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1.
Ann Surg ; 2019 Nov 27.
Artículo en Inglés | MEDLINE | ID: mdl-31800490

RESUMEN

OBJECTIVES: PORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation. BACKGROUND DATA: The implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear. METHODS: PORTAS-3 was a multicentre, randomized, controlled, parallel-group superiority trial. Adult patients with oncological disease scheduled for elective port implantation were randomized to a primary open or closed strategy. Primary endpoint was the rate of pneumothorax or haemothorax. Assuming a difference of 2.5% between the 2 groups, a sample size of 1154 patients was needed to prove superiority of the open group. A logistic regression model after the intention-to-treat principle was applied for analysis of the primary endpoint. RESULTS: Between November 9, 2014 and September 5, 2016, 1205 patients were randomized. Of these, 1159 (open n = 583; closed n = 576) were finally analyzed. The rate of pneumothorax or haemothorax was significantly reduced with the open strategy [odds ratio 0.27, 95% confidence interval (CI) 0.09-0.88; P = 0.029]. Operation time was shorter for the closed strategy. Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups. CONCLUSION: A primary open strategy by cut-down of the cephalic vein, if necessary enhanced by a modified Seldinger technique, reduces the frequency of pneumothorax or haemothorax after central venous port implantation significantly compared with a closed strategy by primary puncture of the subclavian vein without routine sonographic guidance. Therefore, open surgical cut-down should be the reference standard for port implantation in comparable cohorts. TRIAL REGISTRATION: German Clinical Trials Register DRKS 00004900.

2.
Zentralbl Chir ; 2019 Oct 28.
Artículo en Alemán | MEDLINE | ID: mdl-31658485

RESUMEN

BACKGROUND: Scientific skills are not sufficiently taught during medical training, neither in medical school nor during postgraduate education. This results in a lack of clinician scientists. In order to counter this problem, the surgical study network (CHIR-Net) founded SIGMA (Student-initiated German Medical Audit). This paper describes the development, performance and evaluation of a Clinical Investigator Training (CIT) aiming to qualify students to autonomously conduct clinical trials. MATERIAL AND METHODS: Based on the Kern cycle, a curriculum was developed, composed of three parts: online tutorials, a workshop and a follow-up period. The educational objectives were defined according to Bloom's taxonomy of knowledge. The learning objectives were based on the requirements of the "Network of Coordinating Centers for Clinical Trials" and the German Medical Association as well as content relevant to clinical studies. A wide range of educational instruments and assessments were used. By including all relevant professional groups involved in clinical trials, an interconnected working environment for students was generated. The increase in knowledge was assessed by a multiple-choice pre/post exam. The satisfaction of participants was analysed by a 5-point Likert scale, on which 5 indicated full approval. RESULTS: The first SIGMA CIT was realised in 2018; the workshop took place in Heidelberg in February. Thirty-two medical students from thirteen different centres participated. On average, 53.8 ± 8.3% of questions were answered correctly in the pre-test, compared with 71.2 ± 7.2% in the post-test (p < 0.0001). The maximal individual improvement was 30%; the lowest difference compared to the pre-test was 5%. Subjective evaluation results were positive with an average result of 4.63 ± 0.34 on a 5-point Likert scale. CONCLUSION: It is feasible to teach medical students the fundamentals of clinical trials. A compact Clinical Investigator Training using modern principles of teaching is able to prepare students for an autonomous performance of clinical trials.

3.
BMJ Open ; 9(9): e032353, 2019 09 30.
Artículo en Inglés | MEDLINE | ID: mdl-31575583

RESUMEN

INTRODUCTION: Pancreatic surgery is a large and complex field of research. Several evidence gaps exist for specific diseases or surgical procedures. An overview on existing knowledge is needed to plan and prioritise future research. The aim of this project is to create a systematic and living evidence map of pancreatic surgery. METHODS AND ANALYSIS: A systematic literature search in MEDLINE (via PubMed), Web of Science and Cochrane Central Register of Controlled Trials will be performed searching for all randomised controlled trials (RCT) and systematic reviews (SR) on pancreatic surgery. RCT and SR will be grouped in research topics. Baseline and outcome data from RCT will be extracted, presented and effect sizes meta-analysed. Data from SR will be used to identify evidence gaps. A freely accessible web-based evidence map in the format of a mind map will be created. The evidence map and meta-analyses will be updated periodically. DISSEMINATION: After completion of the project, a permanently updated evidence map of pancreatic surgery will be available to patients, physicians, researchers and funding bodies via www.evidencemap.surgery. Its use will allow clinical decision-making based on primary data and prioritisation of future research endeavours. PROSPERO REGISTRATION NUMBER: CRD42019133444.

