Abstract:
OBJECTIVE:To assess the role of registries in the postmarketing surveillance of surgical meshes. BACKGROUND:To date, surgical meshes are classified as group II medical devices. Class II devices do not require premarket clearance by clinical studies. Ethicon initiated a voluntary market withdrawal of Physiomesh for laparoscopic use after an analysis of unpublished data from the 2 large independent hernia registries-Herniamed German Registry and Danish Hernia Database. This paper now presents the relevant data from the Herniamed Registry. METHODS:The present analysis compares the prospective perioperative and 1-year follow-up data collected for all patients with incisional hernia who had undergone elective laparoscopic intraperitoneal onlay mesh repair either with Physiomesh (n = 1380) or with other meshes recommended in the guidelines (n = 3834). RESULTS:Patients with Physiomesh repair had a markedly higher recurrence rate compared with the other recommended meshes (12.0% vs 5.0%; P < 0.001). In the multivariable analysis, the recurrence rate was highly significantly influenced by the mesh type used (P < 0.001). If Physiomesh was used, that led to a highly significant increase in the recurrence rate on 1-year follow-up (odds ratio 2.570, 95% CI 2.057, 3.210). The mesh type used also had a significant influence on chronic pain rates. CONCLUSIONS:The importance of real-world data for postmarketing surveillance of surgical meshes has been demonstrated in this registry-based study. Randomized controlled trials are needed for premarket approval of new devices. The role of sponsorship of device studies by the manufacturing company must be taken into account.
journal_name
Ann Surgjournal_title
Annals of surgeryauthors
Köckerling F,Simon T,Hukauf M,Hellinger A,Fortelny R,Reinpold W,Bittner Rdoi
10.1097/SLA.0000000000002326subject
Has Abstractpub_date
2018-12-01 00:00:00pages
1097-1104issue
6eissn
0003-4932issn
1528-1140journal_volume
268pub_type
杂志文章,多中心研究abstract:OBJECTIVE:To evaluate the effect of inhalation of aerosolized opsonized dead Escherichia coli on inflammatory pulmonary neutrophil (PMN) apoptosis, lung injury, and survival in a PMN-mediated lung injury model in vivo. SUMMARY BACKGROUND DATA:Neutrophils that have transmigrated into an inflammatory focus display incre...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-200202000-00018
更新日期:2002-02-01 00:00:00
abstract::The University of Rochester, Department of Surgery, in response to an experimental community-wide limit on hospital budgets, studied high-cost general surgical patients as a potential source of leverage for containment of hospital costs. It was found that a small number of patients impact significantly on hospital cos...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-198309000-00005
更新日期:1983-09-01 00:00:00
abstract::The purpose of this report is to review the results of mitral valve replacement since a first report in the Annals of Surgery in 1961, in order to determine the relative importance of new valve designs versus other surgical variables. The continued use of the silastic ball valve in its 1966 configuration (Model 6120),...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-198509000-00016
更新日期:1985-09-01 00:00:00
abstract:OBJECTIVE:The effects of interleukin (IL)-6 in the injured patient are examined in an attempt to clarify the potential pathophysiologic role of IL-6 in the response to injury. SUMMARY BACKGROUND DATA:Interleukin-6 is an integral cytokine mediator of the acute phase response to injury and infection. However, prolonged ...
journal_title:Annals of surgery
pub_type: 杂志文章,评审
doi:10.1097/00000658-199611000-00009
更新日期:1996-11-01 00:00:00
abstract:OBJECTIVE:To describe the outcomes of elderly patients with do-not-resuscitate (DNR) status who undergo emergency general surgery and to improve understanding of the relationship between preoperative DNR status and postoperative mortality. BACKGROUND:Preoperative DNR status has previously been shown to predict increas...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e31826578fb
更新日期:2012-09-01 00:00:00
abstract:OBJECTIVE:Perioperative blood transfusions may adversely affect survival in patients with colorectal malignancy, although definite proof of a causal relationship has never been reported. BACKGROUND:We report the long-term outcomes of a randomized controlled trial performed between 1986 and 1991 to compare the effects ...
journal_title:Annals of surgery
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1097/SLA.0b013e318271cedf
更新日期:2012-11-01 00:00:00
abstract:OBJECTIVE:The authors determined the molecular mechanisms for the failure of transforming growth factor-beta (TGF-beta) to inhibit the growth of SW1116 and SW48 colon cancer cell lines. BACKGROUND:Transforming growth factor-beta is a bifunctional regulator of cell growth that typically stimulates proliferation of mese...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-199506000-00015
更新日期:1995-06-01 00:00:00
abstract:OBJECTIVE:To determine the effect of allogeneic blood transfusion (ABT) on clinical outcomes in patients with colorectal cancer undergoing surgery. BACKGROUND:Perioperative ABTs may be associated with adverse clinical outcomes. METHODS:Systematic review of the literature with odds ratio (OR) and incidence rate ratio ...
