Operative Time Is Independently Associated With Morbidity in Pediatric Complicated Appendicitis.

INTRODUCTION: Complicated appendicitis is a common cause of morbidity in children. Studies have analyzed the risk factors in the surgical treatment of this pathology, including obesity and disease severity, but not operative time (OT). We hypothesize that OT is independently associated with increased morbidity for children with complicated appendicitis. METHODS: Data were extracted from the 2018 and 2019 National Surgical Quality Improvement Program-Pediatrics data sets. Patients aged 2-18 y who underwent laparoscopic appendectomy for complicated appendicitis were identified. Patient demographics, disease severity, and operative details were evaluated. Surgical site infections (SSIs), hospital length of stay (LOS), ≤30-d readmissions and reoperations, interventional radiologic drain (IR-drain) placement, pneumonia, and death were analyzed. Logistic and linear regression analyses were performed. RESULTS: A total of 8168 patients were analyzed, with a mean age of 9.96 ± 3.9 y and a mean weight of 41.2 ± 21.2 kg. The mean OT was 55.8 ± 24.9 min, with a mean LOS of 5.15 ± 3.37 d. For every 1-min increase in OT, there was an independently associated increase in the likelihood of any SSI (odds ratio [OR] = 1.01; 95% confidence interval [CI] 1.008-1.013), superficial SSI (OR = 1.01; 95% CI 1.004-1.020), organ-space SSI (OR = 1.01; 95% CI 1.008-1.013), IR-drain placement (OR = 1.01; 95% CI 1.008-1.013), and readmission (OR = 1.004; 95% CI 1.000-1.007). CONCLUSIONS: Prolonged OT is independently associated with greater likelihood of any SSI, superficial SSI, organ-space SSI, IR-drain placement, readmission and reoperation within 30 d, and longer hospital LOS. There is a need to determine modifiable factors that prolong OT to aid in the optimization of routine operations to reduce patient morbidity.

Surgical approaches in women with endometrial cancer with a body mass index greater than 35 kg/m2.

AIM: Endometrial cancer is often associated with obesity. We want to compare the outcomes of surgical staging according to the surgical approach in patients with a body mass index ≥35 kg/m2 . METHODS: A retrospective cohort study with 138 patients with endometrial cancer and body mass index ≥35 kg/m2 with different surgical staging routes: laparotomy (LPT; n = 94) and minimally invasive surgery (MIS): laparoscopy (LPC; n = 18) + robotic assisted laparoscopy (n = 26). RESULTS: Lymphadenectomy rate was similar in the three groups; there were no differences in the number of nodes removed. Decreased bleeding (P = 0.002) and hospital admission length (P < 0.001) was observed in the endoscopic group. Less early-postoperative complications were observed in the robotic approach (P = 0.007). Significant differences were not observed in recurrence-free survival or in overall survival. CONCLUSION: Minimal invasive surgical staging in obese women with endometrial cancer could represent the surgical route of choice because it decreases operative bleeding, hospital admission length and the early postoperative complication rate without compromising recurrence-free survival or overall survival.

Usefulness of retropubic tape for recurrent stress incontinence after transobturator tape failure.

INTRODUCTION AND HYPOTHESIS: This study was conducted to evaluate the effectiveness and safety of retropubic suburethral slings (TVT) to treat recurrent stress urinary incontinence (SUI) after transobturator tape (TOT) failure. METHODS: A descriptive study was performed among women with recurrent SUI treated at the Vall d'Hebron University Hospital between January 2006 and December 2009. All women were preoperatively evaluated to rule out complications of the first sling. Urodynamic testing was performed before and after the TOT procedure in all cases. Postoperative follow-up was performed at 1, 6, and 12 months and yearly thereafter. Outcomes were classified as cured, improved, or failed. RESULTS: Twenty-three women were operated on over the study period. The median time to reoperation was 12 months (range 6 to 34 months) and the median follow-up time was 36.1 months (range 7.8 to 60.2 months). Overall cure and improvement rates were 86.4% at 12 and 24 months and 75% at 36 months. Failure was found not to be related to time between both sling surgeries. Two cases of bladder perforation were recorded (8.7%). Postoperative complications were slight and self-limited. De novo urgency occurred in five cases (21.7%). CONCLUSIONS: TVT has been found to be effective to treat recurrent SUI after TOT failure in the present series with slight side effects.