4.
J Gastrointest Surg ; 2019 Jul 19.
Artículo en Inglés | MEDLINE | ID: mdl-31325140

RESUMEN

BACKGROUND: The benefit of preoperative biliary stenting in the treatment of pancreatic ductal adenocarcinoma is controversially debated. Data from recent meta-analyses favor primary surgery for the majority of resectable pancreatic cancers. Regardless of this evidence, preoperative biliary stenting via endoscopy (EBS) is commonly performed, often before involvement of a surgeon. The goal of this study was to elucidate the association of bile duct stenting, microbiological dislocation of gut flora to the biliary compartment, and major postoperative complications. METHODS: Patient data was derived from a prospectively maintained database including all pancreatic resections between January 2006 and December 2014. Patients receiving pancreaticoduodenectomy for malignant disease in the head of the pancreas with prior EBS were included. Microbiological data were obtained through conventional culture from intraoperative bile duct swabs. RESULTS: Two hundred ninety-eight patients were enrolled in this study. Severe postoperative complications were associated with stent colonization: Postoperative pancreatic fistula type C occurred more frequently in E. coli-colonized patients (sample estimated odds ratio (OR) = 4.07), and the rate of lymphatic fistula was elevated in Enterococcus-colonized patients (OR = 3.25). Longer stenting duration (> 16 days) was associated with the prevalence of these bacteria. CONCLUSION: Major surgical complications following pancreaticoduodenectomy, including severe pancreatic fistula, are associated with bacterobilia after EBS. The indication for bile duct stenting should be evaluated in a multidisciplinary setting.

5.
Trials ; 20(1): 332, 2019 Jun 07.
Artículo en Inglés | MEDLINE | ID: mdl-31174583

RESUMEN

BACKGROUND: The placement of prophylactic intra-abdominal drains has been common practice in abdominal operations including pancreatic surgery. The PANDRA trial showed that the omission of drains following pancreatic head resection was non-inferior to intra-abdominal drainage in terms of postoperative reinterventions and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. The aim of the present PANDRA II trial is to evaluate the clinical outcome with versus without prophylactic drain placement after distal pancreatectomy. METHODS: The PANDRA II trial is a mono-center, randomized controlled, non-inferiority trial with two parallel study groups. In the control group at least one passive intra-abdominal drain is placed at the pancreatic resection margin. In the experimental group no drains are placed. The primary endpoint of this trial will be the Comprehensive Complication Index (CCI) measuring all postoperative complications within 90 days. Secondary endpoints are in-hospital mortality and morbidity, including the rates of postoperative pancreatic fistula, chyle leak, postpancreatectomy hemorrhage, delayed gastric emptying, reinterventions and reoperations, surgical site infection, and abdominal fascia dehiscence. Moreover, length of hospital stay, duration of intensive care unit stay, and the rate of readmission after discharge from hospital (up to day 90 after surgery) are assessed. We will need to analyze 252 patients to test the hypothesis that no drainage is non-inferior to drain placement in terms of the CCI (δ 7.5 points) in a one-sided t test with a one-sided level of significance of 2.5% and a power of 80%. DISCUSSION: The results of the PANDRA II trial will help to evaluate the effect of an omission of prophylactic intraperitoneal drainage on the rate of complications after open or minimally invasive distal pancreatectomy. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00013763 . Registered on 6 March 2018.

6.
J Gastrointest Surg ; 2019 Jun 21.
Artículo en Inglés | MEDLINE | ID: mdl-31228083

RESUMEN

BACKGROUND: Physical exercise prehabilitation has been proposed to improve postoperative outcomes in patients undergoing major abdominal surgery. The aim of this systematic review was to investigate the effect of preoperative exercise training compared with standard care on postoperative outcomes in major abdominal surgery. METHODS: Randomized controlled trials (RCT) comparing prehabilitation with standard care were identified by a systematic literature search of MEDLINE and CENTRAL. Qualitative and quantitative analyses of perioperative outcome data were conducted. Meta-analyses were performed wherever possible and meaningful. RESULTS: A total of eight trials including 442 patients met the inclusion criteria. These trials investigated the effect of prehabilitation in patient cohorts undergoing major liver, colorectal, gastroesophageal, and general abdominal surgery. Quantitative analyses of all included trials showed a significant reduction in postoperative pulmonary complications (OR 0.37; 0.20 to 0.67; p = 0.001) as well as in postoperative overall morbidity (OR 0.52; 0.30 to 0.88; p = 0.01) in the prehabilitation group compared with standard care. The length of hospital stay showed no significant differences between the groups (MD - 0.58; - 1.28 to 0.13; p = 0.11). Risk of bias and methodological quality varied substantially among the trials, most of which were small single-center studies. CONCLUSION: Prehabilitation including a physical exercise intervention may lead to a reduction of postoperative pulmonary complications as well as less overall morbidity compared with standard care in patients undergoing major abdominal surgery. Further, well-designed RCT are needed to evaluate these potential positive effects in more detail and to identify suitable target populations. PROTOCOL REGISTRATION: PROSPERO 2017 CRD42017080366.

