Medium-term safety and efficacy profile of paraesophageal hernia repair with Phasix-ST® mesh: a single-institution experience.

BACKGROUND: Hernia recurrence after laparoscopic repair is a perplexing problem. In an effort to reduce anatomical and clinical recurrences, different type of meshes have been used to bolster the esophageal hiatus. OBJECTIVE: The aim of this study was to assess safety, medium-term efficacy, and quality of life improvement after laparoscopic repair of hiatal hernia reinforced with a biosynthetic absorbable mesh (Phasix-ST®). METHODS: Observational single-center retrospective single-arm cohort study (November 2015-February 2021). We included all adult patients (> 18 years old) who underwent laparoscopic paraesophageal hernia repair with Phasix-ST® mesh and Toupet fundoplication. RESULTS: Sixty-eight patients were included. The median postoperative stay was 3.2 days (range 2-9) and the postoperative complication rate was 11.7%. The median follow-up time was 27 months (range 1-53). No mesh-related complications were detected. Hernia recurrence was diagnosed in six patients (8.8%). The recurrence-free probability at 34 months was 0.89 (95% CI 0.807-0.988) while at 60 months was 0.86 (95% CI 0.76-0.97). Hernia recurrences were mostly observed between 21 and 36 months after the operation. None of the patients required surgical revision and all were managed with PPI. Postoperative dysphagia requiring endoscopic balloon dilatation occurred in 2.9% of patients. Compared to baseline, both the GERD-HRQL (15.2 ± 6.2 vs. 3.2 ± 3.1; p = 0.026) and all SF-36 items were significantly improved (p < 0.001). CONCLUSIONS: Laparoscopic crura augmentation with Phasix-ST® mesh combined with a Toupet fundoplication is safe and seems effective in the medium-term follow-up. Phasix-ST® crural reinforcement resulted in low hernia recurrence rate with a sustained symptoms and quality of life improvement.

Micro- and macro-viscosity relations in high concentration antibody solutions.

Molecular crowding in highly concentrated monoclonal antibody (mAb) solutions results in significant increases in viscosity, which complicates fill-finish steps and patient administration by subcutaneous injection. As viscosity measurements for optimization of the mAb formulation require significant amounts of material not always available in early development, fluorescence correlation spectroscopy (FCS) is evaluated as a potential ultra-low volume technique for viscosity measurement of high concentration protein solutions assuming the Generalised Stokes Einstein relation (GSE) remains valid. Using like-charge fluorescent tracers of different sizes, FCS provided measurements of microviscosities which were compared to the macroviscosity. After parametrising the protein concentration dependence of the viscosity by the exponential coefficient (k) of a simple exponential model, FCS derived k-values of like-size tracer to the crowder followed the same ordering as the macroviscosity derived k-values with respect to solvent conditions. Furthermore, k and the diffusion-derived protein-protein interaction parameter, kD, are linked, and, attractive conditions for mAbs result in a stronger concentration dependence of the viscosity. For tracers and crowders of like-size, a key result is negative deviations from the GSE relation are observed in presence of strong attractive interactions between crowder molecules. These data demonstrate that FCS has application to the screening of high concentration mAb solutions for formulation selection.

Impact of the Italian Society of Anatomic Pathology and Diagnostic Cytology Classification of Thyroid Nodules in the Treatment of Indeterminate Follicular Lesions: Five-Year Results at a Single Center.

PURPOSE: Aim of the study was to assess the impact of the Italian Society of Anatomic Pathology and Diagnostic Cytology (SIAPEC) classification of 2014, on the treatment of indeterminate thyroid lesions (TIR3). METHODS: We retrospectively analyzed patients undergoing thyroid surgery for TIR3 lesions between 2013 and 2018, at the General Surgery Department of Trieste University Hospital. According to the SIAPEC classification, patients were divided into TIR3A and TIR3B groups. All patients treated before 2014 underwent surgical treatment, and surgical specimens were retrospectively classified after revision of fine-needle aspiration cytology. Starting 2014, TIR3A patients were treated only when symptomatic (i.e., coexistent bilateral thyroid goiter or growing TIR3A nodules), whereas TIR3B patients always received surgical treatment. Hemithyroidectomy (HT) was the procedure of choice. Total thyroidectomy (TT) was performed in case of concurrent bilateral goiter, autoimmune thyroid disease, and/or presence of BRAF and/or RAS mutation. Lastly, we analyzed the malignancy rate in the two groups. RESULTS: 29 TIR3A and 90 TIR3B patients were included in the study. HT was performed in 10 TIR3A patients and 37 TIR3B patients, respectively, with need for reoperation in 4 TIR3B (10.8%) patients due to histological findings of follicular thyroid carcinoma >1 cm. The malignancy rates were 17.2% in TIR3A and 31.1% in TIR3B, (p = 0.16). Predictability of malignancy was almost 89% in BRAF mutation and just 47% in RAS mutation. CONCLUSIONS: The new SIAPEC classification in association with biomolecular markers has improved diagnostic accuracy, patient selection, and clinical management of TIR3 lesions.