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To establish expert consensus regarding the domains and topics for senior surgery residents (PGY-4) to make critical decisions and assume senior-level responsibilities, and to develop the formative American College of Surgeons Senior Resident Readiness Assessment (ACS SRRA) Program.The American College of Surgeons (ACS) education leadership team conducted a focus group with surgical experts to identify the content for an assessment tool to evaluate senior residents' readiness for their increased levels of responsibility. After the focus group, national experts were recruited to develop consensus on the topics through three rounds of surveys using Delphi methodology. The Delphi participants rated topics using Likert-type scales and their comments were incorporated into subsequent rounds. Consensus was defined as ≥ 80% agreement with internal-consistency reliability (Cronbach's alpha) ≥ 0.8. In a stepwise fashion, topics that did not achieve consensus for inclusion were removed from subsequent survey rounds.The surveys were administered via an online questionnaire.Twelve program directors and assistant program directors made up the focus group. The 39 Delphi participants represented seven different surgical subspecialties and were from diverse practice settings. The median length of experience in general surgery resident education was 20 years (IQR 14.3-30.0) with 64% of the experts being either current or past general surgery residency program directors.The response rate was 100% and Cronbach's alpha was ≥ 0.9 for each round. The Delphi participants contributed a large number of comments. Of the 201 topics that were evaluated initially, 120 topics in 25 core clinical areas were included to create the final domains of ACS SRRA.National consensus on the domain of the ACS SRRA has been achieved via the modified Delphi method among expert surgeon educators. ACS SRRA will identify clinical topics and areas in which each senior resident needs improvement and provide data to residents and residency programs to develop individualized learning plans. This would help in preparing the senior residents to assume their responsibilities and support their readiness for future fellowship training or surgical practice.

This Guide to Statistics and Methods outlines the considerations when determining a budget for a clinical trial in preparation for submitting applications to various funding agencies.

Background With the introduction of stapling devices (SDs), the proportion of hand-sewn (HS) intestinal anastomoses (IAs) has declined. As more IAs are constructed with SDs, there are fewer opportunities for general surgery residents (GSRs) to acquire the skills for HS techniques during their training. Study Design Data for this study were extracted from an existing database of all IAs performed at the Department of Surgery of the Morristown Medical Center since 2003. For the purposes of this study, a 5.5-year timeframe was used between July 2006 and 2011, which contained 1659 IA operations on adult patients with resident involvement. GSRs of the 5-year general surgery residency program were grouped by postgraduate year (PGY) for further analysis. Results The number of all IAs created by each resident during the 5-year training was 67.2 on average. Most of these operations were done in the last 2 years of the training: 45.1% of all IAs in PGY5 and 37.3% of all IAs in PGY4. Of all, 1659 IAs performed in the study period, 711 (42.9% of total) were done laparoscopically and 948 (57.1% of all IAs) were done as open operations. Laparoscopic operations had a proportionally higher rate of SD use when compared to open cases (90.9% vs 82.4%). On average, each resident constructed 9.4 HS IAs (13.98% of all IAs) and 57.8 SD IAs (86.02% of total). Out of all anastomoses, ostomy reversals (30.7%) had the highest percentage of HS suturing followed by right colectomies (27.5%), ileal pouch-anal anastomoses and total colectomies and proctocolectomies (23.3%), small bowel resection (17.0%), and left colectomies (5.5%). Regardless of the location of the operation, stapled and sutured anastomoses had similar outcomes measured by the rate of anastomotic leaks. Residents used significantly more SDs in the creation of anastomoses than HS suturing in the PGY3, PGY4, and PGY5 years. We also documented that attending surgeons who are older more often used HS suturing than their younger colleagues when creating IAs. Conclusions The experiences of GSRs in IA operations are heavily weighted toward the use of SDs. There are select cases, however, when HS suturing can have an advantage over stapler use in anastomosis creation. Therefore, we believe that GSRs should continue learning, perfecting, and using the both techniques.

An excellent idea for a clinical trial will never get off the ground unless your vision for the importance of the information gained is shared by others who can afford to make your vision a reality. Your passion must be directed at enlisting a patron or patrons who have the resources to pay for your vision. They are willing to do so in the form of a grant if you can show how spending their money can enhance their mission to improve health care for an identifiable segment of the population or for specific disease or specific sufferer. Aligning your needs and their interests is the key beginning for a successful application. Choosing the right agency and applying on time with a well-written application that includes a meticulous protocol are all important elements for success. Getting the money to fund your work is an important accomplishment in its own right but using it effectively is equally important and your key to being funded in the future.