7.
Eur J Surg Oncol ; 45(8): 1453-1459, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-30981446

RESUMEN

BACKGROUND: Effective chemotherapy protocols are currently changing the treatment options for metastasized pancreatic cancer. Survival benefits after synchronous metastasectomy have been reported for selected patients. We set out to assess predictive factors of resectability for synchronous metastases after FOLFIRINOX. METHODS: Consecutive patients with metastatic pancreatic cancer undergoing surgery after FOLFIRINOX between 2011 and 2017 were identified from a prospectively collected database. Surgery following chemotherapy was indicated in patients with no more than six metastatic lesions, no progression detected on CT, and technically resectable disease. Patients who received synchronous metastasectomy were compared with patients who received explorative laparotomy or palliative surgery in terms of predictors of resectability and overall survival. In patients undergoing resection, prognostic factors were examined. RESULTS: Of 101 patients scheduled for surgery after FOLFIRINOX, synchronous metastasectomy was performed in 43 cases (43%) and non-resection surgery in 58 cases (57%). The shrinkage rate of the primary tumor on CT (P = 0.04) and the postchemotherapy serum CA19-9 concentration (P = 0.02) were associated with resectability. The median overall survival of the patients undergoing metastasectomy was longer than that of the patients without resection (21.9 months vs 16.4 months, P = 0.006). Postchemotherapy serum CA19-9 value (P = 0.04) and lymph node ratio (P = 0.01) were prognostic factors in the patients undergoing metastasectomy. CONCLUSIONS: In selected patients who satisfied our surgical criteria, shrinkage rate of primary tumor and postchemotherapy serum CA19-9 level, which predict resectability of metastasized pancreatic cancer, should be considered in decision making to avoid unnecessary surgery.

8.
Langenbecks Arch Surg ; 404(3): 273-284, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-30824993

RESUMEN

RATIONALE: Blinding reduces performance and detection bias in randomized controlled trials (RCT). There is evidence that lack of blinding leads to overestimation of treatment effects in pharmacological trials. Since surgical trials use interventions with a physical component, blinding is often complicated. The aim of this study was to analyze, in general and abdominal surgery RCT, the status of blinding, the potential for blinding, and the influence of blinding on outcomes. METHODS: A systematic search of the literature in CENTRAL, MEDLINE, and Web of Science was conducted to identify RCT with a surgical intervention, starting in 1996, the year when the first CONSORT statement was published. Information on general study characteristics and blinding methods was extracted. The presence or absence of blinding of the study contributors-patients, surgeons, data collectors, outcome assessors, and data analysts-was analyzed. The association of blinding with the trial outcome was investigated for every study contributor. RESULTS: Out of 29,119 articles, 378 RCT were included in the analysis. These investigated a total of 62,522 patients, of whom 15,025 were blinded (24.0%). Contributors could have been blinded in far more trials, as the potential for blinding measures ranged from 69% for outcome assessors to 98% for data analysts. If blinding of surgeons would have been possible but had not been performed, this was associated with more significant trial outcomes (OR 13.670; 95% CI 1.308 to 142.840; p = 0.0289). DISCUSSION: The potential of blinding, an important quality measure in surgical RCT, has not been exhausted. This study summarizes the existing evidence on blinding in surgical trials and gives evidence-based recommendations for the use of blinding in future surgical trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2015:CRD42015026837.

