Impact of Istradefylline on Levodopa Dose Escalation in Parkinson's Disease: ISTRA ADJUST PD Study, a Multicenter, Open-Label, Randomized, Parallel-Group Controlled Study.

INTRODUCTION: A higher levodopa dose is a risk factor for motor complications in Parkinson's disease (PD). Istradefylline (IST) is used as adjunctive treatment to levodopa in PD patients with off episodes, but its impact on levodopa dose titration remains unclear. The objective of this study was to investigate the effect of IST on levodopa dose escalation in PD patients with wearing-off. METHODS: This was a multicenter, open-label, randomized, parallel-group controlled study (ISTRA ADJUST PD) in which PD patients experiencing wearing-off (n = 114) who were receiving levodopa 300-400 mg/day were randomized to receive IST or no IST (control). Levodopa dose was escalated according to clinical severity. The primary endpoint was cumulative additional levodopa dose, and secondary endpoints were changes in symptom rating scales, motor activity determined by a wearable device, and safety outcomes. RESULTS: The cumulative additional levodopa dose throughout 37 weeks and dose increase over 36 weeks were significantly lower in the IST group than in the control group (both p < 0.0001). The Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I and device-evaluated motor activities improved significantly from baseline to 36 weeks in the IST group only (all p < 0.05). Other secondary endpoints were comparable between the groups. Adverse drug reactions (ADRs) occurred in 28.8% and 13.2% of patients in the IST and control groups, respectively, with no serious ADRs in either group. CONCLUSION: IST treatment reduced levodopa dose escalation in PD patients, resulting in less cumulative levodopa use. Adjunctive IST may improve motor function more objectively than increased levodopa dose in patients with PD. TRIAL REGISTRATION: Japan Registry of Clinical Trials: jRCTs031180248.

Intensive endoscopic resection for downstaging of polyp burden in patients with familial adenomatous polyposis (J-FAPP Study III): a multicenter prospective interventional study.

BACKGROUND: Total colectomy is the standard treatment for familial adenomatous polyposis (FAP). Recently, an increasing number of young patients with FAP have requested the postponement of surgery or have refused to undergo surgery. We aimed to evaluate the effectiveness of intensive endoscopic removal for downstaging of polyp burden (IDP) in FAP. METHOD: A single-arm intervention study was conducted at 22 facilities. Participants were patients with FAP, aged ≥ 16 years, who had not undergone colectomy or who had undergone colectomy but had ≥ 10 cm of large intestine remaining. For IDP, colorectal polyps of ≥ 10 mm were removed, followed by polyps of ≥ 5 mm. The primary end point was the presence/absence of colectomy during a 5-year intervention period. RESULTS: 222 patients were eligible, of whom 166 had not undergone colectomy, 46 had undergone subtotal colectomy with ileorectal anastomosis, and 10 had undergone partial resection of the large intestine. During the intervention period, five patients (2.3 %, 95 % confidence interval [CI] 0.74 %-5.18 %) underwent colectomy, and three patients died. Completion of the 5-year intervention period without colectomy was confirmed in 150 /166 patients who had not undergone colectomy (90.4 %, 95 %CI 84.8 %-94.4 %) and in 47 /56 patients who had previously undergone colectomy (83.9 %, 95 %CI 71.7 %-92.4 %). CONCLUSION: IDP in patients with mild-to-moderate FAP could have the potential to be a useful means of preventing colorectal cancer without implementing colectomy. However, if the IDP protocol was proposed during a much longer term, it may not preclude the possibility that a large proportion of colectomies may still need to be performed.

The impact of parental bariatric surgery and patient age on laparoscopic sleeve gastrectomy outcomes in adolescents.

BACKGROUND: Adolescent obesity is multifactorial, but parental history is the most significant risk factor. Laparoscopic sleeve gastrectomy (LSG) is part of the multidisciplinary approach to adolescent weight loss. OBJECTIVE: We aimed to evaluate the effects of parental history of bariatric surgery, as well as age at time of operation, on adolescents who underwent LSG at our institution. METHODS: We performed a retrospective review of patients, aged 10 to 19 years, who underwent LSG from January 2010 to December 2019. The adolescent bariatric surgical dataset maintained by our group was used to obtain patient demographics, weight, body mass index (BMI), and parental history of bariatric surgery. RESULTS: Among 328 patients, 76 (23.2%) had parents who had previously undergone bariatric surgery. These patients were significantly heavier by weight (p = 0.012) at the time of operation but had no difference in postoperative weight loss. When all patients were compared by age at operation (< 16 years, n = 102, ≥ 16 years, n = 226), there were few differences in outcomes. CONCLUSIONS: LSG is an effective approach to surgical weight loss in adolescents. Patient age should not be a barrier to weight loss surgery, especially among patients with a parental history of obesity. By intervening at a younger age, the metabolic sequelae of obesity may be reduced.

