Rates of Complications After Appendectomy in Children and Adolescents: Pediatric Surgical Compared to General Surgical Hospitals.

BACKGROUND: Appendectomies in children and adolescents are performed in Germany in pediatric surgical (PS) or general surgical hospitals (GS). The aim of this study is to evaluate whether the surgery in a PS or GS hospital has an influence on the postoperative course after appendectomy in children and adolescents. MATERIALS AND METHODS: Nationwide routine data from children and adolescents aged 1-17 y insured by the Local Health Insurance Fund who underwent appendectomy between 2014 and 2016 were analyzed (cohort study). Descriptive statistics were calculated both overall and in the two groups (PS and GS). Patients were additionally examined by age (1-5, 6-12, and 13-17 y), treatment (laparoscopic, open surgical, and conversion), and appendicitis type (nonacute: K36/K37/K38/R10, acute simple: K35.30/K35.8, and acute complex: K35.2/K35.31/K35.32). The influence of surgeon specialization on 90-d secondary surgery and 90-d general complications was assessed by multiple logistic regression. RESULTS: Altogether, 25,065 patients who underwent surgery in 83 PS and 906 GS hospitals were included. Logistic regression analysis revealed that PS was associated with a reduced risk of interventions in the 1-5- and 6-12-y age groups (odds ratio: 0.44, 0.62). Acute complex appendicitis, comorbidities, and open surgery significantly increased the risk for reintervention. PS was associated with an increased risk for complications in the 13-17-y age group (odds ratio: 1.66). CONCLUSIONS: PS and GS hospitals provided safe appendectomies in children and adolescents with low reintervention and complication rates. PS hospitals demonstrated advantages for patients in the 1-5- and 6-12-y age groups and GS hospitals for patients 13-17 y.

Influence of COVID-19 confinement measures on appendectomies in Germany-a claims data analysis of 9797 patients.

PURPOSE: COVID-19 pandemic had multiple influences on the social, industrial, and medical situation in all affected countries. Measures of obligatory medical confinement were suspensions of scheduled non-emergent surgical procedures and outpatients' clinics as well as overall access restrictions to hospitals and medical practices. The aim of this retrospective study was to assess if the obligatory confinement (lockdown) had an effect on the number of appendectomies (during and after the period of lockdown). METHODS: This retrospective study was based on anonymized nationwide administrative claims data of the German Local General Sickness Fund (AOK). Patients admitted for diseases of the appendix (ICD-10: K35-K38) or abdominal and pelvic pain (ICD-10: R10) who underwent an appendectomy (OPS: 5-470) were included. The study period included 6 weeks of German lockdown (16 March-26 April 2020) as well as 6 weeks before (03 February-15 March 2020) and after (27 April-07 June 2020). These periods were compared to the respective one in 2018 and 2019. RESULTS: The overall number of appendectomies was significantly reduced during the lockdown time in 2020 compared to that in 2018 and 2019. This decrease affects only appendectomies due to acute simple (ICD-10: K35.30, K35.8) and non-acute appendicitis (ICD-10: K36-K38, R10). Numbers for appendectomies in acute complex appendicitis remained unchanged. Female patients and in the age group 1-18 years showed the strongest decrease in number of cases. CONCLUSION: The lockdown in Germany resulted in a decreased number of appendectomies. This affected mainly appendectomies in simple acute and non-acute appendicitis, but not complicated acute appendicitis. The study gives no evidence that the confinement measures resulted in a deterioration of medical care for appendicitis.

Incidence and Grading of Complications After Gastrectomy for Cancer Using the GASTRODATA Registry: A European Retrospective Observational Study.

