Predictors for severe persisting pain in rheumatoid arthritis are associated with pain origin and appraisal of pain.

OBJECTIVES: To determine the proportion of patients with rheumatoid arthritis (RA) with severe persisting pain and to identify predictive factors despite treatment-controlled disease activity. METHODS: This prospective multicentre study included outpatients with RA scheduled for escalation of anti-inflammatory treatment due to active disease and severe pain (Disease Activity Score 28 (DAS28)>3.2 and Visual Analogue Scale (VAS)>50). At week 24, patients were stratified into reference group (DAS28 improvement>1.2 or DAS28≤3.2 and VAS pain score<50), non-responders (DAS28 improvement≤1.2 and DAS28>3.2, regardless of VAS pain score) and persisting pain group (DAS28 improvement>1.2 or DAS28≤3.2 and VAS pain score≥50). The former two subgroups ended the study at week 24. The latter continued until week 48. Demographic data, DAS28-C reactive protein, VAS for pain, painDETECT Questionnaire (PD-Q) to identify neuropathic pain (NeP) and the Pain Catastrophising Scale were assessed and tested for relation to persisting pain. RESULTS: Of 567 patients, 337 (59.4%) were classified as reference group, 102 (18.0%) as non-responders and 128 (22.6%) as patients with persisting pain. 21 (8.8%) responders, 28 (35.0%) non-responders and 27 (26.5%) persisting pain patients tested positive for NeP at week 24. Pain catastrophising (p=0.002) and number of tender joints (p=0.004) were positively associated with persisting pain at week 24. Baseline PD-Q was not related to subsequent persisting pain. CONCLUSIONS: Persisting and non-nociceptive pain occur frequently in RA. Besides the potential involvement of NeP, pain catastrophising and a higher number of tender joints coincide with persisting pain.

The impact of C-reactive protein levels on the effectiveness of upadacitinib in patients with rheumatoid arthritis: a 12-month prospective, non-interventional German study.

OBJECTIVES: We investigated whether the effectiveness of upadacitinib in rheumatoid arthritis (RA) treatment is affected by baseline CRP levels in a real-world setting. METHODS: UPwArds was a prospective, non-interventional study. Patients had moderate-to-severe RA and an inadequate response or intolerance to ≥1 disease-modifying anti-rheumatic drug (DMARD). The primary endpoint was clinical remission (Clinical Disease Activity Index [CDAI] ≤2.8) at 6 months. Secondary endpoints at 12 months included clinical remission and low disease activity assessed by CDAI and Simple Disease Activity Index criteria, DAS28-CRP <2.6/≤3.2, and patient-reported outcomes. The impact of baseline CRP levels (normal vs. above the upper limit of normal [ULN]) on primary and secondary endpoints was evaluated. The effect of concomitant MTX and prior inadequate response to biologic or targeted synthetic DMARDs (b/tsDMARD-IR) on the effectiveness of upadacitinib was also assessed. Safety was evaluated through 12 months. RESULTS: 518 patients were included in the effectiveness analyses. At 6 months, 24.4% of patients achieved the primary endpoint (CDAI ≤2.8). At 12 months, similar proportions of patients with normal CRP and CRP above the ULN at baseline achieved CDAI ≤2.8 (27.3% and 29.1%) and other key secondary endpoints. The effectiveness of upadacitinib was comparable with and without concomitant MTX and in b/tsDMARD-naive and b/tsDMARD-IR patients. The safety results were consistent with the known safety profile of upadacitinib; no new safety signals were identified. CONCLUSIONS: Upadacitinib therapy was effective for RA in a real-world setting. Baseline CRP levels had no significant impact on the effectiveness of upadacitinib.

Robot-assisted transthoracic hybrid esophagectomy versus open and laparoscopic hybrid esophagectomy: propensity score matched analysis of short-term outcome.