Evaluating the impact of adjunctive istradefylline on the cumulative dose of levodopa-containing medications in Parkinson's disease: study protocol for the ISTRA ADJUST PD randomized, controlled study.

BACKGROUND: Levodopa remains the most effective symptomatic treatment for Parkinson's disease (PD) more than 50 years after its clinical introduction. However, the onset of motor complications can limit pharmacological intervention with levodopa, which can be a challenge when treating PD patients. Clinical data suggest using the lowest possible levodopa dose to balance the risk/benefit. Istradefylline, an adenosine A2A receptor antagonist indicated as an adjunctive treatment to levodopa-containing preparations in PD patients experiencing wearing off, is currently available in Japan and the US. Preclinical and preliminary clinical data suggested that adjunctive istradefylline may provide sustained antiparkinsonian benefits without a levodopa dose increase; however, available data on the impact of istradefylline on levodopa dose titration are limited. The ISTRA ADJUST PD study will evaluate the effect of adjunctive istradefylline on levodopa dosage titration in PD patients. METHODS: This 37-week, multicenter, randomized, open-label, parallel-group controlled study in PD patients aged 30-84 years who are experiencing the wearing-off phenomenon despite receiving levodopa-containing medications ≥ 3 times daily (daily dose 300-400 mg) began in February 2019 and will continue until February 2022. Enrollment is planned to attain 100 evaluable patients for the efficacy analyses. Patients will receive adjunctive istradefylline (20 mg/day, increasing to 40 mg/day) or the control in a 1:1 ratio, stratified by age, levodopa equivalent dose, and presence/absence of dyskinesia. During the study, the levodopa dose will be increased according to symptom severity. The primary study endpoint is the comparison of the cumulative additional dose of levodopa-containing medications during the treatment period between the adjunctive istradefylline and control groups. Secondary endpoints include changes in efficacy rating scales and safety outcomes. DISCUSSION: This study aims to clarify whether adjunctive istradefylline can reduce the cumulative additional dose of levodopa-containing medications in PD patients experiencing the wearing-off phenomenon, and lower the risk of levodopa-associated complications. It is anticipated that data from ISTRA ADJUST PD will help inform future clinical decision-making for patients with PD in the real-world setting. TRIAL REGISTRATION: Japan Registry of Clinical Trials, jRCTs031180248 ; registered 12 March 2019.

It's time to deconstruct treatment-failure: A randomized controlled trial of nonoperative management of uncomplicated pediatric appendicitis with antibiotics alone.

BACKGROUND: Published data demonstrate that management of uncomplicated pediatric appendicitis with antibiotics-alone is safe and frequently successful. Randomized controlled trials (RCT) comparing antibiotics-alone to appendectomy are lacking, alongside insight into drivers of failure. We sought to validate the antibiotics-alone approach and identify barriers to success using an RCT design. METHODS: Patients aged 6-17 years with uncomplicated appendicitis were randomized to appendectomy or intravenous piperacillin/tazobactam for 24-48 h followed by 10 days of oral ciprofloxacin/metronidazole. Enrollment required symptoms <48 h, WBC<18, appendiceal diameter <11 mm, and radiographic absence of perforation. Lack of clinical improvement or persistently elevated WBC resulted in appendectomy. Primary outcomes were 1-year success rate of antibiotics-alone and quality-of-life measures. RESULTS: Among 39 children enrolled over 31 months, 20 were randomized to antibiotics-alone and 19 to surgery. At 1 year, 6 nonoperative patients underwent appendectomy (70% success). Four cases were not true antibiotic failures but instead reflected "pragmatic" challenges to executing nonoperative algorithms. Only 2 cases represented recurrent/refractory appendicitis, suggesting a 90% adjusted 1-year success rate. Parental PedsQL™ scores were similar between treatment cohorts (91.3 vs 90.2, P = 0.32). Children treated with antibiotics-alone had faster return to activity (2.0 vs 12 days, P = 0.001) and fewer parental missed work days (0.0 vs 2.5, P = 0.03). CONCLUSIONS: These data corroborate findings from non-randomized studies suggesting 70-90% of uncomplicated pediatric appendicitis can be treated with antibiotics-alone, with fewer disability days. Failures appear multifactorial, often reflecting practical hurdles and not antibiotic limitations. As surgeons consider nonoperative protocols for uncomplicated appendicitis, these data further inform the variability of treatment success. LEVEL OF EVIDENCE: 1; randomized controlled trial.

