Additional surgical procedure is a risk factor for surgical site infections after laparoscopic cholecystectomy

PURPOSE: Surgical site infections (SSI) are associated with increased costs and length of hospital stay, readmission rates, and mortality. The aim of this study was to identify risk factors for SSI in patients undergoing laparoscopic cholecystectomy. METHODS: Analysis of 35,432 laparoscopic cholecystectomies of a prospective multicenter database was performed. Risk factors for SSI were identified among demographic data, preoperative patients' history, and operative data using multivariate analysis. RESULTS: SSIs after laparoscopic cholecystectomy were seen in 0.8 % (n = 291) of the patients. Multivariate analysis identified the following parameters as risk factors for SSI: additional surgical procedure (odds ratio [OR] 4.0, 95 % confidence interval [CI] 2.2-7.5), age over 55 years (OR 2.4 [1.8-3.2]), conversion to open procedure (OR 2.6 [1.9-3.6]), postoperative hematoma (OR 1.9 [1.2-3.1]), duration of operation >60 min (OR 2.5 [1.7-3.6], cystic stump insufficiency (OR 12.5 [4.2-37.2]), gallbladder perforation (OR 6.2 [2.4-16.1]), gallbladder empyema (OR 1.7 [1.1-2.7]), and surgical revision (OR 15.7 [10.4-23.7]. SSIs were associated with a significantly prolonged hospital stay (p < 0.001), higher postoperative mortality (p < 0.001), and increased rate of surgical revision (p < 0.001). CONCLUSIONS: Additional surgical procedure was identified as a strong risk factor for SSI after laparoscopic cholecystectomy. Furthermore, operation time >60 min, age >55 years, conversion to open procedure, cystic stump insufficiency, postoperative hematoma, gallbladder perforation, gallbladder empyema, or surgical revision were identified as specific risk factors for SSI after laparoscopic cholecystectomy.

The Self-Expanding Symetis Acurate Does Not Increase Cerebral Microembolic Load When Compared to the Balloon-Expandable Edwards Sapien Prosthesis: A Transcranial Doppler Study in Patients Undergoing Transapical Aortic Valve Implantation

Objectives The aim of this study was to quantify potential differences in count, frequency and pattern of high-intensity transient signals (HITS) during transapical transcatheter aortic valve implantation (TA-TAVI), by comparing the Symetis Acurate TA (SA) with the balloon-expandable Edwards Sapien XT (ES) system. Background Recently, the Symetis Acurate TA revalving system has been introduced for TA-TAVI. The Symetis Acurate TA aortic bioprosthesis is self-expanding and is deployed by a specific two-step implantation technique. Whether this novel method increases the load of intraprocedural emboli, detected by transcranial Doppler ultrasound (TCD) as HITS, or not is not clear. Methods Twenty-two patients (n = 11 in each study arm, median logistic EuroScore 20%, median STS score 7%) displayed continuous TCD signals of good quality throughout the entire TA-TAVI procedure and were included in the final analysis. Data are presented as median with interquartile ranges. Results No significant differences were detected in total procedural or interval-related HITS load (SA: 303 [200; 594], ES: 499 [285; 941]; p = 0.16). With both devices, HITS peaked during prosthesis deployment (PD), whereas significantly fewer HITS occurred during instrumentation (SA: p = 0.002; ES: <0.001) or post-implantation PI (SA: p = 0.007; ES: <0.001). PD-associated HITS amounted to almost half of the total HITS load. One patient suffered new disabling stroke at 30 days. Thirty-day mortality amounted to 13.6% (3 of 22 patients). Conclusions Simplified transapical delivery using the self-expanding SA device does not increase HITS, despite of a two-step deployment technique with more interactions with the native aortic valve, when compared to the balloon-expandable ES valve. The similarity in HITS count, frequency and pattern with the two systems suggests a common mechanism for the release of cerebral microemboli.

Making regression tables simplified

estout, introduced by Jann (Stata Journal 5: 288–308), is a useful tool for producing regression tables from stored estimates. However, its syntax is relatively complex and commands may turn out long even for simple tables. Furthermore, having to store the estimates beforehand can be cumbersome. To facilitate the production of regression tables, I therefore present here two new commands called eststo and esttab. eststo is a wrapper for offcial Stata’s estimates store and simplifies the storing of estimation results for tabulation. esttab, on the other hand, is a wrapper for estout and simplifies compiling nice-looking tables from the stored estimates without much typing. I also provide updates to estout and estadd.

AIV procedure for a CHEOPS demonstration model

The CHaracterizing ExOPlanet Satellite (CHEOPS) is an ESA Small Mission whose launch is planned for the end of 2017. It is a Ritchey-Chretien telescope with a 320 mm aperture providing a FoV of 0.32 degrees, which will target nearby bright stars already known to host planets, and measure, through ultrahigh precision photometry, the radius of exo-planets, allowing to determine their composition. This paper will present the details of the AIV plan for a demonstration model of the CHEOPS Telescope with equivalent structure but different CTEs. Alignment procedures, needed GSEs and devised verification tests will be described and a path for the AIV of the flight model, which will take place at industries premises, will be sketched. © (2014) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE).