PURPOSE: Minimally invasive en-bloc esophagectomy is associated with a reduction of postoperative morbidity. This was demonstrated for both total minimally invasive and hybrid esophagectomy. However, little is known about any benefits of robotic assistance compared to the conventional minimally invasive technique, especially in hybrid procedures. METHODS: For this retrospective study, all consecutive patients who had undergone elective esophagectomy with circular stapled intrathoracic anastomosis using the open and the minimally invasive hybrid technique at the University Hospital Magdeburg, from January 2010 to March 2021 were considered for analysis. RESULTS: In total, 137 patients (60.4%) had undergone open esophagectomy. In 45 patients (19.8%), the laparoscopic hybrid technique and in 45 patients (19.8%), the robot-assisted hybrid technique were applied. In propensity score matching analysis comparing the open with the robotic hybrid technique, significant differences were found in favor of the robotic technique (postoperative morbidity, p < 0.01; hospital length of stay, p < 0.01; number of lymph nodes retrieved, p = 0.048). In propensity score matching analysis comparing the laparoscopic with the robotic hybrid technique, a significant reduction of the rate of postoperative delayed gastric emptying (p = 0.02) was found for patients who had undergone robotic esophagectomy. However, the operation time was significantly longer (p < 0.01). CONCLUSIONS: En-bloc esophagectomy using the robotic hybrid technique is associated with a significant reduction of postoperative morbidity and of the hospital length of stay when compared to the open approach. However, when compared to the laparoscopic hybrid technique, only few advantages could be demonstrated.

Inter- and intraobserver reliabilities and critical analysis of the osteoporotic fracture classification of osteoporotic vertebral body fractures.

PURPOSE: The Osteoporotic Fracture Working Group (Spine Division of the German Orthopaedic and Trauma Society) has developed a classification system for osteoporotic thoracolumbar fractures, namely the osteoporotic fracture (OF) classification system. The purpose of this study was to determine the inter- and intraobserver reliabilities of the OF classification system for osteoporotic vertebral body fractures (VFs) at a level-one trauma centre. METHODS: Conventional radiography, magnetic resonance imaging (MRI), and computed tomography (CT) scans of 54 consecutive women who sustained an osteoporotic VF were analysed by six orthopaedic traumatologists with varying levels of experience. The inter- and intraobserver reliabilities of the OF classification system were determined using intraclass correlation coefficients (ICCs) and Cohen's kappa. RESULTS: The overall interobserver reliability of the OF classification system was good (ICC, 0.62 [0.51, 0.72]). The intraobserver reliability was found to be substantial (overall weighted Cohen's kappa estimate [95% confidence interval {CI}] = 0.74 [0.67, 0.80]) and better when the radiography, MRI, and CT scans were assessed together than when only the radiography and MRI scans were evaluated, although the difference was not significant. CONCLUSION: The OF classification system is easy to use. It shows good interobserver reliability and substantial intraobserver reliability if diagnostic prerequisites (conventional radiography, MRI, and CT scans) are met.

Neurological consultations via telemedicine for specialized outpatient palliative care (SOPC) at home and in hospice (TANNE project): study protocol for a randomized controlled trial.

BACKGROUND: Neurological diseases cause numerous challenges in palliative care. Telemedicine may improve the access to specialized expertise in neurology for patients, their relatives, and palliative care physicians. The TANNE study offers teleconsultations by a hospital-based neuropalliative center for specialized outpatient palliative care (SOPC) and hospices. A prospective, partially randomized, controlled trial aims at generating evidence for clinical improvements, quality of life, and cost efficiency. METHODS: SOPC and hospice teams in Bavaria, Germany, are partially randomized to one of two study arms, namely a treatment group with teleconsultations by specialists for neurology and palliative medicine or to a control group with interventions after a 12-months delay. Individual and population-based measures are assessed with a mixed-methods design in order to evaluate the medical effects, the potential for implementation in standard care, and health economic aspects. The primary outcome consists of the mean change difference between groups in the Integrated Palliative Care Outcome Scale (IPOS), which physicians assess before and after treatment of a neurological event. Besides, several secondary outcomes are investigated, including quality of life, which is measured with the revised McGill Quality of Life Questionnaire (McGill QOL-R) as well as items regarding general and health-related quality of life. Further secondary outcomes include the concrete progress of the neurological signs and symptoms; the subjective change in well-being since the start of the treatment of the neurological diseases from the perspectives of patients, their relatives, as well as medical and nursing professionals; as well as patient, professional, and caregiver satisfaction with the teleconsultations. Moreover, a health economic evaluation compares group differences regarding hospital visits and emergency calls with utilization measurements. DISCUSSION: The TANNE trial provides a comprehensive and complex evaluation design for teleconsultations in neuropalliative care. Ethical considerations need to take the patients' vulnerability into account. The project promises to substantially broaden the width of health care services and to improve the quality of life for deserving patients. TRIAL REGISTRATION: German Clinical Trials Register ( www.germanctr.de [July 17, 2022], DRKS ID: DRKS00027436. Registered February 10th, 2022, retrospectively registered. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00027436 [July 17, 2022].

