency offered by the surgical PSS.

A cross-sectional analysis of the prevalence of Barrett esophagus in otolaryngology patients with laryngeal symptoms.

BACKGROUND: Populations at risk for esophageal adenocarcinoma remain poorly defined. Laryngeal symptoms can be secondary to laryngopharyngeal reflux (LPR) and can occur without associated gastroesophageal reflux symptoms such as heartburn and regurgitation. GOAL: We sought to determine the prevalence of Barrett esophagus (BE) in otolaryngology patients with laryngeal symptoms±typical gastroesophageal reflux disease (GERD) symptoms. STUDY: We performed a cross-sectional study of otolaryngology clinic patients who reported laryngeal symptoms. Symptoms, medications, and exposure histories were obtained. Unsedated transnasal endoscopy was performed. Suspected BE was biopsied and confirmed histologically. Risk factors and prevalence of BE were assessed. RESULTS: Two hundred ninety-five patients were enrolled [73% male, median age 60 y (interquartile range 51 to 68 y)]. The overall prevalence of BE was 11.8% (n=33). Antisecretory medication use was present in 56% (n=156) of patients at enrollment. Compared with patients without BE, patients with BE were more likely to be male (P=0.01) and to report occupational lung injury (P=0.001). Duration, but not severity of laryngeal symptoms, significantly increased the odds of BE (odds ratio, 5.64; 95% confidence interval, 1.28-24.83; for a duration of symptoms >5 y). Of patients with BE, 58% (n=19) had coexisting LPR and GERD symptoms and 30% (n=10) had only LPR symptoms. Presence and size of hiatal hernia and length of columnar-lined esophagus were significant risk factors for BE. CONCLUSIONS: Long-standing laryngeal symptoms are associated with the presence of BE in otolaryngology patients. Patients with chronic laryngeal symptoms and no identifiable ear, nose, or throat etiology for those symptoms may benefit from endoscopic screening regardless of whether typical GERD symptoms are present.

Laparoscopic colectomy reduces morbidity and mortality in obese patients.

BACKGROUND: Obesity is a growing epidemic in the US and increases the difficulty of laparoscopic surgery. Randomized, controlled trials of laparoscopic vs. open colectomy have shown equivalence but often exclude obese patients thus not answering whether obese patients may specifically benefit from laparoscopy. We hypothesized that obese patients would benefit from use of laparoscopy for colectomy. METHODS: We used the National Surgical Quality Improvement Program database from 2005 to 2009 and chose elective laparoscopic and open segmental colectomy and ileocecal resections. We compared patients' demographics, comorbidities, and outcomes. We used multivariate models to assess for predictors of complications in obese patients. These models included demographics, comorbidities, and outcomes. RESULTS: 35,998 patients were identified who underwent elective colectomy with primary anastomosis. Forty-four percent of the included cases were laparoscopic and 31 % of patients had a BMI greater than 30 (obese). Obese patients were more likely to have diabetes, hypertension, prior percutaneous coronary intervention, and dyspnea on exertion. We constructed a new variable called any complication that included all complications except 30-day mortality. In our multivariate analysis, laparoscopic approach in obese patients independently decreased the relative risk of superficial (odds ratio (OR) 0.72, 95 % confidence interval (CI) 0.63-0.82) and deep (OR 0.44, CI 0.31-0.61) surgical site infections, intra-abdominal infection (OR 0.61, CI 0.49-0.78), dehiscence (OR 0.50, CI 0.35-0.69), pneumonia (OR 0.60, CI 0.44-0.81), failure to wean from the ventilator (OR 0.64, CI 0.47-0.87), renal failure (OR 0.58, CI 0.35-0.96), urinary tract infection (OR 0.62, CI 0.49-0.79), sepsis (OR 0.53, CI 0.43-0.66), septic shock (OR 0.65, CI 0.47-0.90), any complication (OR 0.61, CI 0.55-0.67) and 30-day mortality (OR 0.56, CI 0.31-0.98). CONCLUSIONS: Due to the significant decrease in the risk of morbidity and mortality, laparoscopic colectomy should be offered to obese patients whenever feasible.

Impact of comorbidity on outcomes and overall survival after open and minimally invasive esophagectomy for locally advanced esophageal cancer.