Chemoprevention with low-dose aspirin, mesalazine, or both in patients with familial adenomatous polyposis without previous colectomy (J-FAPP Study IV): a multicentre, double-blind, randomised, two-by-two factorial design trial.

BACKGROUND: The only established treatment for preventing colorectal cancer in patients with familial adenomatous polyposis (FAP) is colectomy, which greatly reduces patient quality of life. Thus, an alternative method is warranted. In this trial, we aimed to clarify the individual and joint effects of low-dose aspirin and mesalazine on the recurrence of colorectal polyps in Japanese patients with FAP. METHODS: This was a randomised, double-blind, placebo-controlled, multicentre trial with a two-by-two factorial design done in 11 centres in Japan. Eligible patients were aged 16-70 years and had a history of more than 100 adenomatous polyps in the large intestine, without a history of colectomy. Before the study, patients underwent endoscopic removal of all colorectal polyps of at least 5·0 mm in diameter. Randomisation was done with a minimisation method with a random component to balance the groups with respect to the adjustment factors of sex, age (<30 years vs ≥30 years), or smoking status at the time of entry. Patients and researchers were masked to the treatment group. There were four groups: aspirin (100 mg per day) plus mesalazine (2 g per day), aspirin (100 mg per day) plus mesalazine placebo, aspirin placebo plus mesalazine (2 g per day), or aspirin placebo plus mesalazine placebo. Treatment was continued until 1 week before 8 month colonoscopy. The primary endpoint was the incidence of colorectal polyps of at least 5·0 mm at 8 months and was assessed in the intention-to-treat population. Safety was assessed in the ITT population. We also did a per-protocol analysis including only patients who took at least 70% of the allocated study drug. This trial is registered with the UMIN Clinical Trials Registry, number UMIN000018736, and is complete. FINDINGS: Between Sept 25, 2015, and March 13, 2017, 104 patients were randomly assigned to receive either aspirin or aspirin placebo (n=52) or mesalazine or mesalazine placebo (n=52). Two patients withdrew from the aspirin plus mesalazine placebo group. 26 (50%) of 52 patients who received no aspirin had colorectal polyps of at least 5·0 mm at 8 months, as did 15 (30%) of the 50 patients who received any aspirin, 21 (42%) of the 50 patients who received no mesalazine, and 20 (38%) of the 52 patients who received any mesalazine. The adjusted odds ratio for polyp recurrence was 0·37 (95% CI 0·16-0·86) in the patients who received any aspirin and 0·87 (95% CI 0·38-2·00) in any who received mesalazine. The most common adverse events were grade 1-2 upper gastrointestinal symptoms in three (12%) of 26 patients who received aspirin plus mesalazine, one (4%) of 24 patients who received aspirin plus mesalazine placebo, and one (4%) of 26 patients who received mesalazine plus aspirin placebo. There was one grade 4 event in the mesalazine plus aspirin placebo group, but not related to the treatment. INTERPRETATION: Low-dose aspirin safely suppressed the recurrence of colorectal polyps larger than 5·0 mm in patients with FAP. These results suggest an effect of low-dose aspirin for FAP and could be an alternative method for preventing colorectal cancer in FAP. FUNDING: Japan Agency for Medical Research and Development.

Biliary Peritonitis Caused by Spontaneous Bile Duct Rupture in the Left Triangular Ligament of the Liver after Endoscopic Sphincterotomy for Choledocholithiasis.