9.
Ann Surg ; 2019 Mar 20.
Artículo en Inglés | MEDLINE | ID: mdl-30921051

RESUMEN

MINI: We analyzed prognostic factors after neoadjuvant therapy and resection in 280 patients with initially unresectable pancreatic cancer-the largest single-center study reported. We found that preoperative CA 19-9 levels, lymph node status, presence of distant metastases, and vascular involvement were all independent overall survival predictors, but not resection margin status. OBJECTIVE: To evaluate the impact of clinical and pathological parameters, including resection margin (R) status, on survival in patients undergoing pancreatic surgery after neoadjuvant treatment for initially unresectable pancreatic ductal adenocarcinoma (PDAC). BACKGROUND: Prognostic factors are well documented for patients with resectable PDAC, but have not been described in detail for patients with initially unresectable PDAC undergoing resection after neoadjuvant therapy. METHODS: Prospectively collected data of consecutive patients with initially unresectable pancreatic cancer treated by neoadjuvant treatment and resection were analyzed. The R status was categorized as R0 (tumor-free margin >1 mm), R1 ≤1 mm (tumor-free margin ≤1 mm), and R1 direct (microscopic tumor infiltration at margin). Clinicopathological characteristics and outcomes were compared among these groups and tested for survival prediction. RESULTS: Between January, 2006 and February, 2017, 280 patients with borderline resectable (n = 18), locally advanced (n = 190), or oligometastatic (n = 72) disease underwent tumor resection after neoadjuvant treatment. Median overall survival from the time of surgery was 25.1 months for R0 (n = 82), 15.3 months for R1 ≤1 mm (n = 99), and 16.1 months for R1 direct (n = 99), with 3-year overall survival rates of 35.0%, 20.7%, and 18.5%, respectively (P = 0.0076). The median duration of the neoadjuvant treatment period was 5.1 months. In multivariable analysis, preoperative CA 19-9 levels, lymph node status, metastasis category, and vascular involvement were all significant prognostic factors for overall survival. The R status was not an independent prognostic factor. CONCLUSIONS: In patients undergoing resection after neoadjuvant therapy for initially unresectable PDAC, preoperative CA 19-9 levels, lymph node involvement, metastasis category, and vascular involvement, but not the R status, were independent prognostic factors of overall survival.

10.
BMC Med Educ ; 19(1): 48, 2019 Feb 07.
Artículo en Inglés | MEDLINE | ID: mdl-30732614

RESUMEN

BACKGROUND: To meet the patients' needs and to provide adequate health care, students need to be prepared for interprofessional collaborative practice during their undergraduate education. On interprofessional training wards (IPTW) undergraduates of various health care professions potentially develop a mutual understanding and improve their interprofessional competencies in clinical practice. To enhance collaboration of 6th-year medical students and nursing trainees in the third year of their vocational training an IPTW (Heidelberger Interprofessionelle Ausbildungsstation - HIPSTA) was implemented at the University Hospital Heidelberg, Germany. On HIPSTA future physicians and nurses take care of the patients self responsibly and in close interprofessional collaboration, supervised by facilitators of both professions. Although there are positive experiences with IPTWs internationally, little is known about the impact of IPTW on the acquisition of interprofessional competencies. For future interprofessional training and implementation of IPTWs evaluation of interprofessional learning and collaborative practice on Germany's first IPTW is of high relevance. METHODS: To evaluate the acquisition of interprofessional competencies the study follows a mixed-methods approach. Quantitative data is collected from undergraduate participants, staff participants and facilitators on HIPSTA (intervention group) and undergraduate participants and staff participants on a comparable 'conventional' ward without special interprofessional training (comparison group) immediately pre and post HIPSTA and, as follow-up, after three to six months (T0, T1, T2), using three questionnaires, namely the University of the West of England Interprofessional Questionnaire (UWE-IP), the Interprofessional Socialization and Valuing Scale (ISVS) and the Assessment of Interprofessional Team Collaboration Scale (AITCS). Qualitative data is gathered in form of interviews and focus groups based on semi structured guidelines, video recordings of handovers and overt non-participant observations of daily rounds. Quantitative data will be analysed in a longitudinal comparison, presented descriptively and tested with an analysis of variance. Qualitative data will be analysed deductively and inductively. DISCUSSION: The results of the evaluation will give insight in undergraduates', staff's and facilitators' experiences and their self-perception of competency development. In addition the results will help identify benefits, challenges and areas for modification when implementing and establishing similar interprofessional training wards.