BACKGROUND: The aim of this study was to examine the impact of the Charlson Comorbidity Index-Grade (CCI-G) on predicting outcomes and overall survival after open and minimally invasive esophagectomy (MIE). METHODS: One hundred and forty-six patients who underwent esophagectomy between 1995 and 2011 for stage II and III cancer were selected and separated into open esophagectomy (Open) and MIE groups. Risk adjustment was performed using the CCI-G. The outcomes of interest were operative time, estimated blood loss (EBL), lymph node harvest, length of hospital stay (LOS), major complications, 30-day mortality, and overall survival. RESULTS: Sixty-four patients (44 %) underwent Open while 71 (49 %) had MIE. An additional (7 %) were converted and classified with MIE. There was no significant difference between MIE and Open in terms of operative time. MIE had less EBL (mean difference = 234 mL, p < 0.001), higher lymph node harvest (mean = 7.4 nodes, p < 0.001), and shorter LOS (median = 1.5 days, p = 0.02). Atrial arrhythmias were the most frequent complication, occurring in 33 % of patients in both the MIE and the Open group (p = 0.988). Thirty-day mortality was 2 % for MIE and 5 % for Open (p = 0.459). Five-year survival was 41 % for MIE and 33 % for Open (p = 0.513). Operative approach, age, gender, BMI, clinical stage, and neoadjuvant therapy did not have any significant effect on the outcomes or overall survival. CCI-G influenced outcomes with operative time, LOS, cardiovascular complication, and anastomotic leak rate, favoring CCI-G 0 compared to CCI-G 3. Overall survival was worse for CCI-G 1 in comparison with CCI-G 0 [hazard ratio (HR) 1.99, p = 0.027]. CONCLUSIONS: MIE is a safe alternative to open esophagectomy for the treatment of locally advanced esophageal cancer. The presence of comorbidities increased operative time, length of hospital stay, and postoperative complications while worsening overall survival.

Regional variation in prosthesis choice for aortic valve replacement in older patients.

BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate regional practice patterns regarding aortic valve replacement (AVR) by comparing bioprosthetic versus mechanical valve usage in patients aged > or = 65 years, and to determine whether the choice of valve type for AVR in these patients varied by geographic region. METHODS: The details were acquired of all mechanical and bioprosthetic AVRs performed in patients aged > or = 65 years between 1999 and 2006, as contained in the Florida State Inpatient Database. By using a small area analysis, the patients' zip codes were aggregated into hospital referral regions based on where they were most likely to receive AVR. The regional rates of both mechanical and bioprosthetic AVR were then determined. RESULTS: Of 23,925 AVRs performed during this period, 15,368 involved a bioprosthetic aortic valve and 8,557 a mechanical aortic valve. Statewide, 64% of AVRs in these patients involved a bioprosthesis. Regional rates of mechanical AVRs varied widely, from 10% to 81%. CONCLUSION: Substantial regional differences were identified in practice patterns for AVR in patients aged > or = 65 years. This suggested that provider preference, in addition to patient pathology, would often determine the type of valve implanted.

Utilization of laparoscopic colectomy in the United States before and after the clinical outcomes of surgical therapy study group trial.

OBJECTIVE: To evaluate the utilization of laparoscopic colectomy (LC) in the United States before and after prospective data supported its use for the treatment of colon cancer. METHODS: The Nationwide Inpatient Sample 2001-2003 [before Clinical Outcomes of Surgical Therapy (COST)] and 2005-2007 (after COST) was queried for elective colectomies for both benign and malignant disease. The COST trial was published in 2004; therefore, 2004 data were excluded. Univariate analyses including patient-specific, hospital-specific, and outcome variables were performed. Multivariate logistic regression models and subset analyses were used to evaluate these variables and operative approach by time frame. RESULTS: The query yielded 741,817 elective colectomies (684,969 open and 56,848 laparoscopic). The percentage of elective colectomies performed laparoscopically has increased over time. Laparoscopic colectomy for benign disease increased from 6.2% in 2001-2003 to 11.8% in 2005-2007, while those for colon cancer have increased by a larger percentage, 2.3% to 8.9%. In a multivariate model of patients with colon cancer, the odds ratio (OR) for having a laparoscopic approach after COST was 4.55 (confidence interval 3.81-5.44) compared with before COST. In contrast, for benign disease, the OR was 2.10 (confidence interval 1.79-2.46). Factors predictive of having a laparoscopic approach for cancer have changed very little over time: Patients are more likely to be male, insured, live in areas with the highest incomes, and undergo resection at urban teaching hospitals. CONCLUSIONS: Within 3 years after publication of the COST trial, the use of laparoscopic resection for colon cancer approached that of benign disease. However, almost 90% of cases are still performed open and utilization remains influenced by socioeconomic factors.