Phase I study of BNC105P, carboplatin and gemcitabine in partially platinum-sensitive ovarian cancer patients in first or second relapse (ANZGOG-1103).

PURPOSE: The primary objective of this study was to determine the recommended dose of the vascular disrupting agent, BNC105P, in combination with gemcitabine and carboplatin in patients with ovarian cancer in first or second relapse with a minimum 4 month progression-free interval after last platinum. METHODS: Patients received carboplatin AUC4 on day 1 in combination with escalating doses of 800 or 1000 mg/m2 gemcitabine on days 1 and 8 and escalating doses of 12 or 16 mg/m2 BNC105P on days 2 and 9 every 21 days for a maximum for six cycles. Maintenance treatment with 16 mg/m2 BNC105P treatment continued for a maximum of six additional cycles. Patients were followed for safety and anti-tumor activity. RESULTS: Fifteen patients were enrolled in the study. Adverse events were most commonly of hematological origin. Dose-limiting toxicities (thrombocytopenia and neutropenia) occurred in two patients at the dose level of 800 mg/m2 gemcitabine, carboplatin AUC4 and 16 mg/m2 BNC105P. No dose-limiting toxicities were observed at a dose level of gemcitabine 1000 mg/m2, carboplatin AUC4 and BNC105P 12 mg/m2. BNC105P as a single agent was well tolerated at a dose of 16 mg/m2 in maintenance treatment. Ten patients (67%) achieved a complete or partial response according to CA125 and/or RECIST response criteria, four of 13 (31%) responded by RECIST alone. The median progression-free survival was 5.9 months. CONCLUSIONS: We have established that BNC105P 12 mg/m2 with gemcitabine 1000 mg/m2 and carboplatin AUC4 is the recommended dose level and has an acceptable toxicity profile. Further exploration of BNC105P in the ovarian cancer setting is planned.

Biliary complications after liver transplantation from maastricht category-2 non-heart-beating donors.

BACKGROUND: There are unresolved issues regarding the security of liver transplantation with non-heart-beating donors (NHBDs). Recently, an increased incidence of biliary complications, mainly intrahepatic ischemic-type biliary strictures, has been described after controlled NHBDs. METHODS: We studied the incidence and risk factors for biliary complications among uncontrolled NHBDs recipients compared with a large population of HBD recipients. RESULTS: Overall, 16.8% of patients in the HBD group and 41.7% of patients in the NHBD group suffered any type of biliary complication (P=0.66). However, the incidence of nonanastomotic biliary strictures was significantly greater in the NHBD group (P<0.001). Multivariate analysis showed that independent risk factors for nonanastomotic strictures were hepatic artery thrombosis (relative risk; 98.7) and receiving a liver from a NHBD (relative risk; 47.1). CONCLUSIONS: If this type of donors is accepted as a source of liver organs, the high incidence of biliary complications should be considered and efforts should be made to decrease ischemic injury.

Trans-obturator suburethral tape for female stress incontinence: a cohort of 254 women with 1-year to 2-year follow-up.

BACKGROUND: A clinical cohort study of 254 women undergoing trans-obturator surgery for stress urinary incontinence was conducted to assess the efficacy of the trans-obturator suburethral tape (TOT) after a follow-up of 1 year (251 evaluable patients) and 2 years (62 patients). RESULTS: Seventy-five patients had previous gynaecologic surgery. Overall cure and improvement rates were 82% at 6 and 12 months, and 90% at 24 months. The most favourable results were obtained in patients with occult incontinence and urethral hypermobility. The relative risk (RR) for failure in patients with a history of gynaecologic surgery was 3.3 (95% CI: 1.1-14.7). There were 8 cases of bladder perforation (3.1%) during the learning phase with the TOT procedure, 20 of urinary retention (7.9%) - in 1 patient the tape was released after 12 days of insertion - and 3 of tape erosion (1.2%). CONCLUSION: Results are encouraging but should be substantiated on a larger series over a longer follow-up.

