Efficacy and safety of bexagliflozin compared with dapagliflozin as an adjunct to metformin in Chinese patients with type 2 diabetes mellitus: A 24-week, randomized, double-blind, active-controlled, phase 3 trial.

BACKGROUND: Bexagliflozin and dapagliflozin are sodium-glucose cotransporter-2 (SGLT2) inhibitors. No direct comparison of SGLT2 inhibitors in a randomized controlled trial has been reported to date. METHODS: This was a multicenter, randomized, double-blind, active-controlled trial comparing bexagliflozin to dapagliflozin for the treatment of type 2 diabetes mellitus in adults with disease inadequately controlled by metformin. Subjects (n = 406) were randomized to receive bexagliflozin (20 mg) or dapagliflozin (10 mg) plus metformin. The primary endpoint was noninferiority of bexagliflozin to dapagliflozin for the change in glycated hemoglobin (HbA1c) from baseline to week 24. Secondary endpoints included intergroup differences in fasting plasma glucose (FPG), 2-h-postprandial glucose (PPG), body weight, and systolic blood pressure (SBP) from baseline to week 24. The trial also evaluated the safety profiles. RESULTS: The model-adjusted mean change from baseline to week 24 HbA1c was -1.08% for bexagliflozin and -1.10% for dapagliflozin. The intergroup difference of 0.03% (95% confidence interval [CI] -0.14% to 0.19%) was below the prespecified margin of 0.4%, confirming the noninferiority of bexagliflozin. The changes from baseline in FPG, PPG, body weight, and SBP were -1.95 mmol/L, -3.24 mmol/L, -2.52 kg, and -6.4 mm Hg in the bexagliflozin arm and -1.87 mmol/L, -3.07 mmol/L, -2.22 kg, and -6.3 mm Hg in the dapagliflozin arm. Adverse events were experienced in 62.6% and 65.0% and serious adverse events affected 4.4% and 3.5% of subjects in the bexagliflozin and dapagliflozin arm, respectively. CONCLUSIONS: Bexagliflozin showed nearly identical effects and a similar safety profile to dapagliflozin when used in Chinese patients on metformin.

Chronic postsurgical pain (CPSP): an underestimated problem after incisional hernia treatment.

BACKGROUND: Chronic postsurgical pain (CPSP) is a potential long-term problem following open incisional hernia repair which may affect the quality of life of patients despite successful anatomical repair of the hernia. The aim of this manuscript was to identify the incidence and outcome of patients following open incisional hernia repair in respect of risk factors to develop CPSP. METHODS: A single-center retrospective analysis of patients who underwent open incisional hernia repair between 2015 and 2021 was performed. Pre-existing conditions (e.g., diabetes mellitus and malignancy), hernia complexity, postoperative complications, and postoperative pain medication were analyzed using the local database. Quality of life and CPSP were assessed using the EuraHS Quality of Life (QoL) questionnaire. RESULTS: A total of 182 cases were retrospectively included in a detailed analysis based on the complete EuraHS (QoL) questionnaire. During the average follow-up period of 46 months, this long-term follow-up revealed a 54.4% incidence of CPSP and including a rate of 14.8% for severe CPSP (sCPSP) after open incisional hernia surgery. The complexity of the hernia and the demographic variables were not different between the group with and without CPSP. Patients with CPSP reported significantly reduced QoL. The analgesics score which includes the need of pain medication in the initial days after surgery was significantly higher in patients with CPSP than in those without (no CPSP: 2.86 vs. CPSP: 3.35; p = 0.047). CONCLUSION: The presence of CPSP after open incisional hernia repair represents a frequent and underestimated long-term problem which has been not been recognized to this extent before. CPSP impairs QoL in these patients. Patients at risk to develop CPSP can be identified in the perioperative setting by the need of high doses of pain medication using the analgesics score. Possibly timely adjustment of pain medication, even in the domestic setting, could alleviate the chronicity or severity of CPSP.

Meta-analysis of risk of major adverse cardiovascular events in adults with type 2 diabetes treated with bexagliflozin.