Specialized practice reduces inpatient mortality, length of stay, and cost in the care of colorectal patients.

OBJECTIVE: This study aimed to determine whether specialized surgeon practice improves clinical outcomes for major inpatient adult colorectal resections. DESIGN: The Nationwide Inpatient Sample was queried for elective colorectal resections performed from 2001 through 2007. Specialization was determined by first identifying surgeons' procedures as either colorectal or noncolorectal. Surgeons were then stratified as either a specialized surgeon, if colorectal cases comprised more than 75% of their caseload, or a nonspecialized surgeon if colorectal cases comprised less than 75%. MAIN OUTCOME MEASURES: The data points collected for these cases were: cost, length of stay, mortality, demographics, comorbidities, acuity of admission, hospital region, hospital location and teaching status, and primary payer information. Cost and length of stay were analyzed using a linear regression model with a log transformation for length of stay. A logistic regression analysis was performed for mortality. These models were adjusted for all other covariates including surgeon volume. RESULTS: A total of 13,925 surgeons performing 115,540 procedures were analyzed. Specialized surgeons comprised 4.6% of surgeons and performed 17.0% of resections. In multivariate analysis, specialized surgeons had a lower risk of mortality (OR 0.72; CI 0.57-0.90, P = .0044), decreased length of stay (absolute difference in days 0.23; CI 0.11-0.49, P = .0022), and similar hospital cost (absolute cost difference $420 less; CI $238 more to $1079 less, P = .211) compared with nonspecialized surgeons. Although cost was not significant at a 75% specialization cutoff, a relationship exists between lower hospitalization cost and increased surgeon specialization even when controlled for surgeon volume. CONCLUSIONS: Surgical specialization leads to reductions in mortality, hospital days, and cost for inpatient colorectal care.

Bile duct injury after laparoscopic cholecystectomy in hospitals with and without surgical residency programs: is there a difference?

BACKGROUND: Laparoscopic cholecystectomy (LC) is a common surgical procedure performed by surgical residents under the supervision of attending surgeons. There is a perception that performance of LC in a facility with a surgical training program provides a safer environment due to the presence of an assistant surgeon. The aim of this study was to compare the rate of bile duct injury, conversion, and mortality between hospitals with surgical residency programs (Group I) and hospitals without surgical training programs (Group II). METHODS: ICD-9 diagnosis and procedure codes were used to extract and analyze LC procedures from the Florida State Inpatient Database from 1997 through 2006. Bile duct injury was indicated by the code for a biliary reconstruction procedure performed during the same admission. Hospitals with surgical training programs were identified by participation in the Electronic Residency Application Service (ERAS) and verified by contact with each hospital. RESULTS: Between 1997 and 2006 there were 234,220 LCs identified, with 17,596 performed by Group I and 213,906 performed by Group II. Rate of BDI for Group I and Group II was 0.24 and 0.26%, respectively (p=0.71). There was a significant difference noted in emergency and urgent admission rates (65.6% for Group I vs. 77.2% for Group II; p<0.001) and conversion (9.1% for Group I vs. 7.5% for Group II; p<0.001). Mortality was 0.44% for Group I and 0.55% for Group II (p=0.060). CONCLUSION: Our data suggest that bile duct injury rates are not influenced by the presence of a surgical residency program. In addition, there was no significant difference in mortality for LC at hospitals with surgical residencies when compared to hospitals without surgical residencies. A significant difference was noted in admission type and conversion rate but this did not appear to affect the rate of bile duct injury.

Laparoscopic proctectomy after neoadjuvant therapy: safety and long-term follow-up.

