Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial.

OBJECTIVE: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting.Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. METHODS: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. RESULTS: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. CONCLUSIONS: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair. TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).

Textbook outcome as a composite outcome measure in non-small-cell lung cancer surgery.

OBJECTIVES: Quality assessment is an important element in providing surgical cancer care. The main objective of this study was to develop a new composite measure 'textbook outcome', to evaluate and improve quality of surgical care for patients undergoing a resection for non-small-cell lung cancer (NSCLC). METHODS: All patients undergoing an anatomical resection for NSCLC from 2012 to 2016 registered in the nationwide Dutch Lung Cancer Audit were included in an analysis to assess usefulness of a composite measure as a quality indicator. Based on expert opinion, textbook outcome was defined as having a complete resection (negative resection margins and sufficient lymph node dissection), plus no 30-day or in-hospital mortality, no reintervention in 30 days, no readmission to the intensive care unit, no prolonged hospital stay (<14 days), no hospital readmission after discharge and no major complications. The percentage of patients with a textbook outcome was calculated per hospital. Between-hospital variation in textbook outcome was analysed using case-mix adjustment models. RESULTS: In total, 5513 patients were included in this study. Textbook outcome was achieved in 26.4% of patients. Insufficient lymph node dissection had the most substantial effect on not realizing textbook outcome. If 'sufficient lymph node dissection' was not included as a criterion, textbook outcome would be 60.7%. Case-mix adjusted textbook outcome proportions per hospitals varied between 13.2% and 37.7%. CONCLUSIONS: In contrast to focusing on a single aspect, the composite measure textbook outcome provides insight into comprehensive performance in NSCLC surgery. It can be used to evaluate both individual hospitals and national performance and provides the opportunity to give benchmarked feedback to thoracic surgeons.

Surgical treatment of pulmonary metastases in the Netherlands: data from the Dutch Lung Cancer Audit for Surgery.

OBJECTIVES: Surgical resection is widely employed as a potential curative treatment option for patients with limited lung metastases originating from a wide range of primary tumours. However, there are no clear national or international practice guidelines and, thereby, the risk for potential practice variation exists. This study aims to define the current practice for the surgical treatment of pulmonary metastases in the Netherlands by using data from the Dutch Lung Cancer Audit for Surgery (DLCA-S). METHODS: Data from the DLCA-S were used to analyse patients undergoing a parenchymal lung resection for the treatment of pulmonary metastases between 2012 and 2017. Volume of metastasectomies per hospital was calculated as a proportion of the volume of primary lung cancer resection. Studied outcomes were overall complications and postoperative mortality and complicated course. For the latter, both the national average and between-hospital variation were calculated. RESULTS: A total of 2090 patients, distributed over 45 Dutch hospitals, were included for analysis. The most common primary cancer was colorectal carcinoma (N = 1087, 52.0%) followed by the urogenital carcinoma (N = 296, 14.2%). The most common type of parenchymal resection was a wedge resection (N = 1477, 70.7%) followed by a lobectomy (N = 424, 20.3%). Resection was performed minimally invasively in 1548 patients (74.1%) with a conversion rate of 3.8%. Resection of a solitary metastasis was performed in 1663 patients (79.6%). In 40 patients (1.9%), 4 or more metastases were resected. A postoperative complicated course was noted in 3.6%, and the 30-day mortality rate was 0.7%. The variety between hospitals in the volume of metastasectomies in proportion to the volume of primary lung cancer resections was 3.4-41.5%. CONCLUSIONS: This analysis of the DLCA-S registry provides a unique insight into current practice on pulmonary metastasectomies in the Netherlands over a 6-year period. The rate of postoperative adverse outcome was limited, and the morbidity and mortality were lower compared to primary lung cancer resections in the DLCA-S database.

Dutch Lung Surgery Audit: A National Audit Comprising Lung and Thoracic Surgery Patients.

