Women's Reasons to Seek Bariatric Surgery and Their Expectations on the Surgery Outcome - a Multicenter Study from Five European Countries.

PURPOSE: Understanding patients' reasons for having bariatric surgery and their expectation on surgery outcomes is important to provide the best clinical practice and reduce unrealistic expectations. It is unknown if reasons and expectations differ between countries. We aimed to investigate the reasons for seeking bariatric surgery and expectations of surgical outcomes among patients in five European countries. METHODS: In total, 250 women accepted for bariatric surgery were recruited: 50 women each from Finland, Germany, Norway, Sweden, and the Netherlands. Participants ranked 14 reasons for seeking surgery, and reported the three primary reasons. They also reported expectations on weight loss and impact of surgery vs. lifestyle on weight loss outcomes. RESULTS: Mean age and body mass index were 42.9 ± 11.5 years and 45.1 ± 6.2 kg/m2, respectively. Weight loss and improved co-morbidity were ranked as the most important reasons. Participants expected to lose between 70.8 and 94.3% of their excessive weight. The expected impact of surgery as a driver of weight loss was higher in Germany and the Netherlands compared to in Finland, Norway, and Sweden where participants expected lifestyle changes to also have an impact. CONCLUSION: Weight loss and improved co-morbidities were the main reasons for undergoing bariatric surgery. Expectations on weight loss were generally very high, but expectations of surgery vs. lifestyle as the main driver of weight loss differed between countries. While some patients understand the importance of lifestyle change and maintenance of a healthy lifestyle after surgery in order to obtain a successful weight loss, other may need additional counselling.

Semi-nested RT-PCR enables sensitive and high-throughput detection of SARS-CoV-2 based on melting analysis.

BACKGROUND: Asymptomatic transmission was found to be the Achilles' heel of the symptom-based screening strategy, necessitating the implementation of mass testing to efficiently contain the transmission of COVID-19 pandemic. However, the global shortage of molecular reagents and the low throughput of available realtime PCR facilities were major limiting factors. METHODS: A novel semi-nested and heptaplex (7-plex) RT-PCR assay with melting analysis for detection of SARS-CoV-2 RNA has been established for either individual testing or 96-sample pooled testing. The complex melting spectrum collected from the heptaplex RT-PCR amplicons was interpreted with the support of an artificial intelligence algorithm for the detection of SARS-CoV-2 RNA. The analytical and clinical performance of the semi-nested RT-PCR assay was evaluated using RNAs synthesized in-vitro and those isolated from nasopharyngeal samples. RESULTS: The LOD of the assay for individual testing was estimated to be 7.2 copies/reaction. Clinical performance evaluation indicated a sensitivity of 100% (95% CI: 97.83-100) and a specificity of 99.87% (95% CI: 99.55-99.98). More importantly, the assay supports a breakthrough sample pooling method, which makes possible parallel screening of up to 96 samples in one real-time PCR well without loss of sensitivity. As a result, up to 8,820 individual pre-amplified samples could be screened for SARS-CoV-2 within each 96-well plate of realtime PCR using the pooled testing procedure. CONCLUSION: The novel semi-nested RT-PCR assay provides a solution for highly multiplex (7-plex) detection of SARS-CoV-2 and enables 96-sample pooled detection for increase of testing capacity. .

Use of machine learning in prediction of granule particle size distribution and tablet tensile strength in commercial pharmaceutical manufacturing.

In the manufacturing of pharmaceutical Oral Solid Dosage (OSD) forms, Particle Size Distribution (PSD) and Tensile Strength (TS) are common in-process tests that are controlled in order to achieve the quality targets of the end-product. The Quality by Design (QbD) concept elaborates process understanding and sufficient controls. However, for older pharmaceutical products upscaled to commercial phase with Quality by Testing (QbT) approach, the knowhow of the product-specific critical parameters is often limited. In this study, two predictive machine learning (ML) models were used for a commercial tablet product, for which historical data of raw materials, production, in-process controls and condition monitoring were available. With the aforementioned data, the aim was to predict the PSD and the TS that indicate the product quality. The feature importance was used to evaluate the parameter importance for the PSD and the TS. Partial dependence, in turn, was used to estimate the parameter impact on the predicted TS. The study illustrates the capability of the ML models to bring additional value for commercial products through the enhanced product-related knowhow.

Effect of operating air pressure on tribochemical silica-coating.