Asunto(s)
Competencia Clínica/normas , Educación de Pregrado en Medicina , Relaciones Interprofesionales , Estudiantes de Medicina , Adulto , Actitud del Personal de Salud , Educación de Pregrado en Medicina/normas , Femenino , Alemania , Humanos , Comunicación Interdisciplinaria , Estudios Longitudinales , Masculino , Grupo de Atención al Paciente , Aprendizaje Basado en Problemas , Evaluación de Programas y Proyectos de Salud , Estudios Prospectivos , Investigación Cualitativa , Estudiantes de Medicina/psicología
11.
Langenbecks Arch Surg ; 404(1): 103-113, 2019 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-30607534

RESUMEN

PURPOSE: The aim of this systematic review and meta-analysis was to compare the oncological and perioperative outcomes of transhiatally extended gastrectomy (TEG) and thoracoabdominal esophagectomy (TAE) for therapy of adenocarcinomas of the esophagogastric junction (AEG) with focus on AEG type II, as the optimal approach for these tumors is still unclear. METHODS: MEDLINE, EMBASE, and the Cochrane Library (CENTRAL) were searched until July 24, 2018. Studies comparing TAE and TEG for surgical treatment of AEG type tumors have been included. Patient's baseline and perioperative data have been extracted and meta-analyses have been conducted for the outcomes: number of dissected lymph nodes, R0-resection rate, anastomotic leak rate, postoperative morbidity, and 30-day mortality. RESULTS: Of 6709 articles identified, 8 studies have been included for further analysis. One thousand thirty-four patients underwent TAE, and 1177 patients TEG. No differences were found between the approaches in regard to number of dissected lymph nodes (MD - 0.96; 95% CI - 3.07 to 1.15; p = 0.37), R0-resection rates (OR 0.97; 95% CI 0.57 to 1.63; p = 0.90), anastomotic leak rates (OR 1.13; 95% CI 0.69 to 1.86; p = 0.63), and 30-day mortality (OR 1.53; 95% CI 0.90 to 2.61; p = 0.11). However, a higher rate of postoperative morbidity was found after TAE (OR 1.55; 95% CI 1.12 to 2.14; p = 0.008). CONCLUSIONS: The optimal approach to surgical therapy of AEG II still remains unclear. This study identified a significantly higher rate of postoperative morbidity after TAE at comparable surgical outcomes. Due to major limitations concerning the quality of included studies, current data strongly mandates a properly designed randomized controlled trial to identify the optimal surgical approach for AEG type II tumors.


Asunto(s)
Adenocarcinoma/cirugía , Neoplasias Esofágicas/cirugía , Esofagectomía/métodos , Unión Esofagogástrica , Gastrectomía/métodos , Complicaciones Posoperatorias/epidemiología , Adenocarcinoma/mortalidad , Adenocarcinoma/patología , Neoplasias Esofágicas/mortalidad , Neoplasias Esofágicas/patología , Esofagectomía/efectos adversos , Gastrectomía/efectos adversos , Humanos
12.
J Gastrointest Surg ; 2019 Jan 22.
Artículo en Inglés | MEDLINE | ID: mdl-30671796

RESUMEN

BACKGROUND: The randomized controlled PROPP trial (DKRS00004191) showed that pylorus-resecting pancreatoduodenectomy (PR) is not superior to the pylorus-preserving procedure (PP) in terms of perioperative outcome, specifically in reduction of delayed gastric emptying. Non-superiority of PR was also confirmed in a recent meta-analysis of randomized controlled trials. However, long-term data on morbidity and quality of life after PP compared to PR are sparse. The aim of this study was to investigate long-term outcomes of patients included in the PROPP trial. METHODS: Between February 2013 and June 2016, a total of 188 patients underwent PD and were intraoperatively randomized to either preservation or resection of the pylorus (95 vs. 93 patients). For long-term follow-up, morbidity and quality of life (EORTC QLQ-C30/PAN26) were monitored until January 1, 2018. Statistical analysis was performed on an intention-to-treat basis. RESULTS: The mean duration of follow-up was 34.3 (± 11.3) months. Sixty-three of the 188 patients had died (PP n = 33, PR n = 30), 29 patients were lost to follow-up (PP n = 17, PR n = 12), and the remaining 96 patients were included in long-term follow-up (PP n = 45, PR n = 51). There was no difference between PP and PR patients regarding endocrine and exocrine pancreatic function, receipt of adjuvant/palliative chemotherapy, cancer recurrence, and other relevant characteristics. Late cholangitis occurred significantly more often in patients following pylorus resection (P = 0.042). Reoperations, readmissions to hospital, and quality of life scores except pain were comparable between the two study groups. CONCLUSIONS: Similar to short-term results, long-term follow-up showed no significant differences between pylorus resection compared to pylorus preservation.