Physician scientists are naturally curious and adventurous. When it comes to finance, however, many otherwise savvy and capable individuals shy away from budgets and financial matters. In planning a clinical trial, however, the budget process is integral to the overall planning and execution of a clinical trial. Sometimes, the ideally constructed treatment arm or the ideal control group represents a financially unobtainable quest, but a surrogate end-point or a different comparison regarding variable type can yield sound answers and be within financial reach. An experienced clinical trialist has an eye on the budget from the very beginning, while the project is on the drawing table. Much in the same way that we emphasize early biostatistician involvement, financial issues should be thought of in lock-step with trial design. In this way, the process is much like building a home. In the design phase, we might have certain goals and wishes that are simply outside the affordability range and so we change the plans in some way to provide a great home and one that we can afford. The bulk of expenses in a clinical trial are generally related to personnel costs and the costs of non-routine clinical care. The latter is a variable cost that rises with the required sample size. In addition to these costs, it is important to remember in large, multicenter trials that travel and related expenses for training at each site and for a DSMB meeting at one or two pre-specified points in the trial must be accounted for in the budget. The last major component is the safe-guarding, storage and ultimately the analysis of the data. These costs balloon with increasing numbers of data points and so seeking only that data which you might reasonably need to render a solid conclusion is a cost control measure. The costs of analysis are partly borne within the personnel costs in the form of salary to biostatisticians, but some costs for analytical software, web-based collection, and cloud computing are all in addition to the professional input and represent substantial budget items in the modern era.

Background Tracheoesophageal fistula (TEF) is the most common congenital tracheal abnormality, frequently associated with esophageal atresia. Respiratory symptoms are associated with all types of TEF, even after surgical repair of the fistula. Gastroesophageal reflux (GER) with aspiration of gastric contents, structural instability of the airways (tracheomalacia), abnormal respiratory epithelium, abnormal esophageal motility, recurrent TEF, and esophageal stenosis contribute to postsurgical complications. Methods We review 7 patients between 4 and 14 years of age with a history of TEF repair and persistent or worsening respiratory symptoms despite conventional airway clearance techniques and treatment of GER. Results Bronchoscopic evaluation in all 7 patients revealed tracheomalacia and a diverticulum on the posterior wall of the trachea at the fistula repair site. Conclusion We hypothesize that the diverticula impaired airway clearance and contributed to persistent respiratory symptoms. Possible mechanisms for the diverticulum contributing to poor airway clearance include facilitating the pooling of secretions and acting as a "barrier" to the lower airway clearance mechanism. The diagnosis of a diverticulum should be considered early in patients with persistent respiratory symptoms after management of GER and tracheomalacia. Early obliteration of tracheal diverticula might improve respiratory status in some patients.

Perforated necrotizing enterocolitis is a major cause of morbidity and mortality in premature infants, and the optimal treatment is uncertain. We designed this multicenter randomized trial to compare outcomes of primary peritoneal drainage with laparotomy and bowel resection in preterm infants with perforated necrotizing enterocolitis.We randomly assigned 117 preterm infants (delivered before 34 weeks of gestation) with birth weights less than 1500 g and perforated necrotizing enterocolitis at 15 pediatric centers to undergo primary peritoneal drainage or laparotomy with bowel resection. Postoperative care was standardized. The primary outcome was survival at 90 days postoperatively. Secondary outcomes included dependence on parenteral nutrition 90 days postoperatively and length of hospital stay.At 90 days postoperatively, 19 of 55 infants assigned to primary peritoneal drainage had died (34.5 percent), as compared with 22 of 62 infants assigned to laparotomy (35.5 percent, P=0.92). The percentages of infants who depended on total parenteral nutrition were 17 of 36 (47.2 percent) in the peritoneal-drainage group and 16 of 40 (40.0 percent) in the laparotomy group (P=0.53). The mean (+/-SD) length of hospitalization for the 76 infants who were alive 90 days after operation was similar in the primary peritoneal-drainage and laparotomy groups (126+/-58 days and 116+/-56 days, respectively; P=0.43). Subgroup analyses stratified according to the presence or absence of radiographic evidence of extensive necrotizing enterocolitis (pneumatosis intestinalis), gestational age of less than 25 weeks, and serum pH less than 7.30 at presentation showed no significant advantage of either treatment in any group.The type of operation performed for perforated necrotizing enterocolitis does not influence survival or other clinically important early outcomes in preterm infants. (ClinicalTrials.gov number, NCT00252681.).