Spontaneous bile duct rupture is a rare condition in adults, with only 70 cases reported. Increased bile duct wall pressure may lead to rupture and biliary peritonitis. In this patient, the bile duct ruptured in the hepatic left triangular ligament. A 91-year-old man underwent endoscopic retrograde cholangiopancreatography for choledocholithiasis and endoscopic retrograde biliary drainage (ERBD) placement. One week later, removal of the ERBD and common bile duct stones and an endoscopic sphincterotomy (EST) were performed. Four days later, the patient had abdominal pain, increased inflammatory reaction, and jaundice. Abdominal computed tomography showed ascites, bile duct dilatation and fluid collection under the liver (10 cm in diameter). Emergency surgery was performed to drain the fluid. On laparotomy, encapsulated biliary ascites was seen. To search for the site of the leak, after cholecystectomy, a tube (C-tube) was inserted into the common bile duct via cystic duct stump. Because of uncontrollable bleeding, after packing with surgical gauze, the operation was temporarily stopped. The next day, reoperation was performed. Intraoperative cholangiography with contrast dye revealed the perforation site in the left triangular ligament and a partial resection was performed. Bile excretion from the C-tube was subsequently observed, but the patient's jaundice did not improve. Although endoscopic retrograde cholangiopancreatography revealed that the EST site was normal, ERBD was placed again, and the jaundice gradually improved. Although EST was performed in this case, biliary peritonitis resulting from spontaneous bile duct rupture occurred. This case was very informative because biliary perforation may occur even after EST.

Variations in the management of adolescent adnexal torsion at a single institution and the creation of a unified care pathway.

PURPOSE: Adnexal torsion is a gynecologic emergency, requiring intervention for tissue preservation. At our institution, torsion is managed by pediatric surgeons or gynecologists. We evaluated differences between specialties to streamline evaluation for children with gynecological emergencies, develop a clinical pathway, and prevent care delays. METHODS: A retrospective review of adolescents undergoing intervention for adnexal torsion from 2004-2018 was performed. Differences in time to intervention, operation duration, the procedure performed, and length of stay (LOS) between the specialties were analyzed. RESULTS: Eighty-six patients underwent 94 operations for presumed adnexal torsion with 87 positive cases. Pediatric surgeons performed 60 operations and 34 cases were performed by gynecologists. Preservation of fertility was the goal in both cohorts and the rate of oophoropexy, cystectomy, and oophorectomy were similar between the cohorts (p = 0.14, p = 1.0, p = 0.39, respectively). There was no difference in intra-operative time (p = 0.69). LOS was shorter in the gynecology cohort (median 1 day [1-2] vs. 2 days [2-3], p > 0.001). CONCLUSIONS: Adnexal torsion is a time-sensitive diagnosis requiring prompt intervention for ovarian or fallopian tube preservation. A multidisciplinary institutional care pathway should be developed and implemented.

Preclinical evaluation of ultrasound-augmented needle navigation for laparoscopic liver ablation.

PURPOSE: For laparoscopic ablation to be successful, accurate placement of the needle to the tumor is essential. Laparoscopic ultrasound is an essential tool to guide needle placement, but the ultrasound image is generally presented separately from the laparoscopic image. We aim to evaluate an augmented reality (AR) system which combines laparoscopic ultrasound image, laparoscope video, and the needle trajectory in a unified view. METHODS: We created a tissue phantom made of gelatin. Artificial tumors represented by plastic spheres were secured in the gelatin at various depths. The top point of the sphere surface was our target, and its 3D coordinates were known. The participants were invited to perform needle placement with and without AR guidance. Once the participant reported that the needle tip had reached the target, the needle tip location was recorded and compared to the ground truth location of the target, and the difference was the target localization error (TLE). The time of the needle placement was also recorded. We further tested the technical feasibility of the AR system in vivo on a 40-kg swine. RESULTS: The AR guidance system was evaluated by two experienced surgeons and two surgical fellows. The users performed needle placement on a total of 26 targets, 13 with AR and 13 without (i.e., the conventional approach). The average TLE for the conventional and the AR approaches was 14.9 mm and 11.1 mm, respectively. The average needle placement time needed for the conventional and AR approaches was 59.4 s and 22.9 s, respectively. For the animal study, ultrasound image and needle trajectory were successfully fused with the laparoscopic video in real time and presented on a single screen for the surgeons. CONCLUSION: By providing projected needle trajectory, we believe our AR system can assist the surgeon with more efficient and precise needle placement.

Laparoscopic Versus Open Cholecystectomy in Pediatric Patients: A Propensity Score-Matched Analysis.