13.
BMC Surg ; 18(1): 90, 2018 Oct 29.
Artículo en Inglés | MEDLINE | ID: mdl-30373596

RESUMEN

BACKGROUND: One of the most important aspects of designing a clinical trial is selecting appropriate outcomes. Patient-reported outcomes (PROs) can provide a personal assessment of the burden and impact of a malignant disease and its treatment. PROs comprise a wide range of outcomes including basic clinical symptom scores and complex metrics such as health-related quality of life (HRQoL). There is limited data on how postoperative complications following cancer surgery affect symptoms and HRQoL. For this reason the primary aim of the PATRONUS study is to investigate how perioperative complications affect cancer-related symptoms and HRQoL in patients undergoing abdominal cancer surgery. The PATRONUS study is designed and will be initiated and conducted by medical students under the direct supervision of clinician scientists based on the concept of inquiry-based learning. METHODS: PATRONUS is a non-interventional prospective multicentre cohort study. Patients undergoing elective oncological abdominal surgery will be recruited at regional centres of the clinical network of the German Surgical Society (CHIR-Net) and associated hospitals. A core set of 12 cancer associated symptoms will be assessed via the PRO version of the Common Terminology Criteria for Adverse Events. The cancer-specific HRQoL will be measured via the computerised adaptive testing version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. PROs will be measured eight times over a period of six months. The short-term clinical outcome measure is the rate of postoperative complications (grade II to V) within 30 days according to the Clavien-Dindo classification. The long-term clinical outcome is overall survival within six months postoperative. DISCUSSION: PATRONUS will provide essential insights into the patients' assessment of their well-being and quality of life in direct relation to clinical outcome parameters following abdominal cancer surgery. Furthermore, PATRONUS will investigate the feasibility of multicentre student-led clinical research. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00013035 (registered on October 26, 2017). Universal Trial Number (UTN): U1111-1202-8863.

14.
GMS J Med Educ ; 35(3): Doc33, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30186943

RESUMEN

Background: Deficits in care and impaired patient-safety have been linked to inefficient interprofessional collaborative practice. Interprofessional training wards (IPTW) are an interprofessional educational intervention which aim to enable students and trainees from different health professions to work self-responsibly in order to manage the medical treatment and rehabilitation of real-life patients together as an interprofessional team. We aimed to develop and implement Germany´s first IPTW at the department of Surgery at Heidelberg University Hospital. Methods: The Kern cycle was used to develop an ITPW curriculum. Practical as well as theoretical considerations guided the design of the IPTW. Common project management tools including blueprinting and RASCI (Responsibility, Approval, Support, Consultation, Information) matrix were applied. Results: Since April 2017, 7 cohorts of students and trainees have had four-week long placements on HIPSTA. They run the IPTW in early and late shifts. Nursing and medical facilitators are supporting the IP team as needed. Learning objectives are operationalized as EPAs (entrustable professional activities) and interprofessional learning goals. Since initiation only minor modifications to the curriculum have been necessary and satisfaction of students/trainees, facilitators and patients is high. Conclusion: IPTWs can be established and run in the German health care system even in a complex clinical setting. The early involvement of all professions in a steering group seems to be key to success. Nursing and medical facilitators are of utmost importance for daily routine. The experiences outlined here could help others aiming to implement IPTWs at their sites. IPTWs might address a number of hitherto unaddressed educational needs. Trial registration: Not applicable.


Asunto(s)
Empleos en Salud , Estudiantes de Enfermería , Austria , Alemania , Humanos , Relaciones Interprofesionales , Suiza
15.
Eur J Cancer ; 93: 119-126, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29501977

RESUMEN

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.

16.
J Gastrointest Surg ; 22(8): 1418-1433, 2018 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-29589264

RESUMEN

BACKGROUND: While several trials have compared laparoscopic to open surgery for colon cancer showing similar oncological results, oncological quality of laparoscopic versus open rectal resection is not well investigated. METHODS: A systematic literature search for randomized controlled trials was conducted in MEDLINE, the Cochrane Library, and Embase. Qualitative and quantitative meta-analyses of short-term (rate of complete resections, number of harvested lymph nodes, circumferential resection margin positivity) and long-term (recurrence, disease-free and overall survival) oncologic results were conducted. RESULTS: Fourteen randomized controlled trials were identified including 3528 patients. Patients in the open resection group had significantly more complete resections (OR 0.70; 95% CI 0.51-0.97; p = 0.03) and a higher number of resected lymph nodes (mean difference - 0.92; 95% CI - 1.08 to 0.75; p < 0.001). No differences were detected in the frequency of positive circumferential resection margins (OR 0.82; 95% CI 0.62-1.10; p = 0.18). Furthermore, no significant differences of long-term oncologic outcome parameters after 5 years including locoregional recurrence (OR 0.95; 95% CI 0.44-2.05; p = 0.89), disease-free survival (OR 1.16; 95% CI 0.84-1.58; p = 0.36), and overall survival (OR 1.04; 95% CI 0.76-1.41; p = 0.82) were found. Most trials exhibited a relevant risk of bias and several studies provided no information on the surgical expertise of the participating surgeons. CONCLUSION: Differences in oncologic outcome between laparoscopic and open rectal surgery for rectal cancer were detected for the complete resection rate and the number of resected lymph nodes in favor of the open approach. No statistically significant differences were found in oncologic long-term outcome parameters.