Procedure for short-lived particle detection in the OPERA experiment and its application to charm decays

The OPERA experiment, designed to perform the first observation of νμ→ντ oscillations in appearance mode through the detection of the τ leptons produced in ντ charged current interactions, has collected data from 2008 to 2012. In the present paper, the procedure developed to detect τ particle decays, occurring over distances of the order of 1 mm from the neutrino interaction point, is described in detail. The results of its application to the search for charmed hadrons are then presented as a validation of the methods for ντ appearance detection.

Is hysterectomy nowadays an obsolete procedure?

After the general morbidity reduction at the beginning of the century and the routine use of prophylactic antibiotics, a hysterectomy was generously, sometimes to generously indicated in the middle of the 20th century. This might be one of the major reasons why the procedure got a bad reputation. Furthermore, in the last decade, several new treatments for benign uterine pathologies have been developed which can be proposed to the patients instead of performing a hysterectomy. Therefore, the question might be asked, if nowadays there are still some indications for a hysterectomy or if the procedure is obsolete.

A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial

BACKGROUND/AIMS Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc). METHODS This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial's sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure. RESULTS We included 142 of 231 protocols in the final analysis (concept = 78; ad hoc = 64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval = 0.10-0.58)) than in the concept arm (0.27 (0.06-0.50)), but the difference was not significant (p = 0.67). LIMITATIONS The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law. CONCLUSION A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines, examples and templates to ensure correct application.

Temperature Prediction Model for Bone Drilling Based on Density Distribution and In Vivo Experiments for Minimally Invasive Robotic Cochlear Implantation

Surgical robots have been proposed ex vivo to drill precise holes in the temporal bone for minimally invasive cochlear implantation. The main risk of the procedure is damage of the facial nerve due to mechanical interaction or due to temperature elevation during the drilling process. To evaluate the thermal risk of the drilling process, a simplified model is proposed which aims to enable an assessment of risk posed to the facial nerve for a given set of constant process parameters for different mastoid bone densities. The model uses the bone density distribution along the drilling trajectory in the mastoid bone to calculate a time dependent heat production function at the tip of the drill bit. Using a time dependent moving point source Green's function, the heat equation can be solved at a certain point in space so that the resulting temperatures can be calculated over time. The model was calibrated and initially verified with in vivo temperature data. The data was collected in minimally invasive robotic drilling of 12 holes in four different sheep. The sheep were anesthetized and the temperature elevations were measured with a thermocouple which was inserted in a previously drilled hole next to the planned drilling trajectory. Bone density distributions were extracted from pre-operative CT data by averaging Hounsfield values over the drill bit diameter. Post-operative [Formula: see text]CT data was used to verify the drilling accuracy of the trajectories. The comparison of measured and calculated temperatures shows a very good match for both heating and cooling phases. The average prediction error of the maximum temperature was less than 0.7 °C and the average root mean square error was approximately 0.5 °C. To analyze potential thermal damage, the model was used to calculate temperature profiles and cumulative equivalent minutes at 43 °C at a minimal distance to the facial nerve. For the selected drilling parameters, temperature elevation profiles and cumulative equivalent minutes suggest that thermal elevation of this minimally invasive cochlear implantation surgery may pose a risk to the facial nerve, especially in sclerotic or high density mastoid bones. Optimized drilling parameters need to be evaluated and the model could be used for future risk evaluation.

[Pilot Project: Improved Lung Deposition via a New Nasal Inhalation Procedure].

INTRODUCTION Inhaled drugs can only be effective if they reach the middle and small airways. This study introduces a system that combines a trans-nasal application of aerosols with noninvasive pressure support ventilation. METHODS In a pilot study, 7 COPD patients with GOLD stages II and III inhaled a radiolabeled marker dissolved in water via a trans-nasal route. The mean aerosol particle size was 5.5 µm. Each patient took part in two inhalation sessions that included two application methods and were at least 70 hours apart. During the first session ("passive method"), the patient inhaled the aerosol through an open tube system. The second session ("active method") included pressure support ventilation during the inhalation process. A gamma camera and planar scintigraphy was used to determine the distribution of aerosol particles in the patient's body and lung. RESULTS The pressure supported inhalation ("active method") results in an increased aerosol lung deposition compared to the passive method. Above all, we could demonstrate deposition in the lung periphery with relatively large aerosol particles (5.5 µm). DISCUSSION The results prove that the combination of trans-nasal inhalation with noninvasive pressure support ventilation leads to significantly increased particle deposition in the lung.