AIM: To explore the risk of major adverse cardiovascular events (MACE) associated with exposure to bexagliflozin. METHODS: The analysis included 4090 participants with type 2 diabetes (T2D) enrolled in nine phase 2 and 3 double-blind randomized controlled trials. All potential MACE were adjudicated by a blinded committee. The primary endpoint for the meta-analysis was the hazard ratio (HR) for the time to first occurrence of non-fatal stroke, non-fatal myocardial infarction (MI), cardiovascular (CV) death or hospitalization for unstable angina (MACE+), tested for non-inferiority to a ratio of 1.8. The secondary endpoints were time to first occurrence of (i) non-fatal stroke, non-fatal MI or CV death (MACE), tested for non-inferiority to a ratio of 1.3; and (ii) CV death or hospitalization for heart failure, tested for superiority. RESULTS: The HR for the primary endpoint of MACE+ was 0.80 (95% confidence interval [CI] 0.58, 1.09), which fulfilled the non-inferiority objective with a P value of less than 0.0001. Non-inferiority for the first key secondary endpoint of MACE was also shown (HR = 0.82; 95% CI 0.59, 1.13; P = 0.0023). Superiority for time to CV death or first hospitalization for heart failure was not shown. CONCLUSIONS: Bexagliflozin did not increase the risk of MACE in participants with T2D when compared with placebo or active control. Both the preapproval and postapproval thresholds for CV safety were met and bexagliflozin has been approved by the US Food and Drug Administration.

Postoperative Analgesics Score as a Predictor of Chronic Postoperative Inguinal Pain After Inguinal Hernia Repair: Lessons Learned From a Retrospective Analysis.

BACKGROUND: Chronic postoperative inguinal pain (CPIP) is a common complication after inguinal hernia surgery and occurs in up to 10-14% of cases. CPIP has a significant impact on daily life, work ability and thus compromises quality of life. The aim of this retrospective study was an in-depth analysis of patients undergoing inguinal hernia repair to further refine the prediction of the onset of CPIP reliably. METHODS: A single center retrospective analysis of patients with who underwent open or minimally invasive inguinal hernia repair from 2016 to 2021 was carried out. Complication rates, detailed analysis of postoperative pain medication and quality of life using the EuraHS Quality of Life questionnaire were assessed. RESULTS: Out of 596 consecutive procedures, 344 patients were included in detailed analyses. While patient cohorts were different in terms of age and co-morbidities, and the prevalence of CPIP was 12.2% without differences between the surgical procedures (Lichtenstein: 12.8%; TEP 10.9%; TAPP 13.5%). Postoperative pain was evaluated using a newly developed analgesic score. Patients who developed CPIP later had a significant higher consumption of analgesics at discharge (p = 0.016). As additional risk factors for CPIP younger patient age and postoperative complications were identified. CONCLUSION: The prospective use of the analgesic score established here could be helpful to identify patients that are at risk to develop CPIP. These patients could benefit from a structured follow-up to allow early therapeutic intervention to prevent chronification and restore the quality of life.

Optimizing laparoscopic training efficacy by 'deconstruction into key steps': a randomized controlled trial with novice medical students.

BACKGROUND: Simulator training is an effective way of acquiring laparoscopic skills but there remains a need to optimize teaching methods to accelerate learning. We evaluated the effect of the mental exercise 'deconstruction into key steps' (DIKS) on the time required to acquire laparoscopic skills. METHODS: A randomized controlled trial with undergraduate medical students was implemented into a structured curricular laparoscopic training course. The intervention group (IG) was trained using the DIKS approach, while the control group (CG) underwent the standard course. Laparoscopic performance of all participants was video-recorded at baseline (t0), after the first session (t1) and after the second session (t2) nine days later. Two double-blinded raters assessed the videos. The Impact of potential covariates on performance (gender, age, prior laparoscopic experience, self-assessed motivation and self-assessed dexterity) was evaluated with a self-report questionnaire. RESULTS: Both the IG (n = 58) and the CG (n = 68) improved their performance after each training session (p < 0.001) but with notable differences between sessions. Whereas the CG significantly improved their performance from t0 -t1 (p < 0.05), DIKS shortened practical exercise time by 58% so that the IG outperformed the CG from t1 -t2, (p < 0.05). High self-assessed motivation and dexterity associated with significantly better performance (p < 0.05). Male participants demonstrated significantly higher overall performance (p < 0.05). CONCLUSION: Mental exercises like DIKS can improve laparoscopic performance and shorten practice times. Given the limited exposure of surgical residents to simulator training, implementation of mental exercises like DIKS is highly recommended. Gender, self-assessed dexterity, and motivation all appreciably influence performance in laparoscopic training.