Background: As minimally invasive pediatric surgery becomes standard approach to many surgical solutions, access has become an important point for improvement. Laparoscopic cholecystectomy (LC) is the gold standard for many conditions affecting the gallbladder; however, open cholecystectomy (OC) is offered as the initial approach in a surprisingly high percentage of cases. Materials and Methods: The Kids' Inpatient Database (1997-2012) was searched for International Classification of Disease, 9th revision, Clinical Modification procedure code (51.2x). LC and OC performed in patients <20 years old were identified. Propensity score-matched analyses using 39 variables were performed to isolate the effects of race, income group, location, gender, payer status, and hospital size on the percentage of LCs and OCs offered. Cases were weighted to provide national estimates. Results: A total of 78,578 cases were identified, comprising LC (88.1%) and OC (11.9%). Girls were 1.6 (CI: 1.4, 1.7) times more likely to undergo LC versus boys. Large facilities were 1.4 (1.3, 1.7) times more likely to perform LCs than small facilities. Children in lower income quartiles were 1.2 (1.1, 1.3) times more likely to undergo LC compared with those in higher income quartiles. Rates of LC were not affected by race, hospital location, or payer status. Conclusions: Risk-adjusted analysis of a large population-based data set demonstrated evidence that confirms, but also refutes, traditional disparities to minimally invasive surgery access. Despite laparoscopic gold standard, OC remains the initial approach in a surprisingly high percentage of pediatric cases independent of demographics or socioeconomic status. Additional research is required to identify factors affecting the distribution of LC and OC within the pediatric population.

Laparoscopic Technique in the Management of High Anorectal Malformations: A Propensity Score-Matched Outcome Study Using a Large Inpatient Database.

Background: Posterior sagittal anorectoplasty (PSARP) has been the standard for management of children with high anorectal malformations (ARMs). Recently, there has been an increase in the use of laparoscopy in its management. We analyzed the outcomes of laparoscopically assisted anorectal pull-through (LAARP) compared to PSARP using a large inpatient database. Methods: Kids' Inpatient Database was analyzed for ARM (ICD-9-CM 751.2) between 1997 and 2012. Perineal fistulas and low/intermediate ARM were excluded. Propensity score (PS)-matched analyses were performed using 37 variables. Cases were weighted to provide national estimates. Results: Of the overall 29,106 cases, 7428 patients <2 years underwent surgical repair. LAARP was performed in 178 patients. Eighty-eight percent were male. Most were of Caucasian (n = 71; 45%), followed by Hispanic (n = 41; 26%) descent. Most were performed in 2009 and 2012 (n = 149; 83%). Most were covered by Medicaid (88; 49%), followed by private insurance (80; 45%). Median length of stay (LOS) was 4 (interquartile range = 3) days. The majority were performed in a children's hospital (n = 90; 88%). On PS-matched analysis, LAARP had shorter median LOS (4 [3]) compared to PSARP (6 [15]) days, P = .003. Rates of reoperation, wound infection, wound dehiscence, and mortality were unchanged between approaches. Cost was lower for LAARP (47,969 [49,450]) versus PSARP (56,110 [160,314]) U.S. dollar , P = .002, whereas total charges did not differ significantly. Conclusions: A minimal access approach to a complex procedure requires significant time and resources to be adopted as standard. PSARP is an important example, as increased availability of laparoscopy, and therefore, access to the procedure for patients will greatly affect resource utilization and recovery for the patient. As demonstrated, the LOS and cost is significantly lower for the LAARP procedure in comparison to the traditional approach. Future research will clarify boundaries to introducing the laparoscopic approach as a potential standard technique in the next decade.

Pattern of Biliary Disease Following Laparoscopic Sleeve Gastrectomy in Adolescents.

OBJECTIVE: The use of laparoscopic sleeve gastrectomy (LSG) has risen steadily as a treatment for adolescents with obesity. This study determined whether obstructive biliary complications after rapid, LSG-related weight loss occur similarly in adolescents compared with adults. METHODS: Between 2010 and 2019, 309 patients underwent LSG. Demographics and clinical factors, including pre- and perioperative BMI and weight changes, were included. RESULTS: Overall, 21 patients (7%) had post-LSG biliary disease (BD), of whom 13 presented with acute pancreatitis (AP) and 8 with biliary colic. No differences existed between those with BD (n = 21) and the remaining cohort (n = 288). Patients with BD were 16.3 (SD 2.4) years of age at LSG, with a preoperative BMI of 49.3 (SD 6.7) kg/m2 . Preoperative excess BMI loss was 7.1% (SD 11.3%). An ultrasound revealed gallstones (71%) and sludge or crystals (12%). Eighteen patients underwent cholecystectomy between 4 weeks and 29 months after LSG. CONCLUSIONS: Pediatric patients present with BD at a similar rate after LSG compared with adults. The majority of adolescents, however, manifest with AP. Thus, pancreatitis should be high on the differential diagnosis list when evaluating post-LSG abdominal symptoms. Additional studies are warranted to elucidate the pathophysiology of post-LSG AP for prevention in the future because its etiology may or may not be solely related to BD.

Lymph Node Sampling and Survival in Child and Adolescent Extremity Soft-Tissue Sarcoma.

BACKGROUND: The significance of lymph node sampling (LNS) on disease-specific survival (DSS) of extremity soft tissue sarcomas (STS) is unknown. We investigated the effect of LNS on DSS in child and adolescent extremity STS. MATERIALS AND METHODS: The Surveillance, Epidemiology, and End Results registry was queried for patients aged <20 y with extremity STS who underwent surgery. Patient demographics were collected and analyzed. RESULTS: A total of 1550 patients were included, with findings of 10-y DSS of 74% for all extremity STS and 49% for rhabdoymyosarcoma (RMS) (P < 0.005). LNS was associated with worse DSS in patients with extremity nonrhabdomyosacrcoma soft tissue sarcomas (79% versus 84%, P = 0.036). Conversely, LNS was associated with an improved DSS in patients with extremity RMS (64% versus 49%, P = 0.005). CONCLUSIONS: LNS is positively associated with an improved DSS in child and adolescent extremity RMS. Multivariate analysis found no correlation between DSS and LNS in child and adolescent extremity nonrhabdomyosarcoma soft tissue sarcomas.

Weekend vs. weekday appendectomy for complicated appendicitis, effects on outcomes and operative approach.

PURPOSE: We hypothesized that laparoscopic (LA) or open appendectomy (OA) outcomes in complicated appendicitis are associated with weekend vs. weekday procedure date. METHODS: We queried the Kids' Inpatient Database (1997-2012) for complicated (540.0, 540.1) appendicitis treated with LA or OA. Propensity score (PS)-matched analysis compared outcomes associated with weekend vs. weekday LA and OA. RESULTS: Overall, 103,501 cases of complicated appendicitis were identified. On 1:1 PS-matched analyses of complicated appendicitis, weekday OA had increased wound infection rates (odds ratio: 1.3) vs. weekend OA, p < 0.001. Weekend OA had higher pneumonia rates (1.4) and longer length of stay, but lower home healthcare requirement following discharge vs. weekday OA, p < 0.05. Weekend and weekday LA had no significant outcome differences. CONCLUSION: On a PS-matched comparison of appendectomies performed for complicated appendicitis on weekends and weekdays, procedure day is associated with different complication rates and resource utilization for OA. For LA, no weekend effect was noted for complicated appendicitis. To ensure the optimal patient care, prospective studies should be sought to identify causes of complications dependent on the day of procedure.

Incidence and outcomes of pediatric extremity melanoma: A propensity score matched SEER study.

BACKGROUND: There is a paucity of literature on treatment of melanoma in children with surgical management extrapolated from adult experience. The incidence and clinical outcomes of pediatric extremity melanoma were studied. METHODS: SEER registry was analyzed between 1973 and 2010 for patients <20years old with extremity melanoma. Multivariate and propensity-score matched analyses were performed to identify independent predictors of survival. RESULTS: Overall, 917 patients were identified with an age-adjusted incidence of 0.2/100,000 persons, annual percent change 0.96. Most had localized disease (77%), histology revealing melanoma-not otherwise specified (52%). Surgical procedures performed included wide local excision (50%), excisional biopsy (32%), lymphadenectomy (LA) (28%), and sentinel lymph node biopsy (SLNB) (15%). Overall, 30-year disease specific mortality was 7% with lower survival for extremity melanoma (90%), males (89%), nodular histology (69%), and distant disease (36%) (all P<0.05). Post-treatment multivariate analysis revealed localized disease (HR 9.76; P=0.006) as an independent prognosticator of survival; earlier diagnostic years 1988-1999 (HR 2.606; P=0.017) were a negative prognosticator of survival. Propensity-score matched analysis found no difference in survival between SLNB/LA vs no sampling for regional/distant disease. CONCLUSIONS: Pediatric extremity melanoma in SEER demonstrate no survival advantage between children undergoing sampling procedures vs no sampling for regional/distant disease. TYPE OF STUDY: Retrospective, prognostic study. LEVEL OF EVIDENCE: III.