PURPOSE: The oncologic value of laparoscopic proctectomy for rectal adenocarcinoma is uncertain. Long-term data, particularly in tumors at higher risk of recurrence, is lacking. This study evaluated short- and long-term outcomes in patients who underwent laparoscopic proctectomy for locally advanced cancer (transmural and/or node positive) after neoadjuvant chemoradiotherapy (CRT). METHODS: This is a retrospective cohort study of 50 consecutive patients with transmural and/or node-positive rectal cancer, from a single surgeon's practice, from 2001 to 2009. All patients were treated with neoadjuvant CRT. All cases were started laparoscopic or hand-assist. RESULTS: Of 50 patients, 58% were men, mean age was 60.9 years, and mean body mass index (BMI) was 26.3. The average distance of the tumor from the anal verge was 5.7 cm. All patients completed CRT, and the subsequent mean time to operation was 7.8 weeks. The conversion to open rate was 26%. Thirty-day mortality was 2%. Twenty-two percent had a complete response to CRT. Two patients had positive margins: one developed distant recurrence only, and the other died 2 years later without evidence of local recurrence. The average distal margin was 3.26 cm. The average lymph nodes resected was 11.9. Seven patients had an ileus that delayed discharge and one had a pelvic abscess. Median length of stay was 6 days. Three patients were readmitted within 30 days; all for dehydration. Mean follow-up was 2.72 years. According to Kaplan-Meier analysis, the 5-year local recurrence rate was 9.6%, and the distant recurrence rate was 31%. Five-year disease-specific survival was 80% and overall survival was 68%. CONCLUSIONS: Patients with locally advanced rectal cancer treated with neoadjuvant therapy can safely undergo laparoscopic proctectomy with a low rate of complications. Oncologic outcomes, including 5-year disease-free survival and local recurrence rates, are comparable to published reports of open proctectomy.

Trends in the surgical treatment of ulcerative colitis over time: increased mortality and centralization of care.

BACKGROUND: New medical therapies available to ulcerative colitis (UC) patients have influenced operative mortality for patients requiring colectomy. We sought to examine trends in treatment and outcome for UC patients treated surgically. METHODS: A review of 36,447 UC patients from the Nationwide Inpatient Sample was performed, comparing the pre-monoclonal antibody era (1990-1996) to the present-day era (2000-2006). Patients treated with total colectomy with ileostomy or proctocolectomy with ileal pouch were reviewed for outcome measures and practice setting (rural, urban non-teaching, urban teaching). Our main outcome measures were in-hospital mortality, length of stay, and total charges. RESULTS: Total colectomy (n = 30,362) was performed five times more often than proctocolectomy (n = 6,085). When comparing the two study periods, mortality after total colectomy increased 3.8% to 4.6% (p = 0.0003). This difference was primarily due to increasing mortality in later years; when 1995-1996 was compared to 2005-2006, mortality increased from 3.6% to 5.6% (p < 0.0001). There were no deaths in the proctocolectomy group (p < 0.0001). The distribution by practice setting shifted over the two study periods, decreasing in rural (7.0% to 4.8%) and urban non-teaching (43.7% to 28.4%) centers, and increasing in urban teaching centers (49.3% to 66.8%). The total inflation-adjusted charges per patient increased significantly ($34,638 vs. $43,621; p < 0.0001). CONCLUSIONS: The mortality rate after total colectomy is increasing, and the difference is accentuated in the years since widespread use of monoclonal antibody therapy. The care of these patients is being shifted to urban teaching centers and is becoming more expensive.

Effect of high product ratio massive transfusion on mortality in blunt and penetrating trauma patients.

BACKGROUND: Recent data suggest that massively transfused patients have lower mortality rates when high ratios (>1:2) of plasma or platelets to red blood cells (RBCs) are used. Blunt and penetrating trauma patients have different injury patterns and may respond differently to resuscitation. This study was performed to determine whether mortality after high product ratio massive transfusion is different in blunt and penetrating trauma patients. METHODS: Patients receiving 10 or more units of RBCs in the first 24 hours after admission to one of 23 Level I trauma centers were analyzed. Baseline physiologic and biochemical data were obtained. Univariate and logistic regression analyses were performed. Adjusted mortality in patients receiving high (≥ 1:2) and low (<1:2) ratios of plasma or platelets to RBCs was calculated for blunt and penetrating trauma patients. RESULTS: The cohort contained 703 patients. Blunt injury patients receiving a high ratio of plasma or platelets to RBCs had lower 24-hour mortality (22% vs. 31% for plasma, p = 0.007; 20% vs. 30% for platelets, p = 0.032), but there was no difference in 30-day mortality (40% vs. 44% for plasma, p = 0.085; 37% vs. 44% for platelets, p = 0.063). Patients with penetrating injuries receiving a high plasma:RBC ratio had lower 24-hour mortality (21% vs. 37%, p = 0.005) and 30-day mortality (29% vs. 45%, p = 0.005). High platelet:RBC ratios did not affect mortality in penetrating patients. CONCLUSION: Use of high plasma:RBC ratios during massive transfusion may benefit penetrating trauma patients to a greater degree than blunt trauma patients. High platelet:RBC ratios did not benefit either group.

Profoundly abnormal initial physiologic and biochemical data cannot be used to determine futility in massively transfused trauma patients.

