[Safety of patient care on an interprofessional training ward in visceral surgery]. / Sicherheit der Patientenversorgung auf einer viszeralchirurgischen interprofessionellen Ausbildungsstation.

BACKGROUND: Interprofessional training wards (ITW) are increasingly being integrated into teaching and training concepts in visceral surgery clinics. OBJECTIVE: How safe is patient care on an ITW in visceral surgery? MATERIAL AND METHODS: Data collection took place from November 2021 to December 2022. In this nonrandomized prospective evaluation study the frequency and severity of adverse events (AE) in 3 groups of 100 patients each in a tertiary referral center hospital for visceral surgery were investigated. The groups consisted of patients on the ITW and on the conventional ward before and after implementation of the ITW. The Global Trigger Tool (GTT) was used to search for AE. Simultaneously, a survey of the treatment was conducted according to the Picker method to measure patient reported outcome. RESULTS: Baseline characteristics and clinical outcome parameters of the patients in the three groups were comparable. The GTT analysis found 74 nonpreventable and 5 preventable AE in 63 (21%) of the patients and 12 AE occurred before the hospital stay. During the hospital stay 50 AE occurred in the operating theater and 17 on the conventional ward. None of the five preventable AE (in 1.7% of the patients) was caused by the treatment on the ITW. Patients rated the safety on the ITW better than in 90% of the hospitals included in the Picker benchmark cohort and as good as on the normal ward. CONCLUSION: The GTT-based data as well as from the patients' point of view show that patient care on a carefully implemented ITW in visceral surgery is safe.

Anesthesia for Open Radical Retropubic Prostatectomy: A Comparison between Combined Spinal Epidural Anesthesia and Combined General Epidural Anesthesia.

BACKGROUND: Several anesthesiologic regimens can be used for open radical retropubic prostatectomy. The aim of this retrospective analysis was to compare the combined general epidural anesthesia and the combined spinal epidural anesthesia with regard to availability, efficacy, side effects, and perioperative time consumption in a high-volume center. METHODS: A retrospective analysis was performed by querying the electronic medical records of 1207 consecutive patients from the database of our online documentation software. All patients underwent open radical retropubic prostatectomy from 01/2008 to 08/2011 and met the study criteria. Linear and multivariate regression analyses were performed to identify differences in parameters such as time consumption in the operating unit, hemodynamic parameters, volume replacement, and catecholamine therapy. RESULTS: 698 (57.8%) patients have been undergoing open radical retropubic prostatectomy under combined spinal epidural anesthesia and 509 (42.2%) patients by combined general epidural anesthesia. Operating unit (p <0.0001) and post-anesthesia care unit stay (p <0.0001) as well as total hospital stay (p <0.0001) were significantly shorter in the combined spinal epidural anesthesia group. In addition, this group had reduced intraoperative volume need (p <0.0001) as well as lower need of catecholamines (p <0.0001). CONCLUSIONS: This retrospective study suggests that the combined spinal epidural anesthesia seems to be a suitable and efficient anesthesia technique for patients undergoing open radical retropubic prostatectomy. This specific approach reduces time in the operation unit and length of hospital stay.

Comparison of the horizontal diameter to a modeled area of traction in eyes with vitreomacular traction: is the diameter close enough to the truth?

PURPOSE: In daily practice, vitreomacular traction (VMT) is described by the horizontal diameter of its attachment site implying a regular round shape of VMT. We investigated the deviation from this circular area of vitreous traction in patients with VMT. METHODS: A retrospective analysis of optical coherence tomography (OCT) scans was performed. The area of vitreomacular attachment was determined using six radial OCT scans (Ameasured). The assumed circular area of traction was calculated based on measuring the maximal horizontal diameter for comparison (Acircular). RESULTS: Thirty-seven eyes of 37 patients with pure VMT were included. Patients' mean age was 72.8 ± 8.2 years. Mean horizontal VMT diameter was 400.8 ± 230.5 µm (median 361 µm; range 44-991 µm). While there was no difference between mean areas of traction for Acircular and Ameasured (P = 0.93), the individual difference (|Acircular - Ameasured|) was 0.042 (± 0.044) mm2 in mean or relative 73.0% (± 135.8%). A difference of ≥ 30% of Ameasured to Acircular was found in 16 eyes (43.2%) and ≥ 100% in 7 eyes (18.9%), respectively. CONCLUSION: Vitreous attachment sites possess an irregular non-circular shape in a significant number of eyes with VMT. Consequently, the area of traction appears inaccurately described by its horizontal VMT diameter alone. As the area of traction is important for therapeutic recommendation, our results emphasize the need for a more precise description of the area of traction in eyes with VMT.