Total retroperitoneal approach to aortic reconstruction: A novel technique for aorto-enteric fistulae and graft infections.

Aorto-enteric fistulae pose a challenging negative outcome of aortic intervention. Treatment involves graft excision, and recently, more enthusiasm has met in situ revascularization over extra-anatomic bypass. This has been traditionally performed through the transperitoneal approach via a midline abdominal incision. We propose an exclusively total retroperitoneal technique in managing this complication with regard to both the vascular and alimentary tract technical aspects of the procedure. This involves exclusion and bypass of the affected segment followed by en-mass resection of the affected segment with the duodenum, and finally, bowel anastomosis. We present a case of an aorto-enteric fistulae illustrating classical radiological findings treated via a flank incision and retroperitoneal technique after a temporizing endovascular stent placement at an outside institution. Peri-operative course was uneventful. The retroperitoneal approach has been shown to be equivalent to its transperitoneal counterpart in many aspects of treating aortic disease. It has also been shown to be superior in others, including but not limited to, faster return of bowel function, decreased respiratory complications, less blood loss and shorter length of stay in the intensive care unit (ICU) and hospital. We recommend adding this approach to every vascular surgeons operative armamentarium when it comes to managing aorto-enteric fistulae. This might be especially helpful in avoiding re-operative planes, thus minimizing blood loss and iatrogenic bowel injury, better aortic exposure, and adequate access to the duodenum.

Looped suture versus stapler device in pediatric laparoscopic appendectomy: a comparative outcomes and intraoperative cost analysis.

BACKGROUND: Appendiceal ligation during pediatric laparoscopic appendectomy (LA) may be performed using looped suture versus stapler. Controversy regarding the utility of either method exists. Clinical outcomes and cost analysis of LA with both methods were compared. METHODS: All pediatric LA were performed from fiscal years 2013 and 2014 by two pediatric surgeons. While one surgeon used looped suture, the other used stapler exclusively. chi-Square tests were performed to analyze associations. RESULTS: Two hundred thirty-eight cases were analyzed where looped suture versus stapler LA was performed in 46% and 54% of patients, respectively. Operating room costs were $317.10 and $707.12/person for looped suture and stapler LA, respectively (P<0.0001). Difference in cost of $390.02/person was attributed solely to ligation type. On bivariate analysis, rate of in-hospital complications, length of stay, return-to-ER and readmission within 30 days did not significantly differ between groups. CONCLUSION: A comparative analysis of looped suture versus stapler device during LA for pediatric appendicitis revealed that postoperative complications, length of stay, ER visits and readmissions were not significantly different. Looped suture LA was significantly more cost efficient than stapler LA. In pediatric appendicitis, appendiceal ligation during LA may be performed safely and cost effectively with looped suture versus stapler. TYPE OF STUDY: Cost effectiveness LEVEL OF EVIDENCE: III.

Open Versus Closed Reduction of Maxillary Fractures: Complications and Resource Utilization.

INTRODUCTION: Maxillary fractures are frequently managed depending on the surgeon's preferences, nature of the injury, presence of associated injuries, and comorbidities. Current literature advocates open reduction with plating versus closed techniques. However, data defining associated costs and complications comparing the 2 approaches remains lacking. METHODS: National Inpatient Sample (2006-2011) was examined for patients undergoing closed or open (76.73-76.74) reduction of maxillary fractures. Treatment-related complications were regarded as re-exploration of surgical site, hemorrhage, hematoma, seroma, wound infection, and dehiscence. RESULTS: Overall, 22,157 patients were identified. There were 18,874 closed and 3283 open procedures. Median age was 35 (interquartile range 27). Median length of stay (LOS) was 4 days. Median total charges were reported as 51486.80 USD. Males comprised 77% of the cohort. 68% of patients were Caucasian. Private payer/HMO accounted for the largest source of health care coverage (43.5%). On risk-adjusted multivariate analysis, there was no difference in surgical approach regarding incidence of postoperative complications. Males (2.73), nonprivate insurer payer (P = 0.002), South region (2.49), and transferred patients (2.55) had higher incidence of complications. Presence of chronic pulmonary disease (2.87) and coagulopathy (6.62) also increased risk of complications. Length of stay was shorter for open reduction (0.68) versus closed. Total charges were also less for open approach (0.37). CONCLUSION: While surgical approach did not affect complications, open approach favorably affected LOS and total charges. Future studies should focus on comorbidities, demographics, and associated injuries in relation to resource utilization for maxillary fractures. In current economic environment, such information might further dictate management options.