journal_title:Annals of surgery
pub_type: 杂志文章,meta分析,评审
doi:10.1097/SLA.0b013e31825b35d5
更新日期:2012-08-01 00:00:00
abstract:OBJECTIVE:We have previously demonstrated that P. aeruginosa can have profound effects on the intestinal epithelial barrier via one of its virulence factors, the PA-I lectin/adhesin. The aims of the present study were to further characterize the interaction of P. aeruginosa and the intestinal epithelium using both in v...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/01.sla.0000094551.88143.f8
更新日期:2003-11-01 00:00:00
abstract:OBJECTIVE:To compare the outcomes of bilateral subtotal (BST) versus total thyroidectomy (TT) for benign bilateral thyroid disease (BBTD). BACKGROUND:The extent of thyroid resection in benign goiter is controversial. Potential advantages of TT over BST may include: one-stage removal of incidental thyroid cancer, and a...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e3182360118
更新日期:2011-11-01 00:00:00
abstract:OBJECTIVE:The aim of this study is to evaluate the short-term outcomes and long-term survival of laparoscopic rectal cancer resection at a single institution with 579 cases over a 15-year period. SUMMARY BACKGROUND DATA:The use of laparoscopic resection for colon cancer has been shown to be safe with comparable oncolo...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e31818e418a
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Aortic elasticity creates a cushion that protects the heart from pressure injury, and a recoil that helps perfuse the coronary arteries. TEVAR has become first-line therapy for many aortic pathologies including trauma, but stent-grafts stiffen the aorta and likely increase LV afterload. OBJECTIVE:Test the h...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000003768
更新日期:2020-01-03 00:00:00
abstract:OBJECTIVE:The aim of this study was to determine the contribution of the hepatic artery, gastroduodenal artery, and portal vein to the microvascular blood flow in the common bile duct (CBD). BACKGROUND:Biliary complications are a common cause of graft loss after liver transplantation. The occurrence is, partly, attrib...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e31824714d0
更新日期:2012-03-01 00:00:00
abstract:BACKGROUND:The advice to individuals with identified CDH1 mutations is generally to undertake prophylactic total gastrectomy (PTG). This study evaluated the effect of PTG on health-related quality of life (HRQL) in asymptomatic individuals with identified CDH1 mutations at high risk for gastric cancer. METHODS:Individ...
journal_title:Annals of surgery
pub_type: 杂志文章,多中心研究
doi:10.1097/SLA.0000000000000446
更新日期:2014-07-01 00:00:00
abstract:OBJECTIVE:This study aims to evaluate whether graduates of integrated vascular surgery residency (IVSR) programs achieve similar surgical outcomes in clinical practice as compared to graduates of vascular surgery fellowships (VSF). SUMMARY BACKGROUND DATA:Early sub-specialization through IVSR programs decreases the to...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000004706
更新日期:2020-12-18 00:00:00
abstract:OBJECTIVE:To prospectively assess the accuracy of gadofosveset-enhanced magnetic resonance imaging (MRI) for nodal staging and restaging in rectal cancer. BACKGROUND:Accurate preoperative assessment of nodal disease in rectal cancer impacts treatment management. Staging with modern imaging techniques (computed tomogra...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e31820b01f1
更新日期:2011-03-01 00:00:00
abstract:OBJECTIVES:Congenital diaphragmatic hernia (CDH) remains a significant cause of neonatal morbidity and mortality. SUMMARY OF BACKGROUND DATA:Previous studies have suggested that hospital volume is an independent predictor of in-hospital mortality. We sought to validate this effect using a large national database incor...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e3181f5b538
更新日期:2010-10-01 00:00:00
abstract::The proportion of the population of the U.S. 65 years of age and over is increasing. Biliary tract disease is estimated to involve 15% of the adult population. A review of 12,200 patients treated surgically at one medical center reveals that 2401 (20%) had acute cholecystitis. There were 93 deaths, for a mortality rat...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-198101000-00009
更新日期:1981-01-01 00:00:00
abstract:OBJECTIVE:The authors investigate the recovery of gastrointestinal motility in the fed and fasted state after laparoscopic and open cholecystectomy. SUMMARY BACKGROUND DATA:Clinical recovery after laparoscopic cholecystectomy is known to be more rapid than after conventional open cholecystectomy. However, the actual e...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-199604000-00010
更新日期:1996-04-01 00:00:00
abstract::A new approach for preventing and treating sepsis due to central venous catheter (CVC) has been devised at the Istituto Nazionale Tumori of Milan. A prospective protocol has been developed that includes the weekly exchange of the CVC via a guidewire as well as its exchange when a CVC-related sepsis is suspected. Growt...