OBJECTIVE: Utilizing a standardized dataset based on a newly developed list of 27 univocally defined complications, this study analyzed data to assess the incidence and grading of complications and evaluate outcomes associated with gastrectomy for cancer in Europe. SUMMARY BACKGROUND DATA: The absence of a standardized system for recording gastrectomy-associated complications makes it difficult to compare results from different hospitals and countries. METHODS: Using a secure online platform (www.gastrodata.org), referral centers for gastric cancer in 11 European countries belonging to the Gastrectomy Complications Consensus Group recorded clinical, oncological, and surgical data, and outcome measures at hospital discharge and at 30 and 90 days postoperatively. This retrospective observational study included all consecutive resections over a 2-year period. RESULTS: A total of 1349 gastrectomies performed between January 2017 and December 2018 were entered into the database. Neoadjuvant chemotherapy was administered to 577 patients (42.8%). Total (46.1%) and subtotal (46.4%) gastrectomy were the predominant resections. D2 or D2+ lymphadenectomy was performed in almost 80% of operations. The overall complications' incidence was 29.8%; 402 patients developed 625 complications, with the most frequent being nonsurgical infections (23%), anastomotic leak (9.8%), other postoperative abnormal fluid from drainage and/or abdominal collections (9.3%), pleural effusion (8.3%), postoperative bleeding (5.6%), and other major complications requiring invasive treatment (5.6%). The median Clavien-Dindo score and Comprehensive Complications Index were IIIa and 26.2, respectively. In-hospital, 30-day, and 90-day mortality were 3.2%, 3.6%, and 4.5%, respectively. CONCLUSIONS: The use of a standardized platform to collect European data on perioperative complications revealed that gastrectomy for gastric cancer is still associated with heavy morbidity and mortality. Actions are needed to limit the incidence of, and to effectively treat, the most frequent and most lethal complications.

International consensus on a complications list after gastrectomy for cancer.

BACKGROUND: Perioperative complications can affect outcomes after gastrectomy for cancer, with high mortality and morbidity rates ranging between 10 and 40%. The absence of a standardized system for recording complications generates wide variation in evaluating their impacts on outcomes and hinders proposals of quality-improvement projects. The aim of this study was to provide a list of defined gastrectomy complications approved through international consensus. METHODS: The Gastrectomy Complications Consensus Group consists of 34 European gastric cancer experts who are members of the International Gastric Cancer Association. A group meeting established the work plan for study implementation through Delphi surveys. A consensus was reached regarding a set of standardized methods to define gastrectomy complications. RESULTS: A standardized list of 27 defined complications (grouped into 3 intraoperative, 14 postoperative general, and 10 postoperative surgical complications) was created to provide a simple but accurate template for recording individual gastrectomy complications. A consensus was reached for both the list of complications that should be considered major adverse events after gastrectomy for cancer and their specific definitions. The study group also agreed that an assessment of each surgical case should be completed at patient discharge and 90 days postoperatively using a Complication Recording Sheet. CONCLUSION: The list of defined complications (soon to be validated in an international multicenter study) and the ongoing development of an electronic datasheet app to record them provide the basic infrastructure to reach the ultimate goals of standardized international data collection, establishment of benchmark results, and fostering of quality-improvement projects.

[Quality Assurance Using Administrative/Routine Data for Cholelithiasis - Changes Over Time and Current Status]. / Qualitätssicherung mit Routinedaten bei Cholelithiasis ­ Veränderungen und aktueller Stand.

Quality assurance using administrative/routine data (QSR) is a relatively new measure to assess outcome quality. This approach is methodologically distinct from external quality assurance, as well as from quality assurance based upon registries. Since 2011, QSR for cholelithiasis within AOK patients has been overseen by the Scientific Institute of the AOK (WIdO). Following the introduction of an expert panel in 2013, numerous changes were put into place, whereby the indicator rates for transfusion/bleeding, various complications as well as the overall indicator were reduced. Interestingly, the risk adjusted quality differences between hospitals remained solid.

Follow-up after gastrectomy for cancer: the Charter Scaligero Consensus Conference.