Success and safety of endoscopic retrograde cholangiopancreatography in children.

PURPOSE: Despite its diagnostic and therapeutic utility, endoscopic retrograde cholangiopancreatography (ERCP) is underutilized in children. METHODS: Patients younger than 18years undergoing ERCP from 2000 to 2014 at a children's hospital were identified. Patient characteristics and outcomes were evaluated. RESULTS: Overall, 215 ERCPs (78% therapeutic) were performed in 184 patients. Our cohort was 67% female, with a median age (IQR) of 14 (8) years. Common indications were choledocholithiasis, pancreatitis, sclerosing cholangitis, and postoperative complication. ERCP was performed with an adult duodenoscope in 96% of cases and with a pediatric duodenoscope in the remainder. Patients requiring a pediatric scope ranged in weight from 4.3 to 22.8kg, with ages from 2months to 6years. Cannulation was successful in 97% of cases. Findings included bile duct (BD) stones, BD dilatation, sclerosing cholangitis, BD stricture, pancreatic duct (PD) disruption, choledochal cyst, pancreas divisum, and BD leak. The most common therapeutic techniques were sphincterotomy, stone extraction, and stent. Complication rate was overall 10% with no deaths. On multivariate analysis, PD cannulation was associated with pancreatitis (OR 3.48), while age<4years (10.7), male gender (12.8), and precut sphincterotomy (31.3) were associated with hemorrhage (all p<0.05). CONCLUSION: ERCP can be performed successfully and safely in children with complication rates comparable to those in adults. The type of cannulation and patient age are independent risk factors for complications. LEVEL OF EVIDENCE: Treatment study-IV.

Deep Inferior Epigastric Perforator Versus Free Transverse Rectus Abdominis Myocutaneous Flap: Complications and Resource Utilization.

INTRODUCTION: Abdominal based breast reconstruction exists in a continuum from pedicled transverse rectus abdominis myocutaneous (TRAM) flap to deep inferior epigastric perforator (DIEP) free flap. DIEP flap has the advantage of complete rectus abdominis sparing during harvest, thus decreasing donor site morbidity. Aim of this study is to determine whether the surgical advantages of the DIEP flap impact postoperative outcomes versus the free TRAM flap (fTRAM). METHODS: We reviewed the Nationwide Inpatient Sample database (2010-2011) for all cases of DIEP and fTRAM breast reconstruction. Inclusion criteria were: female sex and patients undergoing DIEP or fTRAM total breast reconstruction. Male sex was excluded from the analysis. We examined demographic characteristics, hospital setting, insurance information, patient income, comorbidities, postoperative complications (including reoperation, hemorrhage, hematoma, seroma, myocardial infarction, pulmonary embolus, wound infection, and flap loss), length of stay, and total charges (TCs). Bivariate and multivariate analyses were performed to identify independent risk factors of increased length of stay and TCs. RESULTS: Fifteen thousand eight hundred thirty-six cases were identified. Seventy percent were white, 97% were insured, and 83% of patients were treated in an academic teaching hospital setting. No mortalities were recorded. The DIEP cohort was more likely to be obese (P = 0.001). Free TRAM cohort was more likely to suffer pneumonia (P < 0.001; odds ratio [OR], 3.7), wound infection (P = 0.001; OR, 1.7), and wound dehiscence (P < 0.001; OR, 4.3). Type of reconstruction did not appear to affect risk of revision, hemorrhage, hematoma, seroma, or flap loss. Total charges were higher in the DIEP group (P < 0.001). Multivariate analysis demonstrated that fTRAM was an independent risk factor for increased length of stay (P < 0.001; OR, 1.6), and DIEP was an independent risk factor for increased TCs (P < 0.01; OR, 1.5). There was no significant difference in postoperative complications. CONCLUSIONS: The fTRAM cohort was more likely to develop surgical site complications and have an increased length of stay, but TCs were higher for the DIEP group.