First-in-Human Clinical Application of the Medyria TrackCath System in Endovascular Repair of Complex Aortic Aneurysms (ACCESS Trial): A Prospective Multicenter Single-Arm Clinical Trial.

PURPOSE: The Medyria TrackCath Catheter (MedTCC) is an innovative, thermal convection-based blood flow velocity (BFV) tracking catheter that may be used during complex aortic endovascular procedures for identification and catheterization of target orifices. The ACCESS Trial analyzes the safety and performance of the MedTCC for targeted vessel catheterization to generally evaluate the feasibility of thermal convection-based BFV. MATERIALS AND METHODS: We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers. During these procedures, the MedTCC was advanced over a guidewire through the femoral access. The D-shape was enfolded in the reno-visceral part of the aorta and target orifices were identified and catheterized with a guidewire via the side port of the MedTCC through BFV tracking. BFV measurements were performed at baseline (Baseline-BFV), alignment to the orifice (Orifice-BFV), and following catheterization (Confirmation-BFV) to prove correct identification and catheterization of target orifices. The procedural success rate, the catheterization success rate, procedure-related parameters, and (serious) adverse events ((S)AE) during the follow-up were analyzed. RESULTS: A total of 38 patients were included in the safety group (SG) and 26 in the performance group (PG). The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG). The MedTCC reliably measured BFV changes indicated by significant differences in BFV between Baseline-BFV and Orifice-BFV (p<0.05). Median (interquartile range; IQR) fluoroscopy time per orifice was 5.0 (1.5-8.5) minutes [total surgery 49 (26-74) minutes], median (IQR) contrast agent used per orifice was 1.0 (0-5.0) mL [total surgery 80 (40-100) mL], and median (IQR) MedTCC-based procedural time was 3.0 (2.0-6.0) minutes. There was no device-related SAE. CONCLUSIONS: The ACCESS Trial suggests that BFV measurement allows for reliable target orifice identification and catheterization. The use of MedTCC is safe and generates short fluoroscopy time and low contrast agent use, which in turn might facilitate complex endovascular procedures.

Short-term outcome after robot-assisted hiatal hernia and anti-reflux surgery-is there a benefit for the patient?

PURPOSE: The robotic system was introduced to overcome the technical limitations of conventional laparoscopy. For complex oncological operations, it appears to offer further advantages. With regard to hiatal hernia repair, its role has yet to be determined. METHODS: All consecutive patients who received elective laparoscopic or robot-assisted hiatal hernia repair at a single institution between January 2016 and July 2020 were retrospectively evaluated. We compared both techniques with particular focus on their short-term outcome. A propensity score-matched comparison considering clinical and surgical covariates was also performed between the two groups. RESULTS: 140 patients were included, and 55 (39.3%) underwent a robot-assisted procedure. The baseline demographics and the frequency of previous abdominal operations were comparable for both groups. The size of the hiatal hernia did not differ significantly between the groups (p = 0.06). The mean operative time was significantly longer for the robot-assisted procedure (149 vs. 125 min; p < 0.01) but decreased markedly during the study period. By contrast, no significant differences were observed in terms of conversion rate (p = 1.0) and blood loss (p = 0.25). Likewise, the postoperative morbidity was comparable for both groups (10.9 vs. 12.9; p = 0.79). The hospital length of stay was not significantly different between the laparoscopic and robotic group (4.0 vs. 3.6 days; p = 0.2). After propensity score-matching, 48 patients were identified for each group. Except for the operative time, no other significant differences were found. Thus, the results of the univariate analysis were confirmed. CONCLUSION: Our initial results failed to demonstrate a clear advantage of the robotic technique in patients with refractory gastroesophageal reflux disease and/or symptomatic hiatal hernias.