PURPOSE: Presently, there is no scientific evidence supporting a definite role for follow-up after gastrectomy for cancer, and clinical practices are quite different around the globe. The aim of this consensus conference was to present an ideal prototype of follow-up after gastrectomy for cancer, based on shared experiences and taking into account the need to rationalize the diagnostic course without losing the possibility of detecting local recurrence at a potentially curable stage. METHODS: On June 19-22, 2013 in Verona (Italy), during the 10th International Gastric Cancer Congress (IGCC) of the International Gastric Cancer Association, a consensus meeting was held, concluding a 6-month, Web-based, consensus conference entitled "Rationale of oncological follow-up after gastrectomy for cancer." RESULTS: Forty-eight experts, with a geographical distribution reflecting different health cultures worldwide, participated in the consensus conference, and 39 attended the consensus meeting. Six statements were finally approved, displayed in a plenary session and signed by the vast majority of the 10th IGCC participants. These statements are attached as an annex to the Charter Scaligero on Gastric Cancer. CONCLUSION: After gastrectomy for cancer, oncological follow-up should be offered to patients; it should be tailored to the stage of the disease, mainly based on cross-sectional imaging, and should be discontinued after 5 years.

Third international conference of the European Union Network of Excellence on gastric and esophagogastric junction cancer, Cologne, Germany, June 2012.

In 2012 the European Union Network of Excellence on gastric and esophagogastric junction cancer (EUNE) held its third conference in Cologne, Germany. The main themes discussed included translational research, standard and audit, early diagnosis, development of surgical treatment, adequate surgery for EGJ cancer, adjuvant and neoadjuvant treatment, prevention of peritoneal carcinomatosis and finally education and training. The meeting was attended by 150 experts from 18 different countries.

International comparison of the German evidence-based S3-guidelines on the diagnosis and multimodal treatment of early and locally advanced gastric cancer, including adenocarcinoma of the lower esophagus.

BACKGROUND: Clinical guidelines are essential in implementing and maintaining nationwide stage-specific diagnostic and therapeutic standards. In 2011, the first German expert consensus guideline defined the evidence for diagnosis and treatment of early and locally advanced esophagogastric cancers. Here, we compare this guideline with other national guidelines as well as current literature. METHODS: The German S3-guideline used an approved development process with de novo literature research, international guideline adaptation, or good clinical practice. Other recent evidence-based national guidelines and current references were compared with German recommendations. RESULTS: In the German S3 and other Western guidelines, adenocarcinomas of the esophagogastric junction (AEG) are classified according to formerly defined AEG I-III subgroups due to the high surgical impact. To stage local disease, computed tomography of the chest and abdomen and endosonography are reinforced. In contrast, laparoscopy is optional for staging. Mucosal cancers (T1a) should be endoscopically resected "en-bloc" to allow complete histological evaluation of lateral and basal margins. For locally advanced cancers of the stomach or esophagogastric junction (≥T3N+), preferred treatment is preoperative and postoperative chemotherapy. Preoperative radiochemotherapy is an evidence-based alternative for large AEG type I-II tumors (≥T3N+). Additionally, some experts recommend treating T2 tumors with a similar approach, mainly because pretherapeutic staging is often considered to be unreliable. CONCLUSIONS: The German S3 guideline represents an up-to-date European position with regard to diagnosis, staging, and treatment recommendations for patients with locally advanced esophagogastric cancer. Effects of perioperative chemotherapy versus chemoradiotherapy are still to be investigated for adenocarcinoma of the cardia and the lower esophagus.

The Outcome of Laparoscopic Versus Open Appendectomy in Childhood.