Improvement of functional outcome for patients with newly diagnosed grade 2 or 3 gliomas with co-deletion of 1p/19q - IMPROVE CODEL: the NOA-18 trial.

BACKGROUND: Given the young age of patients with CNS WHO grade 2 and 3 oligodendrogliomas and the relevant risk of neurocognitive, functional, and quality-of-life impairment with the current aggressive standard of care treatment, chemoradiation with PCV, of the tumour located in the brain optimizing care is the major challenge. METHODS: NOA-18 aims at improving qualified overall survival (qOS) for adult patients with CNS WHO grade 2 and 3 oligodendrogliomas by randomizing between standard chemoradiation with up to six six-weekly cycles with PCV and six six-weekly cycles with lomustine and temozolomide (CETEG) (n = 182 patients per group accrued over 4 years) thereby delaying radiotherapy and adding the chemoradiotherapy concept at progression after initial radiation-free chemotherapy, allowing for effective salvage treatment and delaying potentially deleterious side effects. QOS represents a new concept and is defined as OS without functional and/or cognitive and/or quality of life deterioration regardless of whether tumour progression or toxicity is the main cause. The primary objective is to show superiority of an initial CETEG treatment followed by partial brain radiotherapy (RT) plus PCV (RT-PCV) at progression over partial brain radiotherapy (RT) followed by procarbazine, lomustine, and vincristine (PCV) chemotherapy (RT-PCV) and best investigators choice (BIC) at progression for sustained qOS. An event concerning a sustained qOS is then defined as a functional and/or cognitive and/or quality of life deterioration after completion of primary therapy on two consecutive study visits with an interval of 3 months, tolerating a deviation of at most 1 month. Assessments are done with a 3-monthly MRI, assessment of the NANO scale, HRQoL, and KPS, and annual cognitive testing. Secondary objectives are evaluation and comparison of the two groups regarding secondary endpoints (short-term qOS, PFS, OS, complete and partial response rate). The trial is planned to be conducted at a minimum of 18 NOA study sites in Germany. DISCUSSION: qOS represents a new concept. The present NOA trial aims at showing the superiority of CETEG plus RT-PCV over RT-PCV plus BIC as determined at the level of OS without sustained functional deterioration for all patients with oligodendroglioma diagnosed according to the most recent WHO classification. TRIAL REGISTRATION: Clinicaltrials.gov NCT05331521 . EudraCT 2018-005027-16.

Factors influencing the fascial closure rate after open abdomen treatment: Results from the European Hernia Society (EuraHS) Registry : Surgical technique matters.

PURPOSE: Definitive fascial closure is an essential treatment objective after open abdomen treatment and mitigates morbidity and mortality. There is a paucity of evidence on factors that promote or prevent definitive fascial closure. METHODS: A multi-center multivariable analysis of data from the Open Abdomen Route of the European Hernia Society included all cases between 1 May 2015 and 31 December 2019. Different treatment elements, i.e. the use of a visceral protective layer, negative-pressure wound therapy and dynamic closure techniques, as well as patient characteristics were included in the multivariable analysis. The study was registered in the International Clinical Trials Registry Platform via the German Registry for Clinical Trials (DRK00021719). RESULTS: Data were included from 630 patients from eleven surgical departments in six European countries. Indications for OAT were peritonitis (46%), abdominal compartment syndrome (20.5%), burst abdomen (11.3%), abdominal trauma (9%), and other conditions (13.2%). The overall definitive fascial closure rate was 57.5% in the intention-to-treat analysis and 71% in the per-protocol analysis. The multivariable analysis showed a positive correlation of negative-pressure wound therapy (odds ratio: 2.496, p < 0.001) and dynamic closure techniques (odds ratio: 2.687, p < 0.001) with fascial closure and a negative correlation of intra-abdominal contamination (odds ratio: 0.630, p = 0.029) and the number of surgical procedures before OAT (odds ratio: 0.740, p = 0.005) with DFC. CONCLUSION: The clinical course and prognosis of open abdomen treatment can significantly be improved by the use of treatment elements such as negative-pressure wound therapy and dynamic closure techniques, which are associated with definitive fascial closure.