Smaller Inguinal Hernias are Independent Risk Factors for Developing Chronic Postoperative Inguinal Pain (CPIP): A Registry-based Multivariable Analysis of 57, 999 Patients.

OBJECTIVE: Impact of inguinal hernia defect size as stratified by the European Hernia Society (EHS) classification I to III on the rate of chronic postoperative inguinal pain (CPIP). BACKGROUND: CPIP is the most important complication after inguinal hernia repair. The impact of hernia defect size according to the EHS classification on CPIP is unknown. METHODS: In total, 57,999 male patients from the Herniamed registry undergoing primary unilateral inguinal hernia repair including a 1-year follow-up were selected between September 1, 2009 and November 30, 2016. Using multivariable analysis, the impact of EHS inguinal hernia classification (EHS I vs EHS II vs EHS III and/or scrotal) on developing CPIP was investigated. RESULTS: Multivariable analysis revealed for smaller inguinal hernias a significant higher rate of pain at rest [EHS I vs EHS II: odds ratio, OR = 1.350 (1.180-1.543), P < 0.001; EHS I vs EHS III and/or scrotal: OR = 1.839 (1.504-2.249), P < 0.001; EHS II vs EHS III and/or scrotal: OR = 1.363 (1.125-1.650), P = 0.002], pain on exertion [EHS I vs EHS II: OR = 1.342 (1.223-1.473), P < 0.001; EHS I vs EHS III and/or scrotal: OR = 2.002 (1.727-2.321), P < 0.001; EHS II vs EHS III and/or scrotal: OR = 1.492 (1.296; 1.717), P < 0.001], and pain requiring treatment [EHS I vs EHS II: OR = 1.594 (1.357-1.874), P < 0.001; EHS I vs EHS III and/or scrotal: OR = 2.254 (1.774-2.865), P < 0.001; EHS II vs EHS III and/or scrotal: OR = 1.414 (1.121-1.783), P = 0.003] at 1-year follow-up. Younger patients (<55 y) revealed higher rates of pain at rest, pain on exertion, and pain requiring treatment (each P < 0.001) with a significantly trend toward higher rates of pain in smaller hernias. CONCLUSIONS: Smaller inguinal hernias have been identified as an independent patient-related risk factor for developing CPIP.

Quality of electronic treatment records and adherence to prophylaxis in haemophilia and von Willebrand disease: Systematic assessments from an electronic diary.

INTRODUCTION: HaemoassistTM 2 is an electronic system designed for people with bleeding disorders and their physicians to record prophylactic infusions and treatment of bleeds. It aims to improve adherence by permitting reminders and accuracy of documentation by facilitating real-time reporting. AIM: To assess documentation quality and adherence to prophylactic regimens in patients with haemophilia A, haemophilia B or von Willebrand disease who are using HaemoassistTM 2. METHODS: Ten centres enrolled consecutive patients, who had been using HaemoassistTM 2 for ≥ 3 months (Cohort 1, 'quality of documentation'). Of these, patients who had a specified prophylactic regimen in HaemoassistTM 2 for ≥ 3 months were eligible for inclusion in Cohort 2 ('adherence to prophylaxis'). RESULTS: Cohort 1 comprised 796 patients (71% with severe haemophilia A; median 20.5 months of HaemoassistTM 2 use). The most common method of documentation for patients was using the mobile app; the median time between infusion and documentation was 4 hours using the app, compared with 85 hours using a web portal on a stationery device. The median total annualised number of infusions was consistent in the first and last 3 months of documentation (128; IQR: 70-184 and 120; IQR 64-176, respectively). Cohort 2 comprised 202 patients (79% severe haemophilia A; median of 13 months on prophylactic regimen in HaemoassistTM 2). The rate of adherence to prophylaxis was 83%; median deviation between planned and actual infusion time was ± 2 hours. CONCLUSION: HaemoassistTM 2 was used consistently over prolonged periods of time and allowed for precise analysis of adherence to prophylaxis.