17.
Gastric Cancer ; 21(2): 303-314, 2018 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-28685209

RESUMEN

BACKGROUND: The optimal surgical approach for adenocarcinoma directly at the esophagogastric junction (AEG II) is still under debate. This study aims to evaluate the differences between right thoracoabdominal esophagectomy (TAE) (Ivor-Lewis operation) and transhiatal extended gastrectomy (THG) for AEG II. METHODS: From a prospective database, 242 patients with AEG II (TAE, n = 56; THG, n = 186) were included and analyzed according to characteristics and perioperative morbidity and mortality and overall survival (chi-square, Mann-Whitney U, log-rank, Cox regression). RESULTS: Groups were comparable at baseline with exception of age. Patients older than 70 years were more frequently resected by THG (p = 0.003). No differences in perioperative morbidity (p = 0.197) and mortality (p = 0.711) were observed, including anastomotic leakages (p = 0.625) and pulmonary complications (p = 0.494). There was no significant difference in R0 resection (p = 0.719) and number of resected lymph nodes (p = 0.202). Overall median survival was 38.4 months. Survival after TAE was significantly longer than after THG (median OS not reached versus 33.6 months, p = 0.02). Multivariate analysis revealed pN-category (p < 0.001) and type of surgery (p = 0.017) as independent prognostic factors. The type of surgery was confirmed as prognostic factor in locally advanced AEG II (cT 3/4 or cN1), but not in cT1/2 and cN0 patients. CONCLUSIONS: Our single-center experience suggests that patients with (locally advanced) AEG II tumors may benefit from TAE compared to THG. For further evaluation, a randomized trial would be necessary.


Asunto(s)
Adenocarcinoma/cirugía , Esofagectomía/métodos , Unión Esofagogástrica/cirugía , Gastrectomía/métodos , Adenocarcinoma/mortalidad , Adulto , Anciano , Neoplasias Esofágicas/mortalidad , Neoplasias Esofágicas/cirugía , Esofagectomía/mortalidad , Femenino , Gastrectomía/mortalidad , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Neoplasias Gástricas/mortalidad , Neoplasias Gástricas/cirugía
18.
Langenbecks Arch Surg ; 403(1): 119-129, 2018 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-29209758

RESUMEN

BACKGROUND: The aim of the present study was to determine empirically which electronic databases contribute best to a literature search in surgical systematic reviews. METHODS: For ten published systematic reviews, the systematic literature searches were repeated in the databases MEDLINE, Web of Science, CENTRAL, and EMBASE. On the basis of these reviews, a gold standard set of eligible articles was created. Recall (%), precision (%), unique contribution (%), and numbers needed to read (NNR) were calculated for each database, as well as for searches of citing references and of the reference lists of related systematic reviews (hand search). RESULTS: CENTRAL yielded the highest recall (88.4%) and precision (8.3%) for randomized controlled trials (RCT), MEDLINE for non-randomized studies (NRS; recall 92.6%, precision 5.2%). The most effective combination of two databases plus hand searching for RCT was MEDLINE/CENTRAL (98.6% recall, NNR 97). Adding EMBASE marginally increased the recall to 99.3%, but with an NNR of 152. For NRS, the most effective combination was MEDLINE/Web of Science (99.5% recall, NNR 60). CONCLUSIONS: For surgical systematic reviews, the optimal literature search for RCT employs MEDLINE and CENTRAL. For surgical systematic reviews of NRS, Web of Science instead of CENTRAL should be searched. EMBASE does not contribute substantially to reviews with a surgical intervention.