Phrenic palsy and analgesic quality of continuous supraclavicular vs. interscalene plexus blocks after shoulder surgery.

BACKGROUND: Hemidiaphragmatic palsy is a common consequence of the interscalene brachial plexus block. It occurs less commonly with the supraclavicular approach. Register data suggest that the analgesic quality of a supraclavicular blockade is sufficient for arthroscopic shoulder surgery, although data on the post-operative analgesic effect are lacking. METHODS: After approval by the ethics committee, patients having arthroscopic shoulder surgery under general anaesthesia were randomized to receive a continuous interscalene or supraclavicular blockade. Phrenic nerve function was evaluated through ultrasound examination of the diaphragm in combination with spirometry. Pain scores at rest and activity etc. were determined before catheter insertion, during observation in the post- anaesthesia care unit (PACU) and on post-operative day 1 (POD1). The initial application of 10 ml of ropivacaine 0.2% was followed by continuous application of 4 ml of ropivacaine 0.2%, plus a patient controlled analgesia (PCA) bolus of 4 ml/h. RESULTS: One hundred and twenty patients were randomized, of which 114 data sets were analysed. Complete hemidiaphragmatic paresis occurred in 43% of the interscalene group vs. 24% in the supraclavicular group during PACU stay. Rates of dyspnoea and hoarseness were similar. Horner's syndrome occurred in 21% of the interscalene but only 3% of the supraclavicular group on POD1. Pain scores were comparable for pain at rest and during stress at each time point. CONCLUSIONS: This trial showed a significantly greater incidence of phrenic nerve palsy of the interscalene group in PACU, but not on POD1. Post-operative analgesic quality was similar in both groups. Continuous supraclavicular blockade is a suitable alternative to the continuous interscalene technique.

Risk evaluation for needle-nerve contact related to electrical nerve stimulation in a porcine model.

BACKGROUND: For performing peripheral nerve blocks, the risk for needle-nerve contact (NNC) as an adverse event for low and high current thresholds has not yet been clearly defined when nerve stimulator guided techniques were applied. This experimental study aimed to investigate the risk of NNCs when applying stimulation currents between 0.1 and 2 mA (in increments of 0.1 mA). METHODS: Brachial plexus nerves were exposed surgically in five anesthetized pigs. An insulated needle connected to a nerve stimulator was placed at 10 mm distance to the targeted nerves. Current intensity was adjusted according to randomization (0.1-2.0 mA, increments of 0.1 mA). The needle tip was advanced toward the nerve until a motor response was elicited. The frequencies of NNCs for each of the adjusted current intensities were noted. Risks of NNCs were calculated according to the analysis of 95% confidence intervals (95% CI). RESULTS: We executed 2000 needle placements with stimulation currents ranging from 0.1 to 2.0 mA. The risks for NNC at low current intensities were 0.85 (95% CI, 0.77-0.91) for 0.3 mA and 0.5 (95% CI, 0.4-0.6) for 0.5 mA, respectively. For high current intensities, risks of 0.13 (95% CI, 0.07-0.21) for 0.9 mA and 0.01 (95% CI, 0-0.05) for 1.1 mA were calculated. CONCLUSIONS: In this experimental animal study, a relevant reduction in the risk of NNCs could be observed when high current intensities (0.9-1.1 mA) were applied compared to low current intensities (0.3-0.5 mA).

Multicenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therapy in pancreatic cancer (ATIP).