Surgical treatment of lateral and posterior process fractures of the talus: Mid-term results of 15 cases after 7 years.

BACKGROUND: We retrospectively evaluated the mid-term results of surgery for talar process fractures (lateral and posterior processes) and exploratively analyzed parameters that potentially impact treatment outcomes. METHODS: Fifteen patients who underwent internal fixation (January 2000 to December 2015) were examined for radiological and clinical functional outcomes. The independent parameters evaluated were age, sex, extent of general injury, soft-tissue damage, surgical latency, and fracture type. RESULTS: All fractures healed completely. Three patients developed osteoarthritis. The American Orthopaedic Foot and Ankle Society Ankle/Hindfoot Scale score was 79.5±18.6, the Functional Foot Index score was 31.1±31.4, and the physical and mental component summary scores of the Short Form 36, version 2, were 46.6±11.8 and 50.3±9.1, respectively. No influence on the above scores was determined. CONCLUSIONS: The clinical outcomes of internal fixation of talar process fractures were good. Delayed surgical treatment (≥14days) did not significantly lead to poorer outcomes in our patients.

Lichtenstein Versus Total Extraperitoneal Patch Plasty Versus Transabdominal Patch Plasty Technique for Primary Unilateral Inguinal Hernia Repair: A Registry-based, Propensity Score-matched Comparison of 57,906 Patients.

OBJECTIVE: Outcome comparison of the Lichtenstein, total extraperitoneal patch plasty (TEP), and transabdominal patch plasty (TAPP) techniques for primary unilateral inguinal hernia repair. BACKGROUND: For comparison of these techniques the number of cases included in meta-analyses of randomized controlled trials is limited. There is therefore an urgent need for more comparative data. METHODS: In total, 57,906 patients with a primary unilateral inguinal hernia and 1-year follow up from the Herniamed Registry were selected between September 1, 2009 and February 1, 2015. Using propensity score matching, 12,564 matched pairs were formed for comparison of Lichtenstein versus TEP, 16,375 for Lichtenstein versus TAPP, and 14,426 for TEP versus TAPP. RESULTS: Comparison of Lichtenstein versus TEP revealed disadvantages for the Lichtenstein operation with regard to the postoperative complications (3.4% vs 1.7%; P < 0.001), complication-related reoperations (1.1% vs 0.8%; P = 0.008), pain at rest (5.2% vs 4.3%; P = 0.003), and pain on exertion (10.6% vs 7.7%; P < 0.001). TEP had disadvantages in terms of the intraoperative complications (0.9% vs 1.2%; P = 0.035). Likewise, comparison of Lichtenstein versus TAPP showed disadvantages for the Lichtenstein operation with regard to the postoperative complications (3.8% vs 3.3%; P = 0.029), complication-related reoperations (1.2% vs 0.9%; P = 0.019), pain at rest (5% vs 4.5%; P = 0.029), and on exertion (10.2% vs 7.8%; P < 0.001). CONCLUSIONS: TEP and TAPP were found to have advantages over the Lichtenstein operation.

Outcome of laparoscopic paraesophageal hernia repair in octogenarians: a registry-based, propensity score-matched comparison of 360 patients.

BACKGROUND: Paraesophageal hernias (PEH) tend to occur in elderly patients and the assumed higher morbidity of PEH repair may dissuade clinicians from seeking a surgical solution. On the other hand, the mortality rate for emergency repairs shows a sevenfold increase compared to elective repairs. This analysis evaluates the complication rates after elective PEH repair in patients 80 years and older in comparison with younger patients. METHODS: In total, 3209 patients with PEH were recorded in the Herniamed Registry between September 1, 2009 and January 5, 2018. Using propensity score matching, 360 matched pairs were formed for comparative analysis of general, intraoperative, and postoperative complication rates in both groups. RESULTS: Our analysis revealed a disadvantage in general complications (6.7% vs. 14.2%; p = 0.002) for patients ≥ 80 years old. No significant differences were found between the two groups for intraoperative (4.7% vs. 5.8%, p = 0.627) and postoperative complications (2.2% vs. 2.8%, p = 0.815) or for complication-related reoperations (1.7% vs. 2.2%, p = 0.791). CONCLUSIONS: Despite a higher risk of general complications, PEH repair in octogenarians is not in itself associated with increased rates of intraoperative and postoperative complications or associated reoperations. Therefore, PEH repair can be safely offered to elderly patients with symptomatic PEH, if general medical risk factors are controlled.