Markedly increased risk of postoperative bleeding complications during perioperative bridging anticoagulation in general and visceral surgery.

BACKGROUND: Increasing numbers of patients receiving oral anticoagulants are undergoing elective surgery. Low molecular weight heparin (LMWH) is frequently applied as bridging therapy during perioperative interruption of anticoagulation. The aim of this study was to explore the postoperative bleeding risk of patients receiving surgery under bridging anticoagulation. METHODS: We performed a monocentric retrospective two-arm matched cohort study. Patients that received perioperative bridging anticoagulation were compared to a matched control group with identical surgical procedure, age, and sex. Emergency and vascular operations were excluded. The primary endpoint was the incidence of major postoperative bleeding. Secondary endpoints were minor postoperative bleeding, thromboembolic events, length of stay, and in-hospital mortality. Multivariate analysis explored risk factors of major postoperative bleeding. RESULTS: A total of 263 patients in each study arm were analyzed. The patient cohort included the entire field of general and visceral surgery including a large proportion of major oncological resections. Bridging anticoagulation increased the postoperative incidence of major bleeding events (8% vs. 1%; p < 0.001) as well as minor bleeding events (14% vs. 5%; p < 0.001). Thromboembolic events were equally rare in both groups (1% vs. 2%; p = 0.45). No effect on mortality was observed (1.5% vs. 1.9%). Independent risk factors of major postoperative bleeding were full-therapeutic dose of LMWH, renal insufficiency, and the procedure-specific bleeding risk. CONCLUSION: Perioperative bridging anticoagulation, especially full-therapeutic dose LMWH, markedly increases the risk of postoperative bleeding complications in general and visceral surgery. Surgeons should carefully consider the practice of routine bridging.

[Recommendations for treatment of diverticular disease]. / Empfehlungen zur Therapie der Divertikelkrankheit.

BACKGROUND: Diverticular disease is of major clinical and health economic importance in Germany. Treatment recommendations in many international guidelines have changed significantly in recent years. The German national S2k guidelines are currently being revised. OBJECTIVE: To summarize the most important clinical aspects in the management of diverticular disease from a surgical perspective. MATERIAL AND METHODS: The recommendations were compiled based on current national and international guidelines and a selective literature search. RESULTS: Acute uncomplicated diverticulitis without risk factors can be treated on an outpatient basis without antibiotics. For patients with complicated diverticulitis, hospital admission with parenteral antibiotic treatment is recommended. In the case of abscess formation >5 cm, percutaneous drainage can be performed. The indications for immediate sigmoid resection are free perforation and failure of conservative treatment. Elective resection is indicated in chronic recurrent diverticulitis with complications; all other indications are increasingly based on the individual quality of life of the patient. CONCLUSION: Uncomplicated diverticulitis is increasingly being treated on an outpatient basis and without antibiotics. Apart from emergency settings, the indications for surgery are increasingly dependent on the quality of life. Elective sigmoid resection should be performed as laparoscopic surgery with primary anastomosis after obtaining results of computed tomography and total colonoscopy.

[Advanced training of general and visceral surgeons in life-saving emergency surgery : Results of a survey among participants of a surgery course]. / Fortbildung von Allgemein- und Viszeralchirurgen in der lebensrettenden Notfallchirurgie : Ergebnisse einer Umfrage unter Operationskursteilnehmern.

BACKGROUND: Due to a decreasing number of emergency procedures for body cavity injuries, surgical training is inadequate and current educational concepts must be reconsidered. The German Society for General and Visceral Surgery has set up a surgical training course in 2014 to overcome this shortage. In order to assess the eligibility, needs, benefits and success of such a training format, participants were asked to evaluate the program. MATERIAL AND METHODS: All participants evaluated the course during participation and were later asked to answer an online survey regarding their age, gender, level of surgical education, surgical discipline, level of care of the hospital, emergency surgical experience and frequency of performing emergency surgery, participation in other programs, experiences after participating in the course, rating of the current training curriculum and funding of such courses. RESULTS: Out of 142 participants 83 replied to the online survey. Over 90% reported a lasting positive influence of the course on emergency surgical skills. More than half of the responders remembered a clinical situation which they successfully managed due to the skills they gained during the course. Surgeons experienced in emergency treatment felt significantly more benefit than less experienced colleagues. A consultancy position, the level of care of the hospital, age and sex of the participants did not influence the overall benefits reported. The majority of responding surgeons were in favor of including such a training course in surgical education and stipulated public financial support. CONCLUSION: Course formats that mediate emergency surgery strategies and skills are established and well accepted. Training of surgeons in life-saving emergency surgery is in the public interest and is also partly the responsibility of society.