Asunto(s)
Bases de Datos Factuales , Descubrimiento Basado en la Literatura , Literatura de Revisión como Asunto , Humanos
19.
Lancet ; 390(10099): 1027-1037, 2017 Sep 09.
Artículo en Inglés | MEDLINE | ID: mdl-28901935

RESUMEN

BACKGROUND: There is substantial uncertainty regarding the optimal surgical treatment for chronic pancreatitis. Short-term outcomes have been found to be better after duodenum-preserving pancreatic head resection (DPPHR) than after partial pancreatoduodenectomy. Therefore, we designed the multicentre ChroPac trial to investigate the long-term outcomes of patients with chronic pancreatitis within 24 months after surgery. METHODS: This randomised, controlled, double-blind, parallel-group, superiority trial was done in 18 hospitals across Europe. Patients with chronic pancreatitis who were planned for elective surgical treatment were randomly assigned to DPPHR or partial pancreatoduodenectomy with a central web-based randomisation tool. The primary endpoint was mean quality of life within 24 months after surgery, measured with the physical functioning scale of the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Primary analysis included all patients who underwent one of the assigned procedures; safety analysis included all patients who underwent surgical intervention (categorised into groups as treated). Patients and outcome assessors were masked to group assignment. The trial was registered, ISRCTN38973832. Recruitment was completed on Sept 3, 2013. FINDINGS: Between Sept 10, 2009, and Sept 3, 2013, 250 patients were randomly assigned to DPPHR (n=125) or partial pancreatoduodenectomy (n=125), of whom 226 patients (115 in the DPPHR group and 111 in the partial pancreatoduodenectomy group) were analysed. No difference in quality of life was seen between the groups within 24 months after surgery (75·3 [SD 16·4] for partial pancreatoduodenectomy vs 73·0 [16·4] for DPPHR; mean difference -2·3, 95% CI -6·6 to 2·0; p=0·284). The incidence and severity of serious adverse events did not differ between the groups. 70 (64%) of 109 patients in the DPPHR group and 61 (52%) of 117 patients in the partial pancreatoduodenectomy group had at least one serious adverse event, with the most common being reoperations (for reasons other than chronic pancreatitis), gastrointestinal problems, and other surgical morbidity. INTERPRETATION: No differences in quality of life after surgery for chronic pancreatitis were seen between the interventions. Results from single-centre trials showing superiority for DPPHR were not confirmed in the multicentre setting. FUNDING: German Research Foundation (DFG).


Asunto(s)
Duodeno/cirugía , Tratamientos Conservadores del Órgano/métodos , Pancreatectomía/métodos , Pancreaticoduodenectomía/métodos , Pancreatitis Crónica/cirugía , Método Doble Ciego , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento
20.
HPB (Oxford) ; 19(11): 1001-1007, 2017 11.
Artículo en Inglés | MEDLINE | ID: mdl-28838632

RESUMEN

BACKGROUND: Neoadjuvant therapy is an important strategy for locally advanced pancreatic cancer (PDAC) as resection rates increase with modern chemotherapy regimens even in patients with arterial tumor encasement. The aim of this study is the description of technique and initial outcomes of a new type of radical and arterial-sparing resection after neoadjuvant treatment for locally advanced PDAC. METHODS: The surgical technique and perioperative results of a new type of operation are described, comprising radical tumor removal by sharp dissection along the celiac axis and the superior mesenteric artery with complete dissection of all soft tissue between both - arteries and superior mesenteric/portal vein (TRIANGLE operation). RESULTS: 15 patients underwent artery-preserving tumor removal without mortality, 7/15 patients showed postoperative complications and an R0 resection was achieved in 6/15 patients. Functional outcome was good in 11/15 patients despite the extended approach of dissection. CONCLUSION: After neoadjuvant therapy for locally advanced PDAC, surgical exploration should be attempted in patients with stable disease or remission to clarify true vascular infiltration. In case of absent viable tumor, the described technique allows to perform radical surgery without arterial resection in this subgroup of patients.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma Ductal Pancreático/cirugía , Disección/métodos , Terapia Neoadyuvante , Pancreatectomía/métodos , Neoplasias Pancreáticas/cirugía , Pancreaticoduodenectomía/métodos , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Carcinoma Ductal Pancreático/diagnóstico por imagen , Carcinoma Ductal Pancreático/patología , Quimioterapia Adyuvante , Disección/efectos adversos , Femenino , Alemania , Humanos , Masculino , Márgenes de Escisión , Venas Mesentéricas/patología , Venas Mesentéricas/cirugía , Persona de Mediana Edad , Terapia Neoadyuvante/efectos adversos , Invasividad Neoplásica , Pancreatectomía/efectos adversos , Neoplasias Pancreáticas/diagnóstico por imagen , Neoplasias Pancreáticas/patología , Pancreaticoduodenectomía/efectos adversos , Vena Porta/patología , Vena Porta/cirugía , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
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