BACKGROUND: To investigate whether addition of cetuximab to standard adjuvant chemotherapy with gemcitabine improves outcome in pancreatic cancer, specifically whether the rate of disease-free survival (DFS) at 18 months (primary end point) exceeds the previously reported 35% of gemcitabine alone. PATIENTS AND METHODS: Prospective, open-label, multicenter, nonrandomized phase II study in 76 patients with R0- or R1-resected ductal adenocarcinoma of the pancreas included between October 2006 and November 2008. Gemcitabine and cetuximab were administered for 24 weeks. Secondary end points included overall survival (OS) and toxic effect. RESULTS: Seventy-three patients received cetuximab. Median DFS was 10.0 [95% confidence interval (CI) 8.9-13.6] months and the DFS rate at month 18 of 27.1% (16.7%-37.6%) was inferior to 35%. Median OS was 22.4 (18.2-27.9) months. Subgroup analyses revealed a nonsignificant increase in DFS for patients with versus without skin toxic effect ≥ grade 2 (median 14.7 versus 8.3 months, P = 0.073) and wild-type versus mutated K-Ras (median 11.5 versus 9.3 months, P = 0.57). Grade 3/4 toxic effects included neutropenia (11.0%), thrombopenia (7%), skin toxic effect (7%) and allergic reactions (7%). CONCLUSION: Addition of cetuximab to adjuvant gemcitabine does not seem to improve DFS or OS of unstratified pancreatic cancer patients. Trends for improved DFS in patients with wild-type K-Ras and skin toxic effect remain to be confirmed.

Impact of propofol on mid-latency auditory-evoked potentials in children.

BACKGROUND: Propofol is increasingly used in paediatric anaesthesia, but can be challenging to titrate accurately in this group. Mid-latency auditory-evoked potentials (MLAEPs) can be used to help titrate propofol. However, the effects of propofol on MLAEP in children are unclear. Therefore, we investigated the relationship between propofol and MLAEP in children undergoing anaesthesia. METHODS: Fourteen healthy children aged 4-16 yr received anaesthesia for elective surgery. Before surgery, propofol was administered in three concentrations (3, 6, 9 µg ml(-1)) through a target-controlled infusion pump using Kataria and colleagues' model. MLAEPs were recorded 5 min after having reached each target propofol concentration at each respective concentration. Additionally, venous propofol blood concentrations were assayed at each measuring time point. RESULTS: Propofol increased all four MLAEP peak latencies (peaks Na, Pa, Nb, P1) in a dose-dependent manner. In addition, the differences in amplitudes were significantly smaller with increasing propofol target concentrations. The measured propofol plasma concentrations correlated positively with the latencies of the peaks Na, Pa, and Nb. CONCLUSIONS: Propofol affects MLAEP latencies and amplitudes in children in a dose-dependent manner. MLAEP measurement might therefore be a useful tool for monitoring depth of propofol anaesthesia in children.

Dual guidance improves needle tip placement for peripheral nerve blocks in a porcine model.

BACKGROUND: The objective of the study was to evaluate whether the use of ultrasound (US) together with nerve stimulation (USNST) provides a better needle tip position for performing peripheral regional anaesthesia than the use of US or nerve stimulation (NST) alone. METHODS: Needle placements were applied at the brachial plexus and sciatic nerves in 32 anaesthetised pigs. Following needle placement near the target nerve, using either the USNST or the US or NST, a volume of 0.3 ml synthetic resin was injected mimicking a 'test-dose' injection. The primary outcome was the incidence of close needle-to-nerve placement assessed by injectate localisation in direct contact with the nerve epineurium. Secondary endpoints were the incidences of intraneural injection and haematoma formation in direct contact with the target nerve. RESULTS: A total of 611 punctures were performed. The evaluation for the criterion 'close needle placement' revealed significant differences in favour of the USNST group (98.5%) compared with the NST (90.1%) and the US group (81.6%) (P = 0.001). Significant differences were observed regarding 'intraneural needle placement' between the groups as well (USNST, 0.5%; US, 4%; NST, 2.5%; P = 0.034). The incidence of haematoma formation was significantly higher in the NST group (10.8%) than in the US group (2.5%) and in the USNST group (1.5%) (P = 0.001). CONCLUSION: These findings suggest that the USNST approach combines the benefits of the US and the NST techniques in terms of a higher rate of close needle tip placements and a lower incidence of haematoma formation.

Relevance of level I and IIB neck dissection in laryngeal cancer.