OBJECTIVE: Alumina and zirconia are inert to conventional etching and need to be initially conditioned with, for example, silicatization. The aim of the present study was to evaluate the effect of operating air pressure of tribochemical silica-coating method on the shear bond strength of composite resin to ceramic substrates. MATERIAL AND METHODS: Alumina (Procera Alumina, Nobel Biocare) and zirconia (LAVA; 3M ESPE and Procera Zirconia; Nobel Biocare) were airborne particle silica-coated (CoJet; 3M ESPE) using selected, clinically available air pressures of 150, 220, 300, and 450 kPa. The surfaces were silanized with silane coupling agent (ESPE Sil; 3M ESPE) and coated with adhesive resin (3M Multipurpose resin; 3M ESPE). Particulate filler resin composite (Z250; 3M ESPE) stubs (diameter 3.6 mm, height 4.0 mm) were added onto ceramics and light-cured for 40 s. The test specimens (n=18/group) were thermocycled (6000 x 5-55 degrees C) and shear bond strengths were measured with a cross-head speed of 1.0 mm/min. Fracture surfaces were examined with SEM, and an elemental analysis (EDS) was carried out to determine silica content on the substrate surface. RESULTS: The highest bond strengths were obtained with the highest pressures. ANOVA showed significant differences in bond strength between the ceramics (p<0.05) and between the specimens treated at various air pressures (p<0.05). CONCLUSIONS: Clinically, the operating air pressure of silicatization may have a significant effect on bond strength to non-etchable ceramics.

Evaluation of resin adhesion to zirconia ceramic using some organosilanes.

OBJECTIVES: This study evaluated and compared the effect of three trialkoxysilane coupling agents on the bond strength of a Bis-GMA-based unfilled resin and a dimethacrylate-based resin composite luting cement to a zirconia ceramics (Procera AllZircon, Nobel Biocare, Göteborg, Sweden). METHODS: Six square-shaped zirconia specimens were used for each test group, a total of 72 specimens. The specimens in each group were all assigned to air-borne alumina particle abrasion followed by tribochemical silica-coating and silanization with 1 vol% solutions of 3-methacryloyloxypropyltrimethoxysilane, 3-acryloyloxypropyltrimethoxysilane, or 3-isocyanatopropyltriethoxysilane in an ethanol-water mixture. The sample stubs were made of a Bis-GMA/MMA/DMAEMA resin or a commercial resin composite luting cement (RelyX ARC, 3M ESPE, Seefeld, Germany). They were bonded to the conditioned and silanized silica-coated zirconia specimens using polyethylene molds. All specimens were tested at dry and thermo-cycled (6000, 5-55 degrees C, 30 s) conditions. The shear bond strength of resin stubs to zirconia was measured in a universal testing machine (cross-head speed 1 mm/min). RESULTS: In dry conditions, the highest shear bond strength was 9.7 MPa (S.D. 3.3 MPa), and for thermo-cycled samples 7.4 MPa (S.D. 2.4 MPa) was obtained with RelyX ARC cement with 3-methacryloyloxypropyltrimethoxysilane. In general, thermo-cycling decreased the bond strengths significantly for the Bis-GMA resin (ANOVA, p < 0.005). The resin, cement and silanes differed significantly silanes (ANOVA, p < 0.005). All samples silanized with 3-isocyanatopropyltriethoxysilane de-bonded during thermo-cycling. De-bonding was dominantly due to adhesive failure. SIGNIFICANCE: Bonding of the experimental resin and commercial cement to silica-coated zirconia is effective with 3-methacryloyloxypropyltrimethoxysilane or 3-methacryloyloxypropyltrimethoxysilane, but not with 3-isocyanatopropyltriethoxysilane.

Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study.

We evaluated the 3-year outcome of a series of patients with primary varicose veins who were randomized to radiofrequency endovenous obliteration vs. stripping of the long saphenous vein (LSV). Twenty-eight patients were included in the study: 15 were randomized to the radiofrequency endovenous obliteration procedure and 13 to LSV stripping. At 3-year follow-up, five patients (33.3%) of the endovenous group had recurrent or residual varices and in three of them a reflux in the thigh veins was detected. None of the primarily occluded LSV segments was recanalized. In the stripping group, three patients (23.1%, p = 0.68) showed varicosities at clinical and duplex examinations. In one patient, a patent duplicate LSV trunk was detected. In the remaining two patients, no reflux in the thigh region was detected. According to the present results, radiofrequency endovenous obliteration of the LSV is associated with somewhat poorer short-term results compared with the stripping operation.

Early results of a single-blinded, randomized, controlled, Internet-based multicenter trial comparing Prolene and Vypro II mesh in Lichtenstein hernioplasty.