Neoadjuvant immunotherapy with combined ipilimumab and nivolumab in patients with melanoma with primary or in transit disease.

The introduction of new therapeutic agents has revolutionized the treatment of metastatic melanoma. The approval of adjuvant anti-programmed death-1 monotherapy with nivolumab or pembrolizumab, and dabrafenib plus trametinib has recently set a new landmark in the treatment of stage III melanoma. Now, clinical trials have shown that immune checkpoint blockade can be performed in a neoadjuvant setting, an approach established as a standard therapeutic approach for other tumour entities such as breast cancer. Recent studies suggest that a pathological response achieved by neoadjuvant immunotherapy is associated with long-term tumour control and that short neoadjuvant application of checkpoint inhibitors may be superior to adjuvant therapy. Most recently, neoadjuvant ipilimumab plus nivolumab in stage III melanoma was reported. With two courses of dose-optimized ipilimumab (1 mg kg-1 ) combined with nivolumab (3 mg kg-1 ), pathological responses were observed in 77% of patients, while only 20% of patients experienced grade 3 or 4 adverse events. However, the neoadjuvant trials employing combined immune checkpoint blockade conducted so far have excluded patients with in transit metastases, a common finding in stage III melanoma. Here we report four patients with in transit metastases or an advanced primary tumour who have been treated with neoadjuvant ipilimumab plus nivolumab according to the OpACIN-neo trial scheme (arm B). All patients achieved radiological disease control and a pathological response. None of the patients has relapsed so far. Linked Comment: Blankenstein and van Akkooi. Br J Dermatol 2020; 183:421-422.

Randomized clinical trial comparing liver resection with and without perioperative assessment of liver function.

BACKGROUND: Liver function tests may help to predict outcomes after liver surgery. The aim of this study was to evaluate the clinical impact on postoperative outcome and patient management of perioperative liver function testing using the LiMAx® test. METHODS: A multicentre RCT was conducted in six academic liver centres. Patients with intrahepatic tumours scheduled for open liver resection of at least one segment were eligible. Patients were randomized to undergo additional perioperative liver function tests (LiMAx® group) or standard care (control group). Patients in the intervention arm received two perioperative LiMAx® tests, one before the operation for surgical planning and another after surgery for postoperative management. The primary endpoint was the proportion of patients transferred directly to a general ward. Secondary endpoints were severe complications, length of hospital stay (LOS) and length of intermediate care/ICU (LOI) stay. RESULTS: Some 148 patients were randomized. Thirty-six of 58 patients (62 per cent) in the LiMAx® group were transferred directly to a general ward, compared with one of 60 (2 per cent) in the control group (P < 0·001). The rate of severe complications was significantly lower in the LiMAx® group (14 per cent versus 28 per cent in the control group; P = 0·022). LOS and LOI were significantly shorter in the LiMAx® group (LOS: 10·6 versus 13·3 days respectively, P = 0·012; LOI: 0·8 versus 3·0 days, P < 0·001). CONCLUSION: Perioperative use of the LiMAx® test improves postoperative management and reduces the incidence of severe complications after liver surgery. Registration number: NCT01785082 ( https://clinicaltrials.gov).

Engineering the Mucus Barrier.

Mucus selectively controls the transport of molecules, particulate matter, and microorganisms to the underlying epithelial layer. It may be desirable to weaken the mucus barrier to enable effective delivery of drug carriers. Alternatively, the mucus barrier can be strengthened to prevent epithelial interaction with pathogenic microbes or other exogenous materials. The dynamic mucus layer can undergo changes in structure (e.g., pore size) and/or composition (e.g., protein concentrations, mucin glycosylation) in response to stimuli that occur naturally or are purposely administered, thus altering its barrier function. This review outlines mechanisms by which mucus provides a selective barrier and methods to engineer the mucus layer from the perspective of strengthening or weakening its barrier properties. In addition, we discuss strategic design of drug carriers and dosing formulation properties for efficient delivery across the mucus barrier.