The head ultrasound (US) is used extensively at most extracorporeal membrane oxygenation (ECMO) centers to screen for intracranial pathology in the ECMO candidate. Daily head US examinations are obtained in patients on ECMO to detect the emergence of intracranial hemorrhage (ICH). The authors asked whether these serial studies could be correlated with more definitive diagnostic studies, such as computed tomography (CT) and magnetic resonance imaging (MRI) scans, autopsy data, or the long-term neurodevelopmental status, to discern the predictive value of these daily examinations. Seventy-four consecutively treated neonates with reversible respiratory failure refractory to conventional support met institutional criteria for placement on ECMO. In addition to a pre-ECMO US, daily real-time portable head US images were evaluated for changes in echotexture, ventricular configuration, and extraaxial fluid. Follow-up CT and MRI scans were evaluated for the presence of hemorrhagic or ischemic lesions. Autopsy data were obtained from nonsurvivors. Survivors were examined by a neurodevelopmental specialist at regular intervals and classified as normal or delayed for chronological age. In this series of 74 patients, CT MRI scanning and autopsy data demonstrated structural injury in 19 patients; there were 16 ischemic infarctions and three hemorrhages. The incidence of hemorrhage in this series was considerably lower than that previously reported. Ten of the 19 patients had serial head US findings demonstrating a progression from focal increases in echotexture to diffuse effacement of cerebral architecture. In the remaining nine, serial head US examinations did not show injury. An additional 10 children had a clear delay in neurological development despite no evidence of anatomic injury on serial head US examinations or CT MRI scanning. The mortality was 42% for neonates who had either an abnormal head US result or an abnormal result on the follow-up neuroimaging study. In the 43 patients without evidence of such injury, the mortality was 16%.

Purpose: This study evaluates the multistaged extrathoracic esophageal elongation procedure performed on 12 babies with long gap esophageal atresia over 15 years. Methods: Eight babies had pure esophageal atresia, 2 had proximal tracheoesophageal fistula (TEF), and 2 had distal TEF. The gaps ranged between 2 and 7 vertebral bodies. Proximal esophagostomy, TEF ligation, and gastrostomy were performed initially. The proximal esophagus is elongated 2 to 3 cm each time by translocating the esophagostomy distally along the anterior chest wall at 2- to 3-month intervals. Sham-fed milk is collected in an ostomy bag and refed via the gastrostomy. The definitive esophageal reconstruction is performed at 5 to 24 months of age. Results: Only one elongation was required in 4 babies, 2 were needed in 5, 3 in 2, and 5 in 1 patient. All patients tolerated sham feeding well. After esophageal restoration, 3 patients had minor leakage. All (12 of 12) patients had anastomotic stenosis requiring multiple dilatations, of which, 3 needed resection of stricture. Eleven patients had gastroesophageal reflux that required fundoplication. Follow-up was possible in 11 patients for 4 months to 14 years after esophageal restoration. Seven early patients are eating normally. Conclusion: Multistaged extrathoracic esophageal elongation is effective in stretching the proximal esophagus to bridge 2 to 7 vertebral bodies. J Pediatr Surg 36:1725-1727. Copyright © 2001 by W.B. Saunders Company.

Accessory spleens are found most commonly at the splenic hilum, however, they rarely are symptomatic. An 18-year-old man presented with lower abdominal pain. Cross-sectional imaging studies with 3-dimensional reconstruction suggested the presence of a mass that was associated with the spleen. A nuclear medicine radioisotope scan confirmed that the mass was a pelvic accessory spleen. Laparoscopic excision was performed with excellent results. This accessory spleen was unusual in its size and location. Accessory spleens should be removed if symptomatic or if they are identified at splenectomy for hematologic disease.