BACKGROUND: Improvements in prehospital care and resuscitation have led to increases in the number of severely injured patients who are salvageable. Massive transfusion has been increasingly used. Patients often present with markedly abnormal physiologic and biochemical data. The purpose of this study was to identify objective data that can be used to identify clinical futility in massively transfused trauma patients to allow for early termination of resuscitative efforts. METHODS: A multicenter database was used. Initial physiologic and biochemical data were obtained, and mortality was determined for patients in the 5th and 10th percentiles for each variable. Raw data from the extreme outliers for each variable were also examined to determine whether a point of excessive mortality could be identified. Injury scoring data were also analyzed. A classification tree model was used to look for variable combinations that predict clinical futility. RESULTS: The cohort included 704 patients. Overall mortality was 40.2%. The highest mortality rates were seen in patients in the 10th percentile for lactate (77%) and pH (72%). Survivors at the extreme ends of the distribution curves for each variable were not uncommon. The classification tree analysis failed to identify any biochemical and physiologic variable combination predictive of >90% mortality. Patients older than 65 years with severe head injuries had 100% mortality. CONCLUSION: Consideration should be given to withholding massive transfusion for patients older than 65 years with severe head injuries. Otherwise we did not identify any objective variables that reliably predict clinical futility in individual cases. Significant survival rates can be expected even in patients with profoundly abnormal physiologic and biochemical data.

A predictive model for mortality in massively transfused trauma patients.

BACKGROUND: Improvements in trauma systems and resuscitation have increased survival in severely injured patients. Massive transfusion has been increasingly used in the civilian setting. Objective predictors of mortality have not been well described. This study examined data available in the early postinjury period to identify variables that are predictive of 24-hour- and 30-day mortality in massively transfused trauma patients. METHODS: Massively transfused trauma patients from 23 Level I centers were studied. Variables available on patient arrival that were predictive of mortality at 24 hours were entered into a logistic regression model. A second model was created adding data available 6 hours after injury. A third model evaluated mortality at 30 days. Receiver operating characteristic curves and the Hosmer-Lemeshow test were used to assess model quality. RESULTS: Seven hundred four massively transfused patients were analyzed. The model best able to predict 24-hour mortality included pH, Glasgow Coma Scale score, and heart rate, with an area under the receiver operating characteristic curve (AUROC) of 0.747. Addition of the 6-hour red blood cell requirement increased the AUROC to 0.769. The model best able to predict 30-day mortality included the above variables plus age and Injury Severity Score with an AUROC of 0.828. CONCLUSION: Glasgow Coma Scale score, pH, heart rate, age, Injury Severity Score, and 6-hour red blood cell transfusion requirement independently predict mortality in massively transfused trauma patients. Models incorporating these data have only a modest ability to predict mortality and should not be used to justify withholding massive transfusion in individual cases.

Specific abbreviated injury scale values are responsible for the underestimation of mortality in penetrating trauma patients by the injury severity score.

BACKGROUND: The Injury Severity Score (ISS) is widely used as a method for rating severity of injury. The ISS is the sum of the squares of the three worst Abbreviated Injury Scale (AIS) values from three body regions. Patients with penetrating injuries tend to have higher mortality rates for a given ISS than patients with blunt injuries. This is thought to be secondary to the increased prevalence of multiple severe injuries in the same body region in patients with penetrating injuries, which the ISS does not account for. We hypothesized that the mechanism-based difference in mortality could be attributed to certain ISS ranges and specific AIS values by body region. METHODS: Outcome and injury scoring data were obtained from transfused patients admitted to 23 Level I trauma centers. ISS values were grouped into categories, and a logistic regression model was created. Mortality for each ISS category was determined and compared with the ISS 1 to 15 group. An interaction term was added to evaluate the effect of mechanism. Additional logistic regression models were created to examine each AIS category individually. RESULTS: There were 2,292 patients in the cohort. An overall interaction between ISS and mechanism was observed (p = 0.049). Mortality rates between blunt and penetrating patients with an ISS between 25 and 40 were significantly different (23.6 vs. 36.1%; p = 0.022). Within this range, the magnitude of the difference in mortality was far higher for penetrating patients with head injuries (75% vs. 37% for blunt) than truncal injuries (26% vs. 17% for blunt). Penetrating trauma patients with an AIS head of 4 or 5, AIS abdomen of 3, or AIS extremity of 3 all had adjusted mortality rates higher than blunt trauma patients with those values. CONCLUSION: Significant differences in mortality between blunt and penetrating trauma patients exist at certain ISS and AIS category values. The mortality difference is greatest for head injured patients.