BACKGROUND: The standard polypropylene mesh used in Lichtenstein's operation induces a strong foreign-tissue reaction with potentially harmful effects. A mesh with less polypropylene could possibly be beneficial. PATIENTS AND METHODS: Six hundred men with inguinal hernias were randomized to Lichtenstein's operation with Prolene or Vypro II in a single-blinded multicenter trial. The randomization was performed by a computer algorithm in a database through the Internet. All data were entered and directly validated in the database through the Internet. RESULTS: The meshes had comparable results in return to work, return to daily activities, complications, postoperative pain, and quality of life during the first 8 weeks of rehabilitation. CONCLUSIONS: Lichtenstein's operation with either Prolene or Vypro II is safe and well tolerated with an acceptable postoperative rehabilitation time and a high quality of life 2 months after surgery. The study was facilitated by the use of a database through the Internet.

Tension-free inguinal hernia repair: TEP versus mesh-plug versus Lichtenstein: a prospective randomized controlled trial.

OBJECTIVE: To compare laparoscopic hernioplasty with two open tension-free hernia repairs. SUMMARY BACKGROUND DATA: Laparoscopic hernioplasty is associated with a short rehabilitation, but it is a technically difficult procedure. It is unclear if it has advantages over the technically easier open tension-free herniorrhaphy. METHODS: Two hundred ninety-nine men 30 to 75 years old were randomized to undergo laparoscopic totally extraperitoneal hernioplasty (TEP), open operation with mesh-plug and patch, or Lichtenstein's operation. RESULTS: Two hundred ninety-four (98%) patients were followed for 19.8 +/- 8.6 months. Over 90% of the patients in all groups were operated in day surgery; the rest of the patients were all discharged within 24 hours. Postoperative pain (visual analog score) was lower in the patients undergoing TEP than in those undergoing Lichtenstein and mesh-plug procedures. The median sick-leave period was 5 days in the TEP group, 7 days in the mesh-plug group, and 7 days in the Lichtenstein group. The median time to full recovery was significantly shorter in the TEP group compared to the other two groups. There were no major complications. Two recurrences were found in the TEP group and two in the mesh-plug group. CONCLUSIONS: Laparoscopic hernioplasty is superior to tension-free open herniorrhaphy in terms of postoperative pain and rehabilitation.

Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs.

OBJECTIVE: The aim of this randomized study was to compare a new method of endovenous saphenous vein obliteration (Closure System, VNUS Medical Technologies, Inc, Sunnyvale, Calif) with the conventional stripping operation in terms of short-term recovery and costs. METHODS: Twenty-eight selected patients for operative treatment of primary greater saphenous vein tributary varicose veins were randomly assigned to endovenous obliteration (n = 15) or stripping operation (n = 13). Postoperative pain was daily assessed during the 1st week and on the 14th postoperative day. The length of sick leave was determined. The RAND-36 health survey was used to assess the patient health-related quality of life. The patient conditions were controlled 7 to 8 weeks after surgery, and patients underwent examination with duplex ultrasonography. The comparison of costs included both direct medical costs and costs resulting from lost of productivity of the patients. Costs that were similar in the study groups were not considered in the analysis. RESULTS: All operations were successful, and the complication rates were similar in the two groups. Postoperative average pain was significantly less severe in the endovenous obliteration group as compared with the stripping group (at rest: 0.7, standard deviation [SD] 0.5, versus 1.7, SD 1.3, P =.017; on standing: 1.3, SD 0.7, versus 2.6, SD 1.9, P =.026; on walking: 1.8, SD 0.8, versus 3.0, SD 1.8, P =.036; with t test). The sick leaves were significantly shorter in the endovenous obliteration group (6.5 days, SD 3.3 days, versus 15.6 days, SD 6.0 days; 95% CI, 5.4 to 12.9; P <.001, with t test). Physical function was also restored faster in the endovenous obliteration group. The estimated annual investment costs of the closure operation were US $3360. The other direct medical costs of the Closure operation were about $850, and those of the conventional treatment were $360. With inclusion of the value of the lost working days, the Closure treatment was cost-saving for society, and when 40% of the patients are retired (or 60% of the productivity loss was included), the Closure procedure became cost-saving at a level of 43 operations per year. CONCLUSION: Endovenous obliteration may offer advantages over the conventional stripping operation in terms of reduced postoperative pain, shorter sick leaves, and faster return to normal activities, and it appears to be cost-saving for society, especially among employed patients. Because the procedure is also associated with shorter convalescence, this new method may potentially replace conventional varicose vein surgery.