BACKGROUND: The nationwide Dutch Lung Surgery Audit (DLSA) started in 2012 to monitor and evaluate the quality of lung operations in The Netherlands as an improvement tool. This outline describes the establishment, structure, and organization of the audit by the Dutch Society of Lung Surgeons (NVvL) and the Dutch Society of Cardiothoracic Surgeons (NVT), in collaboration with the Dutch Institute for Clinical Auditing. In addition, the first 4-year results are presented. METHODS: The NVvL and NVT initiated a web-based registration, including weekly updated online feedback for participating hospitals. Data verification by external data managers is performed on regular basis. The audit is incorporated in national quality improvement programs, and participation in the DLSA is mandatory by health insurance organizations and the National Healthcare Inspectorate. RESULTS: Between January 1, 2012, and December 31, 2015, all hospitals performing lung operations participated, and a total of 19,557 patients were registered from which almost half comprised lung cancer patients. Nationwide the guideline adherence increased over the years, and 96.5% of lung cancer patients were discussed in preoperative multidisciplinary teams. Overall postoperative complications and mortality after non-small cell lung cancer operations were 15.5% and 2.0%, respectively. CONCLUSIONS: The audit provides reliable benchmarked information for caregivers and hospital management with potential to start local, regional, or national improvement initiatives. Currently, the audit is further completed with data from nonsurgical lung cancer patients, including treatment data from pulmonary oncologists and radiation oncologists. This will ultimately provide a comprehensive overview of lung cancer treatment in The Netherlands.

Guidelines-based diagnostic process does increase hospital delay in a cohort of colorectal cancer patients: a population-based study.

This is an investigation of factors determining hospital delay until treatment in an unrestricted population of colorectal cancer patients in the western part of the Netherlands. All patients with newly diagnosed colon (n=2146) and rectal carcinoma (n=1036) in the period 2006-2008 were included in analyses of inhospital delay (first hospital visit until first treatment >35 days). One-third of all patients were also available for analyses of prehospital delay (enrollment until first hospital visit >7 days). Patient, tumour and process factors predicting delay were examined in logistic regression models. The median prehospital and inhospital time intervals were 2 days [(p25-p75) 0-16] and 32 days (17-49), respectively, for colon cancer patients and 7 days (1-21) and 43 days (33-60) for rectal cancer patients. After adjustment for patient and tumour factors, colon and rectal cancer patients with first hospital visit before histological confirmation of cancer, complete diagnostic assessment or discussed in a multidisciplinary meeting had a higher probability of increased inhospital delay. Furthermore, first hospital visit before histological confirmation of cancer was associated with decreased prehospital delay in colon and rectal cancer patients. A guidelines-based diagnostic process (considered high quality of care) and multidisciplinary collaboration were associated with increased hospital delay in colorectal cancer patients.

Aspergilloma of the lung due to aspiration during nasal tube feeding.

An aspergilloma usually arises in a preexisting cavity in the lungs. We report a case of a young woman with anorexia nervosa who developed an aspergilloma some time after she suffered pneumonia due to aspiration during nasal tube feeding.

High-volume versus low-volume for esophageal resections for cancer: the essential role of case-mix adjustments based on clinical data.

BACKGROUND: Most studies addressing the volume-outcome relationship in complex surgical procedures use hospital mortality as the sole outcome measure and are rarely based on detailed clinical data. The lack of reliable information about comorbidities and tumor stages makes the conclusions of these studies debatable. The purpose of this study was to compare outcomes for esophageal resections for cancer in low- versus high-volume hospitals, using an extensive set of variables concerning case-mix and outcome measures, including long-term survival. METHODS: Clinical data, from 903 esophageal resections performed between January 1990 and December 1999, were retrieved from the original patients' files. Three hundred and forty-two patients were operated on in 11 low-volume hospitals (<7 resections/year) and 561 in a single high-volume center. RESULTS: Mortality and morbidity rates were significantly lower in the high-volume center, which had an in-hospital mortality of 5 vs 13% (P < .001). On multivariate analysis, hospital volume, but also the presence of comorbidity proved to be strong prognostic factors predicting in-hospital mortality (ORs 3.05 and 2.34). For stage I and II disease, there was a significantly better 5-year survival in the high-volume center. (P = .04). CONCLUSIONS: Hospital volume and comorbidity patterns are important determinants of outcome in esophageal cancer surgery. Strong clinical endpoints such as in-hospital mortality and survival can be used as performance indicators, only if they are joined by reliable case-mix information.