journal_title:Annals of surgery
pub_type: 临床试验,杂志文章
doi:10.1097/00000658-198307000-00009
更新日期:1983-07-01 00:00:00
abstract:OBJECTIVE:To establish reliable standards for surgical application to elderly patients 75 years old or older with gastric or colorectal cancer with special reference to the postoperative recovery of activities of daily living (ADL) and quality of life (QOL). SUMMARY BACKGROUND DATA:ADL and QOL are important outcomes o...
journal_title:Annals of surgery
pub_type: 杂志文章,多中心研究
doi:10.1097/SLA.0b013e3180caa3fb
更新日期:2007-08-01 00:00:00
abstract:BACKGROUND:Although a randomized trial demonstrated a survival benefit of cytoreductive surgery (CRS) and intraperitoneal chemotherapy (IPC) over systemic chemotherapy alone, the treatment of peritoneal carcinomatosis from colorectal cancer (CRPC) is still a matter of debate. The aims of this study were to evaluate lon...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0b013e31827e9289
更新日期:2013-06-01 00:00:00
abstract:OBJECTIVE:An analysis of the injuries and treatment of the first 100 patients from the Syrian civil war was conducted to monitor quality of care and outcome. SUMMARY BACKGROUND DATA:As reports of the collapse of health care systems in regions within Syria reach the media, patients find themselves crossing the border i...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000001230
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVE:To compare resection rates and outcome of patients subsequently referred with hepatic metastases whose initial colon cancers were resected by surgeons with different specialty interests. SUMMARY BACKGROUND DATA:Variation in practice among noncolorectal specialist surgeons has led to recommendations that colo...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-199912000-00004
更新日期:1999-12-01 00:00:00
abstract::This study examines the influence of total parenteral nutrition (TPN) compared with 5% dextrose (D5) infusion on skeletal muscle and adipose tissue lipoprotein lipase (LPL) activity in nutritionally depleted, injured and infected patients. The plasma concentrations of glucose, free fatty acid (FFA), triglyceride and i...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-198112000-00003
更新日期:1981-12-01 00:00:00
abstract::From 1979 to 1983, 1726 carotid endarterectomies were performed at the Cleveland Clinic. During this period, 39 men (mean age, 60 years) and 22 women (mean age, 63 years) required 65 reoperations (3.8%) for correction of recurrent carotid stenosis occurring 3 to 194 months (mean, 42 months) after previous endarterecto...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-198507000-00004
更新日期:1985-07-01 00:00:00
abstract:OBJECTIVE:To characterize national trends in procedural management of renal trauma. BACKGROUND:Management of renal trauma has evolved to favor a more conservative approach. For patients requiring intervention, there is a paucity of information to characterize the nature of procedural therapy administered. METHODS:A r...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000002475
更新日期:2019-02-01 00:00:00
abstract:OBJECTIVE:To evaluate the impact of health insurance expansion on racial disparities in severity of peripheral arterial disease. BACKGROUND:Lack of insurance and non-white race are associated with increased severity, increased amputation rates, and decreased revascularization rates in patients with peripheral artery d...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/SLA.0000000000001310
更新日期:2016-04-01 00:00:00
abstract:OBJECTIVE:To evaluate the first 1000 liver transplants performed at UCLA Medical Center to determine factors responsible for improved results. SUMMARY BACKGROUND DATA:Liver transplant has evolved impressively since the first case was performed in 1963. The 1980s have highlighted this progress with the development of b...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-199405000-00007
更新日期:1994-05-01 00:00:00
abstract:OBJECTIVE:To evaluate the correlation between the morphologic nuclear features and clinicopathologic parameters in patients with advanced gastric cancer. SUMMARY BACKGROUND DATA:Nuclear profiles have been reported as useful prognostic predictors in various cancers. Data from computerized morphometries are objective an...
journal_title:Annals of surgery
pub_type: 杂志文章
doi:10.1097/00000658-199901000-00007
更新日期:1999-01-01 00:00:00