OBJECTIVES: Dissection of neck levels I and IIB is time-consuming and can cause comorbidity. This study aimed to determine whether level I and IIB neck dissection was necessary in patients with laryngeal cancer and clinically detectable or nondetectable neck nodes. PATIENTS AND METHODS: This was a retrospective review of 73 patients with laryngeal cancer. Essential clinical data were obtained and analysed to determine the incidence of neck node metastasis in levels I and IIB. RESULTS: Of the 48 patients with no clinically apparent neck nodes, none had level I metastases and only one had level IIB metastases. Of the patients with clinically detectable neck nodes, three of 21 patients had level I metastases and three of 25 patients had level IIB metastases; these six patients also had additional metastases in level IIA. CONCLUSION: Dissection of neck levels I and IIB is justifiable in laryngeal cancer patients with clinically detectable neck nodes and suspicious lymph nodes in the respective level or level IIA. However, in patients without clinically detectable neck nodes, preservation of levels I and IIB is oncologically safe, economical and reduces the risk of comorbidity.

Effects of increasing sevoflurane MAC levels on mid-latency auditory evoked potentials in infants, schoolchildren, and the elderly.

BACKGROUND: Detection of mid-latency auditory evoked potentials (MLAEPs) is a technology to monitor central nervous structures. As seen in adults and children, general anaesthesia influences the MLAEP latencies. MLAEP detection seems to be a promising tool to assess different levels of anaesthesia depth in adults and children. METHODS: MLAEPs were recorded in 10 infants (2 months-3 yr), 12 schoolchildren (6-14 yr), and 10 elderly (75-89 yr) under general anaesthesia with increasing concentrations of sevoflurane at steady state. In addition, MLAEPs were detected before and after the application of sufentanil. RESULTS: At all different ages, MLAEP latencies increased significantly with higher volume percentages of sevoflurane. These results were also detectable when MAC values of sevoflurane were compared with MLAEP peaks. An age-dependent effect could be displayed as elderly people need lower absolute sevoflurane concentrations to achieve the same MLAEP peak increase. Overall, the application of sufentanil under steady-state sevoflurane application at 1 MAC did not importantly affect the MLAEP latencies. CONCLUSIONS: MLAEP latencies increase at the influence of sevoflurane in a dose-dependent manner and in relation to age. These results imply that MLAEP detection is a reasonable tool for monitoring hypnotic effects at all ages. Further studies are required to standardize MLAEP alterations related to effects of medication used for general anaesthesia at all different ages.

Systematic evaluation of the highest current threshold for regional anaesthesia in a porcine model.

BACKGROUND: The purpose of this study was to determine systematically the highest minimal stimulation current threshold for regional anaesthesia in pigs. METHODS: In an established pig model for regional anaesthesia, needle placements applying electric nerve stimulation were performed. The primary outcome was the frequency of close needle to nerve placements as assessed by resin injects and subsequent anatomical evaluation. Following a statistical model (continual reassessment method), the applied output currents were selected to limit the necessary number of punctures, while providing guidance towards the highest output current range. RESULTS: Altogether 186 punctures were performed in 11 pigs. Within the range of 0.3-1.4 mA, no distant needle to nerve placement was found. In the range of 1.5-4.1 mA, 43 distant needle to nerve placements occurred. The range of 1.2-1.4 mA was the highest interval that resulted in a close needle to nerve placement rate of > or =95%. CONCLUSIONS: In the range of 0.3-1.4 mA, all resin deposition was found to be adjacent to nerve epineurium. The application of minimal current intensities up to 1.4 mA does not obviously lead to a reduction of epineural injectate contacts in pigs. These findings suggest that stimulation current thresholds up to 1.4 mA result in equivalent needle tip localisation in pigs.

Meta-analysis of the prognostic significance of perinodal spread in head and neck squamous cell carcinomas (HNSCC) patients.