BACKGROUND: Appendectomy in children is performed either lapa - roscopically (LA) or by open surgery (OA). We studied whether, and how, the outcome is affected by the technique used and by the intraoperative conversion of LA to OA. METHODS: We analyzed routine data from children and adolescents in three age groups (1-5 years, 6-12 years, and 13-17 years) who were insured by the AOK statutory health insurance carrier in Germany and who underwent appendectomy in the period 2017-2019. General surgical complications and reoperations within 90 days were assessed with relevant indicators. Associations between the surgical technique and these indicators were studied with logistic regression. RESULTS: Of the 21 541 patients included in the study, general surgical complications were observed in 2.1% and reoperations in 1.8% overall. Broken down by age group, the corresponding figures were 5.4% and 4.4% (age 1 to 5), 2.5% and 1.8% (age 6 to 12), and 1.5% and 1.6% (age 13 to 17). The main risk factors for complications and reoperations were acute complicated appendicitis and conversion from LA to OA. Regression analysis revealed similar outcomes with OA compared to LA in the 1-to-5 age group, (odds ratios and 95% confidence intervals: 1.1 [0.6; 2.1] for general surgical complications and 1.5 [0.8; 2.7] for reoperations), but worse outcomes with OA in the other two age groups (age 6 to 12: 1.9 [1.2; 2.9] and 2.1 [1.5; 2.9]; age 13 to 17: 1.7 [1.0; 2.9] and 2.2 [1.4; 3.6]). When conversions were assigned to the LA group, the odds ratio (OA compared to LA) for reoperation across all age groups was 3.5 [2.8; 4.4] in patients with acute uncomplicated appendicitis and 4.2 [3.4; 5.3] in patients with complicated appendicitis. Complicated appendicitis also increased the rate of general surgical complications and the length of stay in hospital. CONCLUSION: Among children in the two older age groups, LA was followed by fewer general surgical complications and reoperations than OA. These differences were less pronounced when conversions were counted as belonging to the LA group. Children aged 1-5 appear to benefit the least from the lapa - roscopic technique.

(Neo)-adjuvant chemo(-radio) therapy for adenocarcinomas of the gastroesophageal junction and the stomach in the West.

Worldwide, the treatment of adenocarcinomas of the gastroesophageal junction and stomach has changed over the past decades. It is no longer surgery alone. Nowadays, most patients undergo surgery plus pre- and/or postoperative therapies. However, there are still marked differences in surgical procedures between the East and the West which might influence the surgical prognosis and thereby also the choice of perioperative treatment strategies. In the East, with its more extended surgical procedures, including standard D2 dissections, the current treatment philosophy is primary surgery followed by adjuvant chemotherapy. Neoadjuvant approaches are restricted to really advanced tumors, and perioperative chemoradiation is not routinely used (at least to date). This clearly differs from treatment strategies currently recommended in Western countries. In Europe and North America, pre- plus postoperative chemotherapy has become the recommended treatment for locally more advanced tumors, and preoperative chemoradiation is increasingly administered to patients with adenocarcinomas of the gastroesophageal junction (Siewert type I/II). However, the role of postoperative chemotherapy (despite its increasing use) is still under discussion in the West (especially Europe) and not generally recommended/accepted as a standard treatment. Postoperative chemoradiation, which is one standard treatment in North America, is only regarded as a treatment option for patients after 'inadequate surgery' (i.e.

[Minimum case volume regulations in surgery from the perspective of the specialist society (DGCH) : Balancing act between science, politics, treatment reality and a range of other aspects]. / Mindestmengenregelungen in der Chirurgie aus Sicht der Fachgesellschaft (DGCH) : Spagat zwischen Wissenschaft, Politik, Versorgungsrealität und einer Reihe weiterer Aspekte.