Acetic acid allows effective selection of areas for obtaining biopsy samples in Barrett's esophagus.

OBJECTIVE: The aim of this study was to determine whether macroscopic changes resulting from acetic acid application on the surface of columnar-lined esophagus allow regular, nonmagnifying, endoscopic identification of areas presenting dysplasia and/or cancer in Barrett's esophagus. PATIENTS AND METHODS: A total of 100 patients (mean age, 53 years; range, 27-86 years) under surveillance because of short-segment (n=71) and long-segment (n=29) Barrett's esophagus, with no alterations of columnar-lined esophagus on standard endoscopy, were enrolled. After endoscopic examination, 3% acetic acid was sprayed on columnar-lined esophagus. The subsequent appearance of the mucosa was classified as: (1) Normal pattern: uniform reticulum along the entire columnar-lined esophagus. (2) Abnormal pattern: reticulum presenting areas of rough or irregular appearance. Biopsy samples were obtained from areas of normal and abnormal patterns, and the results of the corresponding histological studies were compared. All endoscopies were performed by the same investigator. RESULTS: The endoscopic appearance, after acetic acid application, corresponded to a normal pattern in 85% of cases and an abnormal pattern in 15%. The percentage of dysplasia and adenocarcinoma in biopsy specimens was significantly higher in patients with rough or irregular areas (86.7%) than in those with normal uniform reticulum (0%) (P< 0.001). Sensitivity for the identification of areas of dysplasia or adenocarcinoma was 100% (95% confidence interval: 71.7-100%). Specificity was 97.7% (95% confidence interval: 91.2-99.6%). CONCLUSIONS: This prospective study shows that acetic acid test is useful for standard, nonmagnifying, endoscopic detection of dysplasia and cancer in Barrett's esophagus.

A phase I/II study of pemetrexed and vinorelbine in patients with non-small cell lung cancer.

PURPOSE: Pemetrexed and vinorelbine are active antineoplastic agents in non-small cell lung cancer (NSCLC). Phase I objectives include maximum tolerated dose (MTD) and recommended phase II dose determination, and pharmacokinetics of the pemetrexed-vinorelbine doublet in locally advanced or metastatic solid tumor patients (pts). Phase II objectives include tumor response evaluation, efficacy, and toxicity for first-line treatment of advanced NSCLC. EXPERIMENTAL DESIGN: Phase I pts received pemetrexed (day 1, 300-700 mg/m2) and vinorelbine (days 1 and 8, 15-30 mg/m2) every 21 days. Pharmacokinetics determined at cycle 1. Beginning with dose-level 3, folic acid and Vitamin B12 supplementation were given. RESULTS: Thirty-one phase I pts were enrolled. MTD was pemetrexed 700 mg/m2 and vinorelbine 30 mg/m2; and recommended phase II dose was pemetrexed 500 mg/m2 and vinorelbine 30 mg/m2. When administered in combination, pemetrexed and vinorelbine pharmacokinetics were consistent with single-agent administration. Thirty-seven (36 chemonaive) phase II NSCLC pts received pemetrexed-vinorelbine. Evaluable tumor response was 40%, with intent-to-treat 38%. One drug-related death occurred from febrile neutropenia with Staphylococcal infection. Grade 3/4 hematologic toxicities were neutropenia (65%) and febrile neutropenia (11%), while prevalent grade 3/4 non-hematologic toxicity was fatigue (27%). CONCLUSION: The pemetrexed-vinorelbine combination is well tolerated and shows activity as first-line treatment in advanced NSCLC patients.

Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial.

PURPOSE: This phase III trial compared the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) plus carboplatin with solvent-based paclitaxel (sb-paclitaxel) plus carboplatin in advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: In all, 1,052 untreated patients with stage IIIB to IV NSCLC were randomly assigned 1:1 to receive 100 mg/m(2) nab-paclitaxel weekly and carboplatin at area under the concentration-time curve (AUC) 6 once every 3 weeks (nab-PC) or 200 mg/m(2) sb-paclitaxel plus carboplatin AUC 6 once every 3 weeks (sb-PC). The primary end point was objective overall response rate (ORR). RESULTS: On the basis of independent assessment, nab-PC demonstrated a significantly higher ORR than sb-PC (33% v 25%; response rate ratio, 1.313; 95% CI, 1.082 to 1.593; P = .005) and in patients with squamous histology (41% v 24%; response rate ratio, 1.680; 95% CI, 1.271 to 2.221; P < .001). nab-PC was as effective as sb-PC in patients with nonsquamous histology (ORR, 26% v 25%; P = .808). There was an approximately 10% improvement in progression-free survival (median, 6.3 v 5.8 months; hazard ratio [HR], 0.902; 95% CI, 0.767 to 1.060; P = .214) and overall survival (OS; median, 12.1 v 11.2 months; HR, 0.922; 95% CI, 0.797 to 1.066; P = .271) in the nab-PC arm versus the sb-PC arm, respectively. Patients ≥ 70 years old and those enrolled in North America showed a significantly increased OS with nab-PC versus sb-PC. Significantly less grade ≥ 3 neuropathy, neutropenia, arthralgia, and myalgia occurred in the nab-PC arm, and less thrombocytopenia and anemia occurred in the sb-PC arm. CONCLUSION: The administration of nab-PC as first-line therapy in patients with advanced NSCLC was efficacious and resulted in a significantly improved ORR versus sb-PC, achieving the primary end point. nab-PC produced less neuropathy than sb-PC.

Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial.

PURPOSE: The trial objectives were to identify the maximum-tolerated dose (MTD) of first-line gemcitabine plus nab-paclitaxel in metastatic pancreatic adenocarcinoma and to provide efficacy and safety data. Additional objectives were to evaluate positron emission tomography (PET) scan response, secreted protein acidic and rich in cysteine (SPARC), and CA19-9 levels in relation to efficacy. Subsequent preclinical studies investigated the changes involving the pancreatic stroma and drug uptake. PATIENTS AND METHODS: Patients with previously untreated advanced pancreatic cancer were treated with 100, 125, or 150 mg/m(2) nab-paclitaxel followed by gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 every 28 days. In the preclinical study, mice were implanted with human pancreatic cancers and treated with study agents. RESULTS: A total of 20, 44, and three patients received nab-paclitaxel at 100, 125, and 150 mg/m(2), respectively. The MTD was 1,000 mg/m(2) of gemcitabine plus 125 mg/m(2) of nab-paclitaxel once a week for 3 weeks, every 28 days. Dose-limiting toxicities were sepsis and neutropenia. At the MTD, the response rate was 48%, with 12.2 median months of overall survival (OS) and 48% 1-year survival. Improved OS was observed in patients who had a complete metabolic response on [(18)F]fluorodeoxyglucose PET. Decreases in CA19-9 levels were correlated with increased response rate, progression-free survival, and OS. SPARC in the stroma, but not in the tumor, was correlated with improved survival. In mice with human pancreatic cancer xenografts, nab-paclitaxel alone and in combination with gemcitabine depleted the desmoplastic stroma. The intratumoral concentration of gemcitabine was increased by 2.8-fold in mice receiving nab-paclitaxel plus gemcitabine versus those receiving gemcitabine alone. CONCLUSION: The regimen of nab-paclitaxel plus gemcitabine has tolerable adverse effects with substantial antitumor activity, warranting phase III evaluation.