[Perioperative handling of anticoagulation]. / Perioperativer Umgang mit Antikoagulation.

A growing number of patients in Germany receive a long-term prophylactic anticoagulation with phenprocoumone or one of the novel direct oral anticoagulants (NOAC), such as dabigatran, rivaroxaban or apixaban. The most common indication for an oral anticoagulant therapy is atrial fibrillation (approximately 75%) where the anticoagulant therapy can reduce the risk for an embolic event, particularly stroke by 60%. Operations carried out during such a therapy can result in major bleeding complications. On the other hand, suspending anticoagulant therapy can lead to an increased risk of thromboembolisms. Thus, the preoperative assessment should address the bleeding risk of the planned operation, the individual risk of thromboembolism, as well as other factors, such as patient age and renal function. If the individual assessment shows a substantial risk of perioperative bleeding when anticoagulant treatment is continued and a substantial risk of thromboembolism if the treatment is suspended, then a perioperative bridging, for example with low molecular weight heparin, is necessary. Perioperative bridging also leads to an increased risk of perioperative bleeding. Thus, undifferentiated bridging for all patients with atrial fibrillation with anticoagulant treatment is not recommended. Instead, the indications for a perioperative bridging should be decided according to individual risk profiles.

[Perioperative handling of immunosuppressive therapy]. / Perioperativer Umgang mit immunsuppressiver Therapie.

Every year 16 million operations are performed in Germany. Many patients have an autoimmune disorder, for example rheumatoid arthritis, psoriasis or chronic inflammatory bowel disease, which requires treatment. Immunosuppressants are widely applied. Physicians must make a risk-adapted decision whether the immunosuppressant medication can be continued perioperatively or if certain drugs must be paused and if so, with what risks. The handling of immunosuppressants during the perioperative period is very relevant as many patients, for example with rheumatoid arthritis are in need of a hip or knee replacement or patients with inflammatory bowel disease need an operation due to the chronic illness. The interruption of an immunosuppressant therapy should be discussed in an interdisciplinary board according to the underlying disease, because the continuation of immunosuppressants perioperatively can lead to an increased rate of complications, especially wound healing disorders. If a patient is on a glucocorticoid therapy the following must be considered: during the perioperative period the body has an increased demand for glucocorticoids due to the stress reaction. If glucocorticoids are administered in a dosage of more than 7.5 mg/day equivalent of prednisolone this stress reaction is inhibited. Thus, in these cases a perioperative substitution with hydrocortisone is recommended.

[Perioperative handling of antidiabetic drugs]. / Perioperativer Umgang mit Antidiabetika.

Diabetes mellitus is the most frequent metabolic disorder in the western world with a prevalence of 3% in adults under 65 years of age and 14.3% in adults over 65 years of age. Due to the increasing age of our population, the number of patients taking oral antidiabetic drugs has increased. Thus, operating physicians must make a risk-adapted decision whether the medication can be continued perioperatively or if certain drugs must be paused, and if so, with what risks. Operative interventions can lead to a number of metabolic shifts, which change the normal glucose metabolism. Hyperglycemia in the perioperative period is a risk factor for postoperative sepsis, dysfunction of the endothelium, cerebral ischemia and poor wound healing. Due to perioperative fasting oral antidiabetic medication can lead to severe hypoglycemia if taken during this period. This leads to an increased morbidity and mortality in the perioperative period and extends the duration of stay in the intensive care unit (ICU) as well as the overall hospital stay. Oral antidiabetic medication should be paused on the day of the operation and restarted in line with the gradual postoperative return to solid food. Especially metformin, the most commonly used medication in the treatment of type 2 diabetes, should be paused perioperatively due to the severe side effect of lactate acidosis.

[The use of tumor therapeutics in the perioperative period]. / Perioperativer Umgang mit antitumoralen Medikamenten.