The scientifically founded surgical specialist discussion regarding the legal requirements for minimum volume numbers for diverse organ systems and selected surgical procedures as the basis of quality assurance and optimization of treatment is not new. Comprehensive and also reliable data from national and international studies are available for colorectal surgery, pancreatic surgery, esophageal surgery, liver surgery and gastric surgery. Recently, the raising of the minimum volume for complex esophageal interventions by the Federal Joint Committee (G-BA) in Germany from 10 up to 26 procedures per hospital and year, reignited the debate on this topic as well as the debate on centralization in the healthcare system in general. This decision seems to be scientifically well-justified from the perspective of political bodies and realizable in the practical implementation; however, from the perspective of physicians routinely involved in the corresponding highly complex procedures, there is a very much broader basis for discussion, which is only partially covered by a report of the Institute for Quality and Efficiency in the Healthcare System (IQWiG) as the foundation of the decision of the G­BA. For the scientifically oriented surgical specialist society, in the first instance priority is given to the scientific evidence as the guiding principle. Nevertheless, aspects of the treatment reality cannot and should not be ignored. Therefore, the recommendations of the specialist society must be oriented not only to the quality of results but also to the realistic options for successful implementation in practice. Furthermore, questions of further education, the right of the patient to freedom of choice of the physician and preservation of the attractiveness of the occupational profile of surgeons are immanent topics for the surgical specialist society.

[Use of surgical simulators in further education-A nationwide analysis in Germany]. / Einsatz chirurgischer Simulatoren in der Weiterbildung ­ eine deutschlandweite Analyse.

BACKGROUND: In addition to learning theoretical knowledge, the medical specialist training in surgery necessitates the acquisition of practical surgical competences. Simulation-based teaching concepts represent an alternative to education and advanced training on patients. The aim of this study was to analyze the distribution and implementation of surgical simulators in German hospitals. METHODS: The data analysis was carried out based on an individual on-line questionnaire with a total of 19 standardized questions. This was sent to the senior surgeons in hospitals and clinics via the email distributors of specialist societies for surgery in Germany. RESULTS: A total of 267 complete datasets were analyzed (response rate 12%). Of the participants 84% reported that they were active in a teaching hospital. At the time of the investigation 143 surgical simulators were in use at 35% of the hospitals and clinics included in the evaluation. There were clear regional differences between the individual federal states. Of the participants, 21.1% did not have a simulator at the hospital but the acquisition of one was planned. Simulation training was most frequently used by students (41.1%) and physicians during further education (32.5%). Simulators were not integrated into advanced surgical training in 81.8%. Of the participating hospitals, 94% showed an interest in integration into surgical specialist training in the future. CONCLUSION: The results of this survey confirmed the special importance of simulation-based training for surgical education in German hospitals; however, at the same time there were clear deficits in information concerning user behavior and a deficiency in the perceived integration of simulation training in advanced training for surgery.

[Medicine and Economy: Measures for a Science Based, Patient-Centred and Resource Conscious Care. The Association of Scientific Medical Societies' (AWMF) Strategy Paper]. / Medizin und Ökonomie: Maßnahmen für eine wissenschaftlich begründete, patientenzentrierte und ressourcenbewusste Versorgung. Ein Strategiepapier der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF).

The AWMF and its medical societies perceive an increasing dominance of economic targets in the hospital health care sector, leading to impairment of patient care. While resource use in health care should be appropriate, efficient and fairly allocated, "economization" creates a burdensome situation for physicians, nurses and other health care professionals.The AMWF and the medical societies studied causes and developed measures for a scientific, patient-centred and resource-conscious medical care. Disincentives due to the remuneration system, number and equipment of hospitals resp. specialist departments and their basic funding need to be overcome. Proposed actions relate to the patient-doctor-level, the management level of hospitals and the level of planning and financing hospitals including compensation of hospital care. To place patients and their health in the forefront again, joint efforts of all stakeholders in health care are needed.

Perioperative chemotherapy with or without epidermal growth factor receptor blockade in unselected patients with locally advanced oesophagogastric adenocarcinoma: Randomized phase II study with advanced biomarker program of the German Cancer Society (AIO/CAO STO-0801).

