Ventral hernia repair using bioresorbable poly-4-hydroxybutyrate mesh in clean and contaminated surgical fields: a systematic review and meta-analysis.

PURPOSE: Use of biologic or synthetic mesh in hernia repair shifts is based on evolving evidence. Poly-4-hydroxybutyrate (P4HB) biosynthetic mesh is a potential alternative to biologic and synthetic mesh in ventral hernia repair (VHR). This meta-analysis assesses the efficacy of P4HB mesh in clean and contaminated surgical settings. METHODS: Two authors searched literature on PubMed, reviewing titles and abstracts of all articles to determine inclusion eligibility. Post-operative data were compared via transformation method to convert the proportion of patients with the outcome of interest into a suitable quantity for random-effects synthesis using STATA software. RESULTS: Initial search yielded 287 citations. Six studies were included and categorized on whether hernia repairs were conducted in clean (CDC class I) or contaminated cases (CDC class II-IV). The pooled proportion of surgical site infection (SSI), surgical site occurrence (SSO), hernia recurrence, total surgical complications, and reoperation were calculated in 391 clean and 81 contaminated cases. For clean vs. contaminated cases, the following pooled proportions were noted: SSI (2% (CI 0-7%) vs 9% (CI 0-025) (p = 0.03), SSO: 14% (CI 5-25%) vs 35% (CI 22-50%) (p = 0.006), hernia recurrence (8% (CI 1-19%) vs 4% (CI 0-12%) (p = 0.769); surgical complications (17% (CI 6-32%) vs 50% (CI 27-72%) (p = 0.009). Reoperation data were available in 298 clean cases across four studies: 5% (CI 0-15%). CONCLUSIONS: P4HB biosynthetic mesh may be more effective than previously thought, particularly in clean wounds. P4HB may also be superior to biologic mesh when compared to clinical trial data. Further research is necessary for more direct comparison.

Rituximab as a single agent in the management of adult patients with haemophilia A and inhibitors: marked reduction in inhibitor level and clinical improvement in bleeding but failure to eradicate the inhibitor.

Management of patients with severe haemophilia A who develop inhibitors is difficult and expensive. Standard treatment of this complication is immune tolerance induction (ITI) therapy, but is successful in only 60-80% of the patients. Failure of ITI results in a higher risk of morbidity and mortality. We used rituximab, an anti-CD20 antibody, in three patients with severe haemophilia A and inhibitors. Two patients with high-titre inhibitors had marked reduction in the inhibitor level; the third patient with low-titre inhibitor had a disappearance of the inhibitor. All patients improved clinically, with fewer bleeding episodes and a better quality of life. Inhibitor level increased with time in these patients, but the clinical benefit continued in two patients with high-titre inhibitors initially, after a follow-up of 48 and 22 months. One of the patients with concomitant human immunodeficiency virus (HIV) infection and a very low CD4 lymphocyte count developed severe truncal herpes zoster after the third weekly dose of rituximab. Caution is required in such patients, and we recommend avoiding rituximab use in HIV-infected patients with very low CD4 lymphocyte count. In conclusion, rituximab is useful in reducing the inhibitor level with clinical benefit in patients with severe haemophilia A and inhibitors, but it cannot eradicate the inhibitors for long periods with the currently used protocol of up to five doses.

Phase I study of liposomal vincristine.

PURPOSE: A phase I study of vincristine encapsulated inside 120-nm-diameter distearoylphosphatidylcholine-cholesterol liposomes was performed. The primary objectives were to determine the maximum-tolerated dose (MTD), recommended phase II dose, toxicity, and pharmacokinetics of liposomal vincristine (ONCO-TCS). PATIENTS AND METHODS: Twenty-five patients with histologically confirmed malignancies were enrolled and assessable. Vincristine doses were increased from 0.5 mg/m2 to 1.0, 1.5, 2.0, 2.4, and 2.8 mg/m2 with cohorts of three or more patients per dose level. A total of 64 courses of ONCO-TCS were administered intravenously once every 3 weeks. The pharmacokinetics of total vincristine content in plasma were determined using a high-performance liquid chromatography method. RESULTS: Patients were treated with vincristine doses up to 2.8 mg/m2; however, 2.4 mg/m2 was defined as the MTD and 2.0 mg/m2 as the phase II recommended dose. Pain and obstipation were the dose-limiting toxicites. Other toxicities were fever, rigors, fatigue, myalgias, and peripheral neuropathy. Hematologic toxicity was mild. All patients who were treated with doses above 1.5 mg/m2 received in excess of 2.0 mg of vincristine, with doses as high as 6.2 mg. One partial response was seen in a patient with pancreatic cancer. Tumor response not meeting partial response criteria was seen in two other patients. Pharmacokinetic studies revealed significantly elevated concentrations of total vincristine, but parameters varied and were not directly correlated with toxicity or response. CONCLUSION: The ability to administer elevated doses of vincristine, as well as indications of efficacy, suggests that ONCO-TCS warrants further clinical investigation in a phase II setting.

Primary synovial sarcoma of the penis--case report and literature review.

Urogenital synovial sarcoma is an exceedingly rare lesion that can be clinically confused with chronic inflammatory masses and granulomas, squamous cell carcinoma, malignant melanoma or metastatic tumours. We present a case of primary synovial sarcoma of the penis in a 29-year-old Egyptian male. This case report is, to the best of our knowledge, the first report in the medical literature. A review of other penile sarcomas is included with a description and discussion of their pathological and clinical manifestations.