Background
Under the mandate of the European Association for Endoscopic Surgery (EAES) a guideline on methodology of innovation management in endoscopic surgery has been developed. The primary focus ...of this guideline is patient safety, efficacy, and effectiveness.
Methods
An international expert panel was invited to develop recommendations for the assessment and introduction of surgical innovations. A consensus development conference (CDC) took place in May 2009 using the method of a nominal group process (NGP). The recommendations were presented at the annual EAES congress in Prague, Czech Republic, on June 18th, 2009 for discussion and further input. After further Delphi processes between the experts, the final recommendations were agreed upon.
Results
The development and implementation of innovations in surgery are addressed in five sections: (1) definition of an innovation, (2) preclinical and (3) clinical scientific development, (4) scientific approval, and (5) implementation along with monitoring. Within the present guideline each of the sections and several steps are defined, and several recommendations based on available evidence have been agreed within each category. A comprehensive workflow of the different steps is given in an algorithm. In addition, issues of health technology assessment (HTA) serving to estimate efficiency followed by ethical directives are given.
Conclusions
Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.
Bile leaks are serious complications after laparoscopic cholecystectomy. The aim of this study was to evaluate the feasibility of closure of the cystic duct with a new feedback-controlled bipolar ...sealing system (LigaSure).
Ten domestic pigs underwent open cholecystectomy with the cystic duct and artery dissected and sealed with the new bipolar sealing system (LigaSure). Four and 8 days postoperatively, 5 pigs each were sacrificed and the closure of the cystic duct was evaluated. The cystic stump and the common bile duct were excised for histological examination.
None of the pigs had a bile leak or a biliary peritonitis. There were no signs of postoperative bleeding or inflammation in Calot's triangle. Histology showed total necrosis of the cystic duct in the first two pigs due to too much energy used. The remaining specimens showed a regularly scaling zone without necrosis in 7 cases, and in one case a partial necrosis in the mucosa only was found.
Cystic artery and cystic duct closure with the new device may be an alternative to the clip. Further trials should evaluate the feasibility and safety of the new device in the clinical setting.
An increasing number of modern imaging procedures are being applied for the diagnosis of appendicitis. We compared one hundred consecutive appendectomies of the years 1988, 1998 and 2008 concerning ...reliability of preoperative diagnosis and resulting costs.
We analysed the first one hundred consecutive patients undergoing appendectomy during the years 1988, 1998 and 2008, 59 % were female and 41 % male. The average age was 26 years, the average BMI 21.09. The costs and results of radiological investigations (US, CT, MRI, X-ray) have been compared in all patients. The sensitivity of ultrasound and CT scan in preoperative diagnosis has been analysed.
The number of preoperative imaging procedures for the diagnosis of appendicitis has increased over the last two decades. Simultaneously increased the costs (total costs and costs per partient) for imaging procedures. 2008 the costs were 10 times higher than 1988. CT had a higher sensitivity (77 %) in the diagnosis of appendicitis than ultrasound (33 %). The number of operations because of subacute and chronic appendicitis was lower in 2008 (34 of 100) compared with 1988 (80 of 100) and 1998 (60 of 100). In 2008 (14) we found a higher number of gangrenous and perforated appendicitis compared to 1988 (2) and 1998 (5). The majority (50 of 100) of patients in the group with acute and phlegmonous appendicitis was found in 2008.
There has been an increase in the use of preoperative imaging procedures in the diagnosis of appendicitis during the last 20 years. This causes more costs in the public health system. Ultrasound as the standard imaging method for diagnosing appendicitis showed poor sensitivity. CT scans had good results concerning sensitivity, but are expensive and involve exposure to radiation for the patient.
In four experiments, we demonstrated a new phenomenon called “slow-change deafness.” In Experiment
1
we presented listeners with continuous speech that changed three semitones in pitch over time, and ...we found that nearly 50 % failed to notice the change. Experiments
2
and
3
replicated the finding, demonstrated that the changes in the stimuli were well above threshold, and showed that when listeners were alerted to the possibility of a change, detection rates improved dramatically. Experiment
4
showed that increasing the magnitude of the change that occurred in the stimulus decreased the rate of change deafness. Our results are consistent with previous work that had shown that cueing listeners to potential auditory changes can significantly reduce change deafness. These findings support an account of change deafness that is dependent on both the magnitude of a stimulus change and listener expectations.
A study of the associated production of a $\mathrm{Z} $ boson and a charm quark jet ( $\mathrm{Z} + \mathrm{c} $ ), and a comparison to production with a $\mathrm{b} $ quark jet ( $\mathrm{Z} + ...\mathrm{b} $ ), in $\mathrm {p}\mathrm {p}$ collisions at a centre-of-mass energy of 8 $\,\text {TeV}$ are presented. The analysis uses a data sample corresponding to an integrated luminosity of 19.7 $\,\text {fb}^{-1}$ , collected with the CMS detector at the CERN LHC. The $\mathrm{Z} $ boson candidates are identified through their decays into pairs of electrons or muons. Jets originating from heavy flavour quarks are identified using semileptonic decays of $\mathrm{c} $ or $\mathrm{b} $ flavoured hadrons and hadronic decays of charm hadrons. The measurements are performed in the kinematic region with two leptons with $p_{\mathrm {T}} ^{\ell } > 20\,\text {GeV} $ , ${|\eta ^{\ell }|} < 2.1$ , $71< m_{\ell \ell } < 111\,\text {GeV} $ , and heavy flavour jets with $p_{\mathrm {T}} ^{\text {jet}} > 25\,\text {GeV} $ and ${|\eta ^{ \text {jet}}|} < 2.5$ . The $\mathrm{Z} + \mathrm{c} $ production cross section is measured to be $\sigma (\mathrm {p}\mathrm {p}\rightarrow \mathrm{Z} + \mathrm{c} + X) \mathcal {B}(\mathrm{Z} \rightarrow \ell ^+\ell ^-) = 8.8 \pm 0.5\,\text {(stat)} \pm 0.6\,\text {(syst)} \,\text {pb} $ . The ratio of the $\mathrm{Z} + \mathrm{c} $ and $\mathrm{Z} + \mathrm{b} $ production cross sections is measured to be $\sigma (\mathrm {p}\mathrm {p}\rightarrow \mathrm{Z} + \mathrm{c} + X)/\sigma (\mathrm {p}\mathrm {p}\rightarrow \mathrm{Z} + \mathrm{b} + X) = 2.0 \pm 0.2\,\text {(stat)} \pm 0.2\,\text {(syst)} $ . The $\mathrm{Z} + \mathrm{c} $ production cross section and the cross section ratio are also measured as a function of the transverse momentum of the $\mathrm{Z} $ boson and of the heavy flavour jet. The measurements are compared with theoretical predictions.