Small and Laterally Placed Incisional Hernias Can be Safely Managed with an Onlay Repair.

INTRODUCTION: In meta-analyses and systematic reviews, clear advantages have been identified for the sublay versus onlay technique for treatment of incisional hernias. Nonetheless, an expert panel has noted that the onlay mesh location may be useful in certain settings. MATERIALS AND METHODS: First, unadjusted analysis of data from the Herniamed Registry was performed to compare 6797 sublay operations with 1024 onlay operations for repair of incisional hernias. Then, using propensity score matching to account for the influence of variables age, gender, ASA score, BMI, risk factors, preoperative pain, defect size, and defect localization, 1016 pairs were formed and compared with each other. RESULTS: Unadjusted analysis revealed that the onlay operation was used significantly more often for small defects, lateral defect localization, and in women. After comparing the propensity score-matched pairs, no significant difference was found between the sublay and onlay technique in the outcome criteria intra- and postoperative complications, general complications, complication-related reoperations, pain at rest, pain on exertion, chronic pain requiring treatment, and recurrence on 1-year follow-up. But that was true only for this carefully selected patient collective. CONCLUSION: In a selected patient collective with small and lateral incisional hernias and with a large proportion of women, outcomes obtained for the onlay and sublay techniques do not differ significantly.

Does coagulopathy, anticoagulant or antithrombotic therapy matter in incisional hernia repair? Data from the Herniamed Registry.

BACKGROUND: A considerable number of patients undergoing incisional hernia repair are on anticoagulant or antiplatelet therapy or have existing coagulopathy which may put them at higher risk for postoperative bleeding complications. Data about the optimal treatment of these patients are sparse. This analysis attempts to determine the rate of postoperative bleeding complications following incisional hernia repair and the consecutive rate of reoperation among patients with coagulopathy or receiving antiplatelet and anticoagulant therapy (higher risk group) compared to patients who do not have a higher risk (normal risk group). METHODS: Out of the 43,101 patients documented in the Herniamed Registry who had an incisional hernia repair, 6668 (15.5%) were on anticoagulant or antithrombotic therapy or had existing coagulopathy. The implication of that higher risk profile for onset of postoperative bleeding was investigated in multivariable analysis. Hence, other influential variables were identified. RESULTS: The rate of postoperative bleeding in the higher risk group was 3.9% (n = 261) and significantly higher compared to the normal risk group at 1.6% (n = 564) (OR 2.001 [1.699; 2.356]; p < 0.001). Additionally, male gender, use of drains, larger defect size, open incisional hernia repair, lower BMI, and higher ASA score significantly increased the risk of postoperative bleeding. The rate of reoperations due to postoperative bleeding was significantly increased in the higher risk group compared to the normal risk group (2.4 vs. 1.0%; OR 1.217 [1.071; 1.382]; p = 0.003). Likewise, the postoperative general complication rate (6.04 vs. 3.66%; p < 0.001) as well as the mortality rate (0.46 vs. 0.17%; p < 0.001) were significantly higher in the higher risk group. CONCLUSIONS: Patients with anticoagulant or antiplatelet therapy or existing coagulopathy who undergo incisional hernia repair have a significantly higher risk for onset of postoperative bleeding. The risk of bleeding complications and complication-related reoperations seems to be lower after laparoscopic intraperitoneal onlay mesh.

Evaluation of a cancer patient navigation program ("Onkolotse") in terms of hospitalization rates, resource use and healthcare costs: rationale and design of a randomized, controlled study.

