Use of a bioabsorbable mesh in midline laparotomy closure to prevent incisional hernia: randomized controlled trial.

INTRODUCTION: The objective was to assess the effectiveness and safety of a bioabsorbable mesh at the time of closure of a midline laparotomy for IH prevention. MATERIALS AND METHODS: A multicenter, randomized clinical trial including patients undergoing abdominal surgical procedures through a midline laparotomy incision was designed. In the group of mesh (n = 167) the incision was closed using a continuous polydioxanone suture (PDS) plus a bioabsorbable mesh. In the control group (n = 165) a continuous PDS single layer suture was only used. Patients were randomly assigned (1:1) to the two groups. The primary outcome was the incidence of IH at 6, 12 and 24 months. Assessment of IH was done using a CT scan. RESULTS: At 6 months, the rates of IH were 15.2% and 24.8% in the experimental and control groups, respectively (relative risk [RR] 0.66, 95% confidence interval [CI] 0.38-0.98, P = 0.042). At 12 months, the rate of IH continued to be significantly lower in the experimental group (21.4% vs. 33.1%, P = 0.033), but at 24 months, there were no significant differences between the study groups with a follow-up rate of only 37.5%. The number needed to treat (NNT) was 11 and 9 at 6 and 12 months, respectively. CONCLUSION: The bioabsorbable mesh significantly prevented IH during the first year. Not reliable conclusions can be drawn across the second year. This may suggest that the any of the closing technique assessed in this study would have a "palliative" transient effect for preventing IH in the long-term.

Prioritization criteria of patients on scheduled waiting lists for abdominal wall hernia surgery: a cross-sectional study.

PURPOSE: Long delays in waiting lists have a negative impact on the principles of equity and providing timely access to care. This study aimed to assess waiting lists for abdominal wall hernia repair (incisional ventral vs. inguinal hernia) to define explicit prioritization criteria. METHODS: A cross-sectional single-center study was designed. Patients in the waiting list for incisional/ventral hernia (n = 42) and inguinal hernia (n = 50) repair were interviewed by phone and completed health-related quality of life (HRQoL) questionnaires (EQ-5D, COMI-hernia, HerQLes) as a measure of severity. Priority was measured as hernia complexity, patient frailty using the modified frailty index (mFI-11), and the consumption of analgesics for hernia. RESULTS: The mean (SD) time on the waiting list was 5.5 (3.2) months (range 1-14). Complex hernia was present in 34.8% of the patients. HRQoL was moderately poor in patients with incisional/ventral hernia (mean HerQL score 66.1), whereas it was moderately good in patients with inguinal hernia (mean COMI-hernia score 3.40). The use of analgesics was higher in patients with incisional/ventral hernia as compared with those with inguinal hernia (1.48 [0.54] vs. 1.31 [0.51], P = 0.021). Worst values of mFI were associated with inguinal hernia as compared with incisional/ventral hernia (0.21 [0.14] vs. 0.12 [0.11]; P = 0.010). CONCLUSION: Explicit criteria for prioritization in the waiting lists may be the consumption of analgesics for patients with incisional/ventral hernia and frailty for patients with inguinal hernia. A reasonable approach seems to establish separate waiting lists for incisional/ventral hernia and inguinal hernia repair.

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

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].

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.

Use of Topical Antibiotics before Primary Incision Closure to Prevent Surgical Site Infection: A Meta-Analysis.

Background: Surgical site infections (SSIs) remains a concern for surgeons because of the negative impact on outcomes and health care costs. Our purpose was to assess whether topical antibiotics before primary incision closure reduced the rate of SSIs. Methods: Systematic review of MEDLINE/PubMed, Scopus, CINAHL, and Web of Science databases from inception to January 2017. Only randomized controlled trials (RCTs) were retrieved. The primary outcome was the SSI rate. Meta-analysis was complemented with trial sequential analysis (TSA). Results: Thirty-five RCTs (10,870 patients) were included. Only ß-lactams and aminoglycosides were used. A substantial reduction of the incidence of SSIs with the application of antibiotic agents before incision closure (risk ratio [RR] 0.49, 95% confidence interval [CI] 0.37-0.64) was found, which remained in the analysis of 12 RCTs after removal of studies of uncertain quality. The use of ß-lactams was effective to reduce SSI in elective surgery only (RR 0.33, 95% CI 0.13-0.85). In clean-contaminated fields and as an irrigation solution, ß-lactams did not reduce the risk of SSI. Aminoglycosides were not effective (RR 0.74, 95% CI 0.49-1.10). After TSA, the evidence accumulated was far below the optimal information size. The heterogeneity of studies was high and methodological quality of most RCTs included in the meta-analysis was uncertain. Conclusions: Results of this meta-analysis show the data present in the literature are not sufