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      Prevention of incisional hernia after midline laparotomy with prophylactic mesh reinforcement: a meta‐analysis and trial sequential analysis

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          Abstract

          Background

          Incisional hernia is a frequent complication after abdominal surgery. The aim of this study was to assess the efficacy of prophylactic mesh reinforcement (PMR) after midline laparotomy in reducing the incidence of incisional hernia.

          Methods

          A meta‐analysis was conducted following PRISMA guidelines. The primary outcome was the incidence of incisional hernia after follow‐up of at least 12 months. Secondary outcomes were postoperative complications. Only RCTs were included. A random‐effects model was used for the meta‐analysis, and trial sequential analysis was conducted.

          Results

          Twelve RCTs were included, comprising 1815 patients. The incidence of incisional hernia was significantly lower after PMR compared with sutured closure (risk ratio (RR) 0·35, 95 per cent c.i. 0·21 to 0·57; P < 0·001). Both onlay (RR 0·26, 0·11 to 0·67; P = 0·005) and retromuscular (RR 0·28, 0·10 to 0·82; P = 0·02) PMR led to a significant reduction in the rate of incisional hernia. The occurrence of seroma was higher in patients who had onlay PMR (RR 2·23, 1·10 to 4·52; P = 0·03). PMR did not result in an increased rate of surgical‐site infection.

          Conclusion

          PMR of a midline laparotomy using an onlay or retromuscular technique leads to a significant reduction in the rate of incisional hernia in high‐risk patients. Individual risk factors should be taken into account to select patients who will benefit most.

          [Correction added on 19 February 2020, after first online publication: J. García Alamino has been amended to J. M. Garcia‐Alamino]

          Abstract

          Prophylactic mesh reinforcement of a midline laparotomy leads to a significant reduction in the rate of incisional hernia in high‐risk patients, for both onlay and retromuscular mesh reinforcement.

          Mesh high risk patients

          Translated abstract

          Antecedentes

          La eventración (hernia incisional) es una complicación frecuente de la cirugía abdominal. El objetivo es evaluar la eficacia de la inserción de una malla profiláctica de refuerzo ( prophylactic mesh reinforcement, PMR) después de la laparotomía media para reducir la incidencia de eventración.

          Métodos

          Se realizó un metaanálisis siguiendo las recomendaciones PRISMA. La variable principal fue la incidencia de eventración después de un seguimiento mínimo de 12 meses. Las variables secundarias fueron las complicaciones postoperatorias. Solo se incluyeron ensayos controlados aleatorizados. Se utilizó un modelo de efectos aleatorios para el metaanálisis y se realizó un análisis secuencial de los ensayos.

          Resultados

          Se incluyeron 12 ensayos aleatorizados y controlados con 1.815 pacientes. La incidencia de eventración fue significativamente menor después de la PMR en comparación con el cierre simple (riesgo relativo, RR 0,35; i.c. del 95%: 0,21‐0,57, P < 0,0001). Hubo una reducción significativa de la tasa de eventración tanto si la PMR se colocó en posición supra‐aponeurótica (RR 0,26; i.c. del 95% 0,11‐0,67, P = 0,005) como retromuscular (RR 0,28; i.c. del 95% 0,0‐0,82, P = 0,02). La aparición de seromas fue mayor en los pacientes con RPM supra‐aponeurótica (RR 2,23; i.c. del 95% 1,10‐4,52, P = 0,03). La PMR no conllevó una mayor tasa de infecciones de la herida quirúrgica.

          Conclusión

          Una PMR en una laparotomía de la línea media, tanto en posición supra‐aponeurótica como retromuscular, reduce de forma significativa el desarrollo de eventraciones en pacientes de alto riesgo. Se deben considerar los factores de riesgo individuales para seleccionar a los pacientes que más puedan beneficiarse.

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          Most cited references25

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          The Number of Patients and Events Required to Limit the Risk of Overestimation of Intervention Effects in Meta-Analysis—A Simulation Study