In 2010 Germany had 447,300 new cases of cancer. From 2000 to 2010 the incidence of cancer increased by 21% in men and by 14% in women. The change in the age structure with an aging population is the crucial influencing factor. Various cancer types can now be treated by oral antitumor agents used as a chronic medication. Physicians must decide whether the oral antitumor agents can be continued perioperatively or if certain drugs must be paused and if so, with what risks. Oral antitumor agents are a very heterogeneous group of medication. The use of oral antitumor agents during the perioperative period has not been thoroughly examined, but most often a perioperative interruption is recommended. In general, poor wound healing is a frequent complication of this group of medication. The handling of oral antitumor agents in the perioperative period should be based on an individual decision with consideration of the desired therapy goal as well as the individual prognosis. In general, all oral antitumor agents are chronic medication and are continued until a loss of efficacy or intolerable side effects occur. A potentially curative therapy should be paused for the shortest possible time in order not to jeopardize the remission already achieved. Furthermore, generally accepted recommendations concerning the interval between chemotherapy and a planned operation have not yet been established. A rough rule of thumb could be to plan the operation after the regeneration of the blood count or at the same point in time of the next planned chemotherapy.

[The use of platelet aggregation inhibitors in the perioperative period]. / Perioperativer Umgang mit Thrombozytenaggregationshemmern.

Every year 16 million operations are performed in Germany. Many patients take platelet aggregation inhibitors as a primary or secondary prevention to reduce the risk of cardiovascular events. Especially during the perioperative period, this risk reduction is relevant due to an increased risk for cardiac events (in approximately 6.2% of operations). As a result of a presumed increased risk of bleeding, platelet aggregation inhibitors are often paused perioperatively. Thus, doctors must decide on a risk-adapted basis whether the medication can be continued perioperatively and, if so, with what risks. If acetylsalicylic acid (ASA) treatment is solely used as primary prevention it can be paused during the perioperative period, whereas ASA treatment for secondary prevention should only be paused for operations within narrow confines. When pausing ASA, a sufficient time interval should be maintained before the operation. Furthermore, the ASA withdrawal syndrome with an increased predisposition for clotting is an important phenomenon to be considered. Additionally, the perioperative handling of dual platelet aggregation inhibition needed after coronary stent implantation should be addressed. Due to an increased risk for in-stent thrombosis, dual platelet aggregation inhibition is only reluctantly paused. Emergency surgery must, if not otherwise possible, be carried out even if the dual platelet aggregation inhibition is not paused; however, if the risk for intraoperative bleeding is too high and the risk of an in-stent thrombosis is lower in comparison, P2Y12 inhibitors (e.g. clopidogrel) should be paused and the operation carried out solely with ASA therapy.

Themes arising in clinical consultation for therapists implementing family-based treatment for adolescents with anorexia nervosa: a qualitative study.

BACKGROUND: Our study aims to explore and describe themes arising in sessions of clinical consultation with therapists implementing Family-Based Treatment (FBT) for adolescents with Anorexia Nervosa (AN). There is currently no literature describing the content of clinical consultation for FBT. Thus, this knowledge will add to the evidence-base on what therapists need from consultants in ongoing clinical consultation. METHODS: Eight therapists at four sites participated in this study, which spanned a two-year period. Following a two-day training workshop, each therapist treated at least one adolescent patient presenting with a restrictive eating disorder with FBT, focusing on adherence to the treatment manual. Clinical consultation sessions occurred monthly and were led by an external FBT expert. Thirty-five (average per site = 9) audio recorded group clinical consultation sessions were transcribed verbatim and coded for themes. Twenty percent of the transcripts were double-coded to ensure consistency. Fundamental qualitative description guided the sampling and data collection. RESULTS: Thematic content analysis revealed ten common themes relating to the provision of clinical consultation to therapists implementing FBT in clinical practice: encouraging parental meal time supervision,discussing the role of mothers, how to align parents, ensuring parental buy-in, when to transition to Phase 2, weighing the patient and the patients' knowledge of their weight, the role of siblings in FBT sessions, how best to manage patient co-morbidities, the role of the father in FBT and how best to manage the family meal. CONCLUSIONS: In conclusion, clinical consultation themes aligned with many of the central tenets of FBT, including how to help parents align their supportive approach during the refeeding process, and how to help parents assume control of eating disordered behaviours. This knowledge helps to guide consultants to anticipate common issues brought forward by therapists attempting to implement FBT.