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      Use of Mesh in Laparoscopic Paraesophageal Hernia Repair: A Meta-Analysis and Risk-Benefit Analysis

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          Abstract

          Introduction

          Mesh augmentation seems to reduce recurrences following laparoscopic paraesophageal hernia repair (LPHR). However, there is an uncertain risk of mesh-associated complications. Risk-benefit analysis might solve the dilemma.

          Materials and Methods

          A systematic literature search was performed to identify randomized controlled trials (RCTs) and observational clinical studies (OCSs) comparing laparoscopic mesh-augmented hiatoplasty (LMAH) with laparoscopic mesh-free hiatoplasty (LH) with regard to recurrences and complications. Random effects meta-analyses were performed to determine potential benefits of LMAH. All data regarding LMAH were used to estimate risk of mesh-associated complications. Risk-benefit analysis was performed using a Markov Monte Carlo decision-analytic model.

          Results

          Meta-analysis of 3 RCTs and 9 OCSs including 915 patients revealed a significantly lower recurrence rate for LMAH compared to LH (pooled proportions, 12.1% vs. 20.5%; odds ratio (OR), 0.55; 95% confidence interval (CI), 0.34 to 0.89; p = 0.04). Complication rates were comparable in both groups (pooled proportions, 15.3% vs. 14.2%; OR, 1.02; 95% CI, 0.63 to 1.65; p = 0.94). The systematic review of LMAH data yielded a mesh-associated complication rate of 1.9% (41/2121; 95% CI, 1.3% to 2.5%) for those series reporting at least one mesh-associated complication. The Markov Monte Carlo decision-analytic model revealed a procedure-related mortality rate of 1.6% for LMAH and 1.8% for LH.

          Conclusions

          Mesh application should be considered for LPHR because it reduces recurrences at least in the mid-term. Overall procedure-related complications and mortality seem to not be increased despite of potential mesh-associated complications.

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          Most cited references38

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          Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses.

          The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with "trial flow", study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement.
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            Proposed classification of complications of surgery with examples of utility in cholecystectomy.

            Lack of uniform reporting of negative outcomes makes interpretation of surgical literature difficult. We attempt to define and classify negative outcomes by differentiating complications, sequelae, and failures. Complications and sequelae result from procedures, adding new problems to the underlying disease. However, complications are unexpected events not intrinsic to the procedure, whereas sequelae are inherent to the procedure. Failures are events in which the purpose of the procedure is not fulfilled. We propose a classification of complications based on four grades: Grade I complications are alterations from the ideal postoperative course, non-life-threatening, and with no lasting disability. Complications of this grade necessitate only bedside procedures and do not significantly extend hospital stay. Grade II complications are potentially life-threatening but without residual disability. Within grade II complications a subdivision is made according to the requirement for invasive procedures. Grade III complications are those with residual disability, including organ resection or persistence of life-threatening conditions. Finally, grade IV complications are deaths as a result of complications. To illustrate the relevance of the classification, we reviewed 650 cases of elective cholecystectomy. Risk factors for development of complications were determined, and the classification was also used to analyze the value of a modified APACHE II as a preoperative prognostic score. Both supported the relevance of the proposed classification. The advantages of such a classification are (1) increased uniformity in reporting results, (2) the ability to compare results of two distinct time periods in a single center, (3) the ability to compare results of surgery between different centers, (4) the ability to compare results of surgical versus nonsurgical measures, (5) the ability to perform adequate metaanalysis, (6) the ability to identify objective preoperative risk factors, and (7) the ability to establish preoperative prognostic scores.
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              Markov models in medical decision making: a practical guide.

              Markov models are useful when a decision problem involves risk that is continuous over time, when the timing of events is important, and when important events may happen more than once. Representing such clinical settings with conventional decision trees is difficult and may require unrealistic simplifying assumptions. Markov models assume that a patient is always in one of a finite number of discrete health states, called Markov states. All events are represented as transitions from one state to another. A Markov model may be evaluated by matrix algebra, as a cohort simulation, or as a Monte Carlo simulation. A newer representation of Markov models, the Markov-cycle tree, uses a tree representation of clinical events and may be evaluated either as a cohort simulation or as a Monte Carlo simulation. The ability of the Markov model to represent repetitive events and the time dependence of both probabilities and utilities allows for more accurate representation of clinical settings that involve these issues.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                15 October 2015
                2015
                : 10
                : 10
                : e0139547
                Affiliations
                [1 ]Department of General, Visceral and Transplant Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany
                [2 ]Department of Psychology, University of Copenhagen, Øster Farimagsgade 2A, 1315, København K, Denmark
                [3 ]Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, 69120, Heidelberg, Germany
                [4 ]The Study Center of the German Surgical Society, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany
                [5 ]General, Visceral, Thoracic and Vascular Surgery, Klinikum Memmingen, Bismarckstraße 23, 87700, Memmingen, Germany
                Heinrich-Heine-University and University Hospital Duesseldorf, GERMANY
                Author notes

                Competing Interests: All authors have declared that no competing interests exist.

                Conceived and designed the experiments: BPM HGK MG MKD MWB LF CG. Performed the experiments: BPM HGK MG CS GRL FF FN MW. Analyzed the data: BPM HGK MG CS GRL FF FN MKD. Contributed reagents/materials/analysis tools: HGK MG CS MKD. Wrote the paper: BPM HGK MG CS GRL FF FN MKD MWB LF.

                Article
                PONE-D-15-10011
                10.1371/journal.pone.0139547
                4607492
                26469286
                e3cb4b8a-e576-4fe8-ac3b-06800190511c
                Copyright @ 2015

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

                History
                : 6 March 2015
                : 14 September 2015
                Page count
                Figures: 6, Tables: 2, Pages: 17
                Funding
                The authors have no support or funding to report.
                Categories
                Research Article
                Custom metadata
                All relevant data are within the paper including figures, tables and three supplements.

                Uncategorized
                Uncategorized

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