To assess the risk factor of capsular rupture for individual prognosis and potential therapeutic decision making, the present meta-analysis elaborated the prognostic significance of perinodal spread in a large group of patients suffering from head and neck squamous cell carcinomas (HNSCC). A review of the published literature was conducted, and fixed and random effects models were applied for estimation of the summarised odds ratio and 95% confidence intervals, including a test for homogeneity of the odds ratios. Study methodology allowed the enrollment of only nine studies of 115 published papers. Excluded studies lacked regarding primary tumour location, number and location of lymph node metastases, values on five-year survival, or adequate follow-up data. A summarised odds ratio of 2.7 leads to the conclusion that perinodal spread negatively impacts the five-year survival. The lower confidence limit of more than 2 also supports the concept that perinodal spread significantly reduces (doubled risk) the five-year-survival. These results support the conclusion that perinodal spread is a significant adverse risk factor for survival in patients with HNSCC.

[What effect does the hydroxyapatite coating have in cementless knee arthroplasty?]. / Welchen Effekt hat die Hydroxylapatitbeschichtung beim zementfreien Kniegelenkersatz? Eine prospektiv randomisierte RSA-Langzeitstudie über 9 Jahre.

The goal of this study was to compare the migration of noncemented diffusion sintered titanium fibermesh-coated tibial components with (HA group) and without (non-HA group) additional hydroxyapatite coating. For this purpose digital radiostereometry (DIRSA) was used to compare the migration after 2 and 9 years for the two groups. After 2 years the mean maximum subsidence of the HA-coated components (0.24+/-0.18 mm) was about one-half of the mean maximum subsidence of the non-HA-coated group (0.55+/-0.55 mm). After 9 years the maximum subsidence of the HA-coated components was still smaller, but not as pronounced as before. The same trend was also found for the endpoint maximum total point motion (MTPM). After 2 years the mean MTPM of the HA-coated components was 0.66+/-0.38 mm and of the non-HA group 0.73+/-0.50 mm. After 9 years the mean MTPM for the HA-coated components was 0.54+/-0.15 mm and for the non-HA-coated components 0.74+/-0.20 mm. None of the HA-coated tibial components but one of the non-HA group had to be revised and exchanged due to aseptic loosening.

Prospective pilot study of neoadjuvant chemotherapy with 5-fluorouracil, folinic acid and oxaliplatin in resectable liver metastases of colorectal cancer. Analysis of 42 neoadjuvant chemotherapies.

PURPOSE: Since there are currently no data available from a prospective trial, the primary objective of this prospective study was to investigate whether the rate of R0-liver resections without morbidity would be at least 50 % in patients with neoadjuvant chemotherapy for colorectal liver metastases. PATIENTS AND METHODS: 42 patients were treated with a biweekly FOLFOX regimen. Chemotherapy consisted of a 2-hour infusion of folinic acid (FOL) 500 mg/m2, followed by a 24-hour infusion of 5- fluorouracil (F) 2000 mg/m2 daily for two days. Oxaliplatin (OX) 85 mg/m 2 was given simultaneously with FOL. Treatment allocation was randomized with either 3 or 6 cycles for the final 30 patients. A liver resection was performed 2 to 5 weeks after the final infusion. RESULTS: An objective response was observed in 20 of 42 patients (response rate was 27 % higher after 6 cycles). Liver resection (R0) could be performed in 34 patients. Postoperative complications were reported in 14 patients (13 occurring within 30 days after resection) and severe complications in 5 cases (including two deaths after extended resection). Liver failure and persistent biliary fistula were the most frequently documented complications. There was no relevant difference in safety criteria between 3 and 6 applications. CONCLUSION: The use of neoadjuvant chemotherapy in resectable liver metastases induced significant remissions without increasing morbidity. The rate of severe complications and cases of no R0-resection in this study was 31 % and was with that significantly lower than 50 % (95 % CI 17.6 %-47.1 %). The risk to the patient is therefore acceptable when undergoing neoadjuvant treatment in a prospective intergroup trial.

Extracorporeal shock wave therapy in the treatment of lateral epicondylitis : a randomized multicenter trial.