Background We reviewed a single institution experience with extracorporeal membrane oxygenation (ECMO) in the perioperative management of cardiac transplantation. Methods Of all pediatric cardiac transplant candidates (1984-2003), patients requiring ECMO pretransplantation/posttransplantation were identified, with particular attention to use of ECMO as a bridge to transplantation. Parameters reviewed included proportionate survival, incidence of pre-ECMO cardiac arrest, ECMO duration, and United Network for Organ Sharing list time. Results Three hundred patients were listed for transplantation. Twenty-nine required ECMO: 18 pretransplant, 3 pretransplant and posttransplant, 6 posttransplant, and 2 for delayed acute rejection. There were 21 bridge-to-transplant candidates, of which 10 eventually transplanted with 60% survival; 11 not transplanted had no survivors ( P = .004). Thirteen of 21 had cardiac arrest pre-ECMO with 1 (8%) survivor; 8 of 21 had no arrest with 5 (63%) survivors ( P = .014). Mean ECMO duration and United Network for Organ Sharing list times between transplanted and not transplanted were not significant. Nine received ECMO posttransplantation for cardiopulmonary support; 5 (56%) of 9 survived. Two patients supported with ECMO for rejection-related cardiovascular collapse survived. Conclusion ECMO can bridge children to cardiac transplantation. Survival is significantly impaired in bridge-to-transplant candidates stratified by pre-ECMO cardiac arrest. ECMO can also help transition from cardiopulmonary bypass after transplantation and provide effective support during acute rejection.

Appendicitis is one of the most common causes of acute surgical disease in children and young adults. Parasites, however, are one of the uncommon etiologies. An 8-year-old girl and her 7-year-old sister presented with more than 2 months of chronic abdominal pain that became worse over a 1-week period before presentation. The 2 sisters presented 1 month apart. Both had similar symptomatology and physical examination findings. At operation, the surgical findings included an inflamed appendix with a cross section of the parasite Strongyloides. Strongyloides appendicitis has occurred almost exclusively in areas endemic to the parasite. Its environment is more common outside the United States but occasionally is seen in the Southeast region and in institutionalized individuals. The presentation of acute exacerbation of chronic abdominal pain coupled with the pathologic finding of Strongyloides in an acutely inflamed appendix, should alert the clinician of other possible cases. This increased index of suspicion will allow more prompt diagnosis and help avoid the morbidity of delayed operation.

METHODS: The Nationwide Inpatient Sample was retrospectively reviewed before (01/01/2001 to 06/30/2003) and after (1/1/2008 to 12/31/2010) the implementation of the ACGME duty-hour restrictions in teaching and non-teaching hospitals. Only emergent admissions for general surgical procedures were selected. In order to detect any association between duty-hour restrictions and patient outcomes in teaching hospitals, non-teaching hospitals were used as controls. Multivariate regression analysis was used after controlling for patient comorbidities, hospital factors, procedure types, and the magnitude of changes in outcomes between the two periods in both hospital settings.

Solid ovarian tumors are uncommon in the pediatric population, but when they occur, they are a major source of anxiety for the patient and her family. The pediatric surgeon will be relied on to diagnose these tumors because they usually present as abdominal pain with a mass. The diagnostic evaluation consists of a carefully obtained history and physical examination, ultrasound examination, serum assay for tumor markers, and further radiographic evaluation as indicated. Two thirds of malignant tumors in children are germ cell tumors, and most of these are dysgerminomas or endodermal sinus tumors. A multimodal, team-oriented approach to therapy is crucial. Reproductive organ-sparing surgery with salpingo-oopherectomy, ascites sampling, nodule biopsy, omentectomy, and contralateral ovarian biopsy as indicated, may be curative for stage I tumors; more advanced or highly aggressive tumors should be treated with cytoreduction surgery and will require platinum-based chemotherapy. Postinduction surgery is indicated for progressive or recurrent disease. One third of tumors are physiologically active stromal tumors that often become apparent because of hormonal effects. Epithelial tumors, common in the adult, are uncommon in children and are of mild to moderate malignant potential. Other miscellaneous tumors and benign lesions are less common.