          Background Meta-analyses including a limited number of patients and events are prone to yield overestimated intervention effect estimates. While many assume bias is the cause of overestimation, theoretical considerations suggest that random error may be an equal or more frequent cause. The independent impact of random error on meta-analyzed intervention effects has not previously been explored. It has been suggested that surpassing the optimal information size (i.e., the required meta-analysis sample size) provides sufficient protection against overestimation due to random error, but this claim has not yet been validated. Methods We simulated a comprehensive array of meta-analysis scenarios where no intervention effect existed (i.e., relative risk reduction (RRR) = 0%) or where a small but possibly unimportant effect existed (RRR = 10%). We constructed different scenarios by varying the control group risk, the degree of heterogeneity, and the distribution of trial sample sizes. For each scenario, we calculated the probability of observing overestimates of RRR>20% and RRR>30% for each cumulative 500 patients and 50 events. We calculated the cumulative number of patients and events required to reduce the probability of overestimation of intervention effect to 10%, 5%, and 1%. We calculated the optimal information size for each of the simulated scenarios and explored whether meta-analyses that surpassed their optimal information size had sufficient protection against overestimation of intervention effects due to random error. Results The risk of overestimation of intervention effects was usually high when the number of patients and events was small and this risk decreased exponentially over time as the number of patients and events increased. The number of patients and events required to limit the risk of overestimation depended considerably on the underlying simulation settings. Surpassing the optimal information size generally provided sufficient protection against overestimation. Conclusions Random errors are a frequent cause of overestimation of intervention effects in meta-analyses. Surpassing the optimal information size will provide sufficient protection against overestimation.
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            Impact of incisional hernia on health-related quality of life and body image: a prospective cohort study.

            We investigated the impact of incisional hernia (IH) on quality of life and body image.
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              [Factors influencing the development of incisional hernia. A retrospective study of 2,983 laparotomy patients over a period of 10 years].

              Incisional hernia formation is one of the most frequent complications in visceral surgery requiring reoperation. Risk factors for incisional hernia formation and preventive strategies are not clearly defined. In a retrospective study including 2983 patients over a 10-year period, the influence of demographic data, pre-, intra- and postoperative risk factors for incisional hernia development were evaluated. From the subgroups medical history, medication, laboratory values, indication, surgical technique, course of operation, postoperative course and wound healing, altogether 43 parameters were analysed. Statistical evaluation was performed using the chi 2-test according to Pearson, and binary logistic regression analysis. The mean incisional hernia incidence in the study was 4.3%. In the mean follow-up period of 21.1 months, the incisional hernia incidence was calculated at 9.8% using the Kaplan-Meier estimate; for a 10-year period it reached 18.7%. The study revealed that 31.5% of all incisional hernias developed in the first 6 months after the operation, 54.4% after 12 months, 74.8% after 2 years and 88.9% after 5 years. Significant demographic factors influencing incisional hernia incidence were age (> 45 years) and male gender. The preoperative factors anaemia (Hb 25, the intraoperative factors recurrent incision and previous laparotomy, and the postoperative factors catecholamin-therapy and disturbed wound healing were of significant influence. The calculated incisional hernia incidence for a 10 year period of almost 20% and the manifestation of 50% of all hernias more than 12 months after the operation, underline the necessity to intensify surgical research in the field of laparotomy healing. In comparison to demographic and endogenous risk factors, the surgical technique has less influence on laparotomy healing. Measures to ameliorate tissue perfusin seem to exert a positive influence on incisional hernia incidence.
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                Author and article information

                Contributors
                anjairam@hotmail.com
                Journal
                BJS Open
                BJS Open
                10.1002/(ISSN)2474-9842
                BJS5
                BJS Open
                John Wiley & Sons, Ltd (Chichester, UK )
                2474-9842
                14 February 2020
                June 2020
                : 4
                : 3 ( doiID: 10.1002/bjs5.v4.3 )
                : 357-368
                Affiliations
                [ 1 ] Department of Surgery Catharina Hospital Eindhoven Eindhoven Netherlands
                [ 2 ] Department of Surgery Maasstad Ziekenhuis Rotterdam Rotterdam Netherlands
                [ 3 ] Department of General Surgery Erasmus University Medical Centre Rotterdam Netherlands
                [ 4 ] Department of General and Digestive Surgery Hospital Vall d'Hebrón, Universidad Autónoma de Barcelona Barcelona Spain
                [ 5 ] Department of General and Digestive Surgery Hospital Del Mar Barcelona Spain
                [ 6 ] Department of Primary Health Care Sciences University of Oxford Oxford UK
                [ 7 ] Department of Surgery Maria Middelares Hospital Ghent Belgium
                Author notes
                [*] [* ] Correspondence to: Dr A. P. Jairam, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands (e‐mail: anjairam@ 123456hotmail.com )
                Author information
                https://orcid.org/0000-0002-1107-3120
                https://orcid.org/0000-0003-3337-0756
                Article
                BJS550261
                10.1002/bjs5.50261
                7260413
                32057193
                2931c769-a62d-4223-9756-953a9bfb7e7a
                © 2020 The Authors. BJS Open published by John Wiley & Sons Ltd on behalf of British Journal of Surgery Society

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 30 December 2018
                : 17 December 2019
                Page count
                Figures: 7, Tables: 2, Pages: 12, Words: 4343
                Categories
                Incisional Hernia
                Prevention
                Mesh
                Systematic Review
                Systematic Reviews
                Custom metadata
                2.0
                June 2020
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.8.3 mode:remove_FC converted:30.05.2020

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