BACKGROUND: Concepts for the nursing and care of cancer patients through a "navigation service" have attracted much interest. However, there is still room for improvement in terms of their funding and coverage. The Saxon Cancer Society designed a prospective, randomized, multicenter, longitudinal study with a view to determining the positive effects of a cancer patient navigator program. The objective of this ongoing study is to evaluate the impact of the cancer patient navigation program on cancer patients and cost bearers in Germany. METHODS: The study population in this evaluation comprises cancer patients with gastric carcinoma, pancreatic carcinoma, colorectal cancer, melanoma or gynecological cancer who have been hospitalized at least once at one of the study centers as well as their relatives, outpatient and inpatient physicians, and cancer nurses. It is planned to randomize 340 cancer patients (stomach, colonic/rectal cancer, gynecological cancer, melanoma) at five centers to an intervention group (care by patient navigators based on standardized operating procedures) or a control group in a one-to-one ratio. The primary target parameter is the number of hospitalizations within the 12-month intervention period. The participants are asked to complete various questionnaires on patient-related outcomes at baseline and at 3 and 12 months (SF 36, HADS, PAM 13, and others). Data on drug therapy, utilization of health services, and medical expenses will also be analyzed. DISCUSSION: For the first time, the study will provide data on the effectiveness of a patient support program in cancer care in Germany from a randomized trial with a high level of evidence. TRIAL REGISTRATION: The study has been registered under DRKS00013199 in the German Clinical Trials Register.

[Roux-Y-Gastric Bypass for Morbid Obesity in Adolescents: Is it as Safe and Effective as in Obese Adults?] / Der Roux-Y-Magenbypass zur Therapie der Adipositas bei Jugendlichen: Analyse des Gewichtsverlaufs und des Einflusses auf Komorbiditäten im Vergleich zu adipösen Erwachsenen.

BACKGROUND: Obesity is one of the major challenges of the 21st century. There is also an increasing incidence of obesity in adolescents. Bariatric surgery has been proven safe and effective in obese adults. In adolescents, these operations are still subject to controversy. Current evidence is limited regarding its safety and outcome in this age group. METHODS: Within the German Bariatric Surgery Registry, data from obese patients that underwent bariatric procedures in Germany are prospectively registered. The current analysis includes all adolescent and adult subjects that underwent primary Roux-Y-gastric bypass (RYGB) surgery from 2005 to 2014. RESULTS: Overall, 370 adolescents (≤ 21 years) and 16,840 obese adults were enrolled. In 2014, RYGB was the second most common bariatric procedure in Germany. In the adolescent group, initial BMI was higher (49.2 vs. 47.9 kg/m2, p < 0.01); the proportion of associated comorbidities was lower (67.8 vs. 87.4%, p < 0.01). Operation time (104.9 vs. 113.0 min, p < 0.01) and hospital stay (5.2 vs. 5.9 days; p < 0.01) differed significantly between both groups. The leakage rate in adults was 1.6%; none of the adolescents experienced a postoperative anastomotic leak (p = 0.04). No mortalities were reported in adolescents; the mortality rate in adults was 0.2%. The mean percentage of excess weight loss (% EWL) did not differ between both groups at 12 (69.9 vs. 68.2%; p = 0.97) and 24 months (72.6 vs. 72.1% p = 1.0). The remission rate for hypertension was higher in the adolescent group. CONCLUSION: RYGB can be performed in obese adolescents with lower morbidity and mortality. Despite all limitations of a multicentre registry and the low follow-up rate, the results show that weight change and resolution of comorbidities in the short term were at least comparable to those achieved in adults. The evaluation of safety and efficiency in the long run should now be in the focus of future studies.

Influence of Different Instrument Carrying Systems on the Kinematics of the Spine of Saxophonists.

AIMS: Back strain is a common musculoskeletal complaint affecting musicians, which may be related to unsuitable playing positions causing fatigue and muscle tension. In this study, three saxophone-carrying systems (neck-strap, shoulder-strap, and Saxholder) were examined for their effects on spinal column kinematics. METHODS: The influence of saxophone-carrying systems was investigated in 14 physically healthy alto saxophonists using ultrasound topometry. Additional tests were performed on 1 subject to examine the influence of the different weights of alto, tenor, and baritone saxophones with the three different carrying systems. RESULTS: The clearest difference between two systems (shoulder-strap vs Saxholder) was found in the angle at which the player's head bows forward while playing (3.35°; 95% CI 0.44, 6.26; p=0.0272). The use of the Saxholder resulted in a physiologically favorable axial position of the head. The head posture to ankle distance showed that the shoulder-strap and Saxholder, compared to the neck-strap, allowed a sagittal straightening and therefore advantageous axially balanced body position, although the differences were not statistically significant. The Saxholder also enabled a stabilization in the frontal section of the shoulders. In additional tests on 1 subject, the coefficient of variation showed that the instruments' weights had a larger influence on the physiologically favorable balanced body position than the different carrying systems. CONCLUSION: This pilot study was able to show that the technique of sonometric examination (Zebris) is an effective way to investigate the influence of instrument-carrying systems on the kinematics of the spine. The Saxholder may be physiologically advantageous, but further research with a larger sample is needed to verify the findings.