BACKGROUND: Perioperative chemotherapy significantly improves survival in patients with locally advanced oesophagogastric cancer (EGC). However, as approximately 60% of patients will die from their disease, new therapeutic agents such as molecular-targeted drugs are needed. PATIENTS AND METHODS: To evaluate the role of panitumumab with perioperative chemotherapy, previously untreated patients with locally advanced EGC received, in an open-label randomised phase II study (NEOPECX), standard epirubicin, cisplatin, capecitabine (ECX) chemotherapy with or without panitumumab. The primary end-point was the histological response rate after neoadjuvant therapy. The expression status and gene copy number of EGFR, HER2, and MET were determined by immunohistochemistry and fluorescence in situ hybridization (FISH). Plasma samples were collected before the first cycle of neoadjuvant chemotherapy. RESULTS: Overall, 160 patients (80 versus 80) were eligible. The majority (82% versus 80%) showed lymph node involvement. Rate of R0-resection, percentage of patients with downstaging to ypT0-2 at pathohistological evaluation, and rate of major histological response was equal in both arms. Toxicity was increased by panitumumab with regard to thromboembolic events and skin toxicity. Patients with tumour EGFR, HER2 or MET expression had shorter progression-free and overall survival. FISH positivity for these markers was associated with shorter survival independent of therapy. High levels of soluble EGFR in particular predicted poor survival in the panitumumab arm. CONCLUSION: The addition of panitumumab to ECX did not improve downstaging of locally advanced EGC. Low plasma levels of pathway-associated proteins such as sEGFR may identify a group of patients that benefit from EGFR-directed therapy. CLINICALTRIALS.GOV: NCT01234324.

Gastric cancer treatment in the world: Germany.

Epidemiologically, around 15,500 persons per year contract gastric cancer with continuously decreasing incidence and a 5-year survival rate of only 30% to 35%. Contrary to the Asian countries, there are no prevention programs for gastric cancer in Germany, which leads to the disease frequently being diagnosed in locally advanced stages and predominantly being treated with multimodal therapy concepts. Complete (R0) resection is the therapy of choice for resectable gastric cancer. Special forms of gastric cancer that are limited to the mucosa can be endoscopically resected with a curative intent. Systematic D2 lymphadenectomy (LAD) plays a decisive role in the management of local advanced tumors because it significantly contributes to the reduction of tumor-related death and both local and regional relapse rates. Perioperative chemotherapy improves prognosis in the advanced stages, whereas palliative chemotherapy is normally indicated for metastatic diseases. Standardized resection procedures and the use of individualized multimodal therapy concepts have led to improvement in the 5-year survival rate.

Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus.

PURPOSE: Combined chemoradiotherapy with and without surgery are widely accepted alternatives for the curative treatment of patients with locally advanced esophageal cancer. The value of adding surgery to chemotherapy and radiotherapy is unknown. PATIENTS AND METHODS: Patients with locally advanced squamous cell carcinoma (SCC) of the esophagus were randomly allocated to either induction chemotherapy followed by chemoradiotherapy (40 Gy) followed by surgery (arm A), or the same induction chemotherapy followed by chemoradiotherapy (at least 65 Gy) without surgery (arm B). Primary outcome was overall survival time. RESULTS: The median observation time was 6 years. The analysis of 172 eligible, randomized patients (86 patients per arm) showed overall survival to be equivalent between the two treatment groups (log-rank test for equivalence, P < .05). Local progression-free survival was better in the surgery group (2-year progression-free survival, 64.3%; 95% CI, 52.1% to 76.5%) than in the chemoradiotherapy group (2-year progression-free survival, 40.7%; 95% CI, 28.9% to 52.5%; hazard ratio [HR] for arm B v arm A, 2.1; 95% CI, 1.3 to 3.5; P = .003). Treatment-related mortality was significantly increased in the surgery group than in the chemoradiotherapy group (12.8% v 3.5%, respectively; P = .03). Cox regression analysis revealed clinical tumor response to induction chemotherapy to be the single independent prognostic factor for overall survival (HR, 0.30; 95% CI, 0.19 to 0.47; P < .0001). CONCLUSION: Adding surgery to chemoradiotherapy improves local tumor control but does not increase survival of patients with locally advanced esophageal SCC. Tumor response to induction chemotherapy identifies a favorable prognostic group within these high-risk patients, regardless of the treatment group.