To examine the feasibility of a new, minimally invasive procedure for the devascularization of the proximal stomach and distal esophagus to prevent recurrent variceal bleeding in portal hypertension ...in a new animal model.
Portal hypertension was created by laparoscopic clip ligation of the portal vein on 20 pigs. After 2 weeks the azygoportal disconnection procedure was performed with the LigaSure-ATLAS instrument.
There were 16 pigs out of 20 that survived both operations. Two died during introduction of anesthesia, one because of a cardiac arrest (second operation). One pig died resulting from necrosis of the gastric and esophageal wall. Autopsy (2 weeks later) showed that there was a complete arterial devascularization. At autopsy, none of the remaining 16 pigs had esophageal varices or necrosis of the stomach or esophagus.
Laparoscopic azygoportal disconnection is a less invasive method for the prevention of rebleeding and seems to be safely performed with the LigaSure-ATLAS instrument.
The production of jets in association with Z bosons, reconstructed via the mu+mu- and e+e- decay channels, is studied in pp and, for the first time, in PbPb collisions. Both data samples were ...collected by the CMS experiment at the LHC, at a center-of-mass energy of 5.02 TeV. The PbPb collisions were analyzed in the 0-30% centrality range. The back-to-back azimuthal alignment was studied in both pp and PbPb collisions for Z bosons with transverse momentum ptz > 60 GeV/c and a recoiling jet with ptj > 30 GeV/c. The pt imbalance, xjz= ptj/ptz, as well as the average number of jet partners per Z, rjz, were studied in intervals of ptz, in both pp and PbPb collisions. The rjz is found to be smaller in PbPb than in pp collisions, which suggests that in PbPb collisions a larger fraction of partons, associated with the Z bosons, lose energy and fall below the 30 GeV/c ptj threshold.
A search for events containing four top quarks (ttbar-ttbar) is reported from proton-proton collisions recorded by the CMS experiment at sqrt(s) = 13 TeV and corresponding to an integrated luminosity ...of 2.6 inverse femtobarns The analysis considers the single-lepton (e or mu)+jets and the opposite-sign dilepton (mu+mu-, mu+/- e-/+, or e+e-)+jets channels. It uses boosted decision trees to combine information on the global event and jet properties to distinguish between ttbar-ttbar and ttbar production. The number of events observed after all selection requirements is consistent with expectations from background and standard model signal predictions, and an upper limit is set on the cross section for ttbar-ttbar production in the standard model of 94 fb at 95% confidence level (10.2 times the prediction), with an expected limit of 118 fb. This is combined with the results from the published CMS search in the same-sign dilepton channel, resulting in an improved limit of 69 fb at 95% confidence level (7.4 times the prediction), with an expected limit of 71 fb. These are the strongest constraints on the rate of ttbar-ttbar production to date.
Charge-dependent azimuthal particle correlations with respect to the second-order event plane in pPb and PbPb collisions at a nucleon-nucleon center-of-mass energy of 5.02 TeV have been studied with ...the CMS experiment at the LHC. The measurement is performed with a three-particle correlation technique, using two particles with the same or opposite charge within the pseudorapidity range abs(eta)<2.4, and a third particle measured in the hadron forward calorimeters (4.4< abs(eta)<5). The observed differences between the same and opposite sign correlations, as functions of multiplicity and eta gap between the two charged particles, are of similar magnitude in pPb and PbPb collisions at the same multiplicities. These results pose a challenge for the interpretation of charge-dependent azimuthal correlations in heavy ion collisions in terms of the chiral magnetic effect.
A search is presented for a heavy vector-like quark, decaying into a b quark and a W boson, which is produced singly in association with a light flavor quark and a b quark. The analysis is performed ...using a data sample of proton-proton collisions at a center-of-mass energy of sqrt(s) = 13 TeV collected at the LHC in 2015. The data set used in the analysis corresponds to an integrated luminosity of 2.3 inverse-femtobarns. The search is carried out using events containing one electron or muon, at least one b-tagged jet with large transverse momentum, at least one jet in the forward region of the detector, and missing transverse momentum. No excess over the standard model prediction is observed. Upper limits are placed on the production cross section of heavy exotic quarks: a T quark with a charge of 2/3, and a Y quark with a charge of -4/3. For Y quarks with coupling of 0.5 and B(Y to bW) = 100%, the observed (expected) lower mass limits are 1.40 (1.0) TeV. This is the most stringent limit to date on the single production of the Y vector-like quark.
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