Axillary nerve lesions after open reduction and internal fixation of proximal humeral fractures through an extended lateral deltoid-split approach: electrophysiological findings.

BACKGROUND: Axillary nerve injuries after shoulder surgery are rare. In most studies, the frequency of injury is usually determined using clinical examinations, but results from intraoperative neuromonitoring studies have revealed higher than expected rates. Few studies have investigated this topic. Our aim was to determine the frequency of axillary nerve lesions after open reduction and internal fixation of proximal humeral fractures by using electrophysiological assessments and to provide a review of the relevant literature. METHODS: This was a retrospective cohort study of 76 consecutive patients who received open reduction and internal fixation of a proximal humeral fracture using a locking plate through a deltoid-splitting approach. We performed a clinical and electrophysiological examination at a minimum follow-up time of 12 months. Functional results were assessed according to the Constant-Murley and Disabilities of the Arm, Shoulder and Hand scores. Electrophysiological examinations comprised electromyography, electroneurography, and motor and somatosensory evoked potentials. The main outcome was the frequency of axillary nerve lesions. RESULTS: Forty patients were monitored for an average of 28 months. The mean raw Constant-Murley score was 61 points, the age- and gender-adjusted score was 71%, and the mean Disabilities of the Arm, Shoulder and Hand score was 33 points. Neurapraxia occurred in 1 patient, axonotmesis with incomplete reinnervation occurred in 3, and complete reinnervation occurred in 3. The latter group was classified as having a temporary axillary nerve lesion. CONCLUSIONS: The 10% rate of permanent axillary nerve lesions in our cohort is higher than expected based on the clinical examination. Electrophysiological assessment is therefore more appropriate to detect axillary nerve injuries.

Self-Gripping Meshes for Lichtenstein Repair. Do We Need Additional Suture Fixation?

BACKGROUND: The Lichtenstein repair is a frequently used treatment of inguinal hernias. In recent years, there has been an increasing tendency to apply self-gripping meshes (s.g). In many cases, additional suture of the mesh is carried out; however, it is uncertain what the benefits or potential risks of this actually are. METHODS: The evaluation was undertaken on the basis of the Herniamed register, and covered all unilateral Lichtenstein operations between 01.09.2009 up to 30.09.2013. The analysis only included patients with whom s.g. meshes with resorbable micro hooks had been used (Progrip(®), Covidien) and who had undergone a full 1-year follow-up examination (80.15 %). RESULTS: In total, 2095 patients were suitable for analysis, of which 816 (38.95 %) cases received an additional suture fixation (Fix). With increasing hernia size, more frequent fixation took place (29.97 % of hernias <1.5 cm vs. 46.65 % of hernias >3 cm, p < 0.001). The recurrence rates 1 year after surgery did not show any significant differences (Fix. 0.86 % vs. No Fix. 1.17 %; p = 0.661) with and without fixation, even when being adjusted for covariables. Likewise, no differences were noted in terms of postoperative complications (Fix. 5.15 % vs. No Fix. 5.08 %; p = 1.0). In addition, the numbers of patients needing to be treated after 1 year for chronic pain were also comparable (Fix. 2.33 % vs. No Fix. 2.97 %; p = 0.411). CONCLUSION: Within the group that did not have additional suture fixation of self-gripping meshes (No Fix.), the length of operations was on average 8 min shorter (p < 0.001). No differences could be observed in terms of postoperative complications, treatment requiring chronic pain and recurrence rates.