BACKGROUND: On the basis of observational trials, numerous investigators have recommended extracorporeal shock wave therapy as an alternative treatment for chronic lateral epicondylitis of the elbow. However, there has been no evidence of its efficacy from well-designed randomized clinical trials. The objective of this study was to find out whether extracorporeal shock wave therapy in combination with local anesthesia was superior to placebo therapy in combination with local anesthesia. METHODS: A randomized multicenter trial with a parallel-group design was conducted. Following administration of local anesthesia, either extracorporeal shock wave therapy with three treatments of 2000 pulses each and a positive energy flux density (ED+) of 0.07 to 0.09 mJ/mm (2) or placebo therapy was applied on an outpatient basis. Treatment allocation was blinded for patients and for observers. The primary end point was based on the rate of success, as determined with the Roles and Maudsley score and whether additional treatment was required, twelve weeks after the intervention. Crossover was possible after assessment of the primary end point. Secondary end points were the Roles and Maudsley score, subjective pain rating, and grip strength after six and twelve weeks and after twelve months. The planned number of 272 patients was included in the study. RESULTS: The primary end point could be assessed for 90.8% of the patients. The success rate was 25.8% in the group treated with extracorporeal shock wave therapy and 25.4% in the placebo group, a difference of 0.4% with a 95% confidence interval of -10.5% to 11.3%. Similarly, there was no relevant difference between groups with regard to the secondary end points. Improvement was observed in two-thirds of the patients from both groups twelve months after the intervention. Few side effects were reported. CONCLUSIONS: Extracorporeal shock wave therapy as applied in the present study was ineffective in the treatment of lateral epicondylitis. The previously reported success of this therapy appears to be attributable to inappropriate study designs. Different application protocols might improve clinical outcome. We recommend that extracorporeal shock wave therapy be applied only in high-quality clinical trials until it is proved to be effective.

Does treatment of varicocele improve male fertility? results of the 'Deutsche Varikozelenstudie', a multicentre study of 14 collaborating centres.

Treatment of varicocele is suggested in infertile men if sperm parameter values are abnormal. The effectiveness of the treatment with respect to fertility remains to be clarified. A multicentre, prospective randomized study on varicocele treatment in infertile men to demonstrate the superiority of sclerotization of the varicocele in preventing persistence, was started in 1995 with the collaboration of 15 German andrological centres. The primary endpoint was the incidence of pregnancy 1 year after randomisation. The number of cases needed to achieve the goal of the study was calculated at 460. However, three years after starting the study, only 67 patients had been randomized. Different reasons contributed to the poor recruitment. There was no significant increase in pregnancy rate in the treated group, compared to the controls, the confidence interval being 20.8% to 15.7%. The authors would like to encourage further collaborative study groups to start another prospective, randomized study with the aim of avoiding the costs and risks of varicocele treatment when its success remains unclear.

[Comparison of extracorporeal shockwave therapy (ESWT) with roentgen irradiation in supraspinatus tendon syndrome--a prospective randomized single-blind parallel group comparison]. / Vergleich der extrakorporalen Stosswellentherapie (ESWT) mit der Röntgenreizbestrahlung beim Supraspinatussehnensyndrom--Ein prospektiver randomisierter einfachblinder Parallelgruppenvergleich.

AIM: Extracorporal shock wave therapy (FSWT) is applied in the case of supraspinatus tendinitis if conservative therapies have failed. So far there has been no controlled study comparing the effectiveness of ESWT with an established conservative method of therapy such as X-ray stimulation radiotherapy. METHOD: Thirty patients with chronic supraspinatus tendinitis were admitted into the prospective randomised study. After randomisation, the patients were treated either three times with 2000 pulses (energy flux density ED+ 0.33 mJ/mm2) with a Storz Minilith SL1 after one week, or with X-ray stimulation radiotherapy with 6 x 0.5 Gy on the ICRU reference point (1 neutral fraction/day) with cobalt 60 gamma rays. Primary endpoint was the age-corrected constant score. RESULTS: In the ESWT group the average age-corrected constant score rose from 50.1 points before ESWT to 91.5 points after 12 weeks and to 97.8 after 52 weeks. In the radiotherapy group it improved from 47.6 through 79.5 points to 87.4 points. CONCLUSION: No statistically significant differences were proven between ESWT and radiotherapy. ESWT appears to be at least equivalent to radiotherapy in treating chronic supraspinatus tendinitis syndrome and can avoid a dose of radiation for patients and staff. A comprehensive randomised study is, however necessary to ensure the equivalence of ESWT.