Inhaled nitric oxide (NO) is effective as a selective pulmonary vasodilator, but its effects on uninjured lungs subjected to normoxia and hypoxia have not been fully studied. The authors sought the response of pulmonary vascular resistance (PVR) to inhaled NO in piglet lungs devoid of ischemic injury in a model of reversible pulmonary hypertension. If the changes were dose-responsive, the authors asked whether the PVR changes were related to normoxia or hypoxia, and hypothesized that the change would be more pronounced for hypoxia than normoxia. In situ isolated piglet lungs were prepared by occlusive tracheostomy and ligation of the ductus arteriosus and aorta. Cannulae positioned in the left atrium and pulmonary artery were connected to a standard extracorporeal membrane oxygenation (ECMO) circuit, and flow was increased to approximate cardiac output. After stabilization, piglets (aged 5 to 14 days, weighing 3.2 to 6.4 kg) were divided into two groups of four each: normoxic (Fio 2 0.30, normal PVR) and hypoxic (Fio 2 0.07, increased PVR). NO was administered at 10 to 80 parts per million (ppm) in increments of 10 ppm, for 5 minutes at each concentration, with a return to baseline before each new dose. Flow, pulmonary arterial (PA) and left atrial (LA) pressures were continuously monitored, from which PVR was calculated (PVR = [P PA − P LA ]/flow) and expressed as logΔPVR. Data were analyzed statistically by repeated measures of analysis of variance, comparing logΔPVR to baseline at each dose of NO, and comparing logΔPVR for normoxic and hypoxic lungs at each dose of NO. The authors found: (1) NO significantly decreased PVR at all doses in both normoxic and hypoxic piglet lungs ( P P

Prior studies of the association between oral contraceptives (OCs) and gallbladder disease (GBD) have yielded conflicting results. To clarify this association, a retrospective (historical) cohort study was performed on a very large data base including 1980 and 1981 Medicaid billing data from the states of Michigan and Minnesota in which 138,943 users of OCs were compared with 341,478 nonusers. The crude relative risk (RR) and 95% confidence interval (CI) for symptomatic GBD resulting in medical care was 1.14 (CI 1.09 to 1.20), with a clear dose-response (P less than 0.001). Age markedly modified the effect of OCs on GBD. The RR (CI) decreased from 3.1 (2.7 to 3.6) in women 15 to 19 years old to 1.2 (0.9 to 1.5) in women 40 to 44 years old, providing an explanation for previously conflicting reports. The effects of a number of other risk factors on GBD, some which have been controversial, were also confirmed. Adjustment for these did not change the results. In conclusion, OCs are risk factors for GBD, although the risk is of sufficient magnitude to be of potential clinical importance only in young women.To clarify the association between oral contraceptives (OCs) and gallbladder disease (GBD), a retrospective (historical) cohort study was performed with 1980 and 1981 Medicaid billing data from the states of Michigan and Minnesota in which 138,943 users of OCs were compared to 341,478 nonusers. There were 12,292 cases of GBD that required medical attention during the 2-year study, giving an overall prevalence rate of 25.6/1000 persons over the 2 years. Of the 138,943 OC users in this study, 3889 had GBD, giving a prevalence of 28.0/1000 persons in the 2-year study. Of the 341,478 nonusers, 8403 had GBD, resulting in a prevalence rate of 24.6/1000 persons in these 2 years. The overall prevalence rate in the unexposed subjects in Michigan was higher than that in Minnesota (28.5 vs. 12.3/1000 persons in the 2 year, respectively). This difference in prevalence by state may rest in part from differences in urbanization or to the known differences in racial distribution. Comparing Minnesota with Michigan, blacks are markedly underrepresented (5.9% versus 35.6%), Indians are overrepresented (3.9% versus 0.37%), and Orientals are overrepresented (5.7% versus 0.48%). Alternatively, this difference in prevalence by state may result from administrative dissimilarities between the 2 Medicaid programs, such as in differences in the number of diagnoses that can be provided per visit and the number of visits that can be included on each claim form. The results indicate that subsequent analyses need to be state specific or state adjusted. The crude relative risks confidence intervals for the effect of OCs on GBD were 1.14 overall, 1.08 for Michigan, and 1.39 for Minnesota. While the proportion of subjects using OCs decreased with advancing age, the prevalence of GBD increased steadily with age in both users and nonusers. Stratification by 5-year age intervals revealed age to be a strong modifier of the effect of OCs on GBD, with younger women at a higher risk of GBD from OCs than middle-aged women. The effects of a number of other risk factors on GBD also were confirmed. Adjustment for these failed to change the results. The relationship between OCs and GBD remained statistically significant even after age, state, and each confounding variable was controlled for logistic regression. In sum, OCs are risk factors for GBD, although the risk is of sufficient magnitude to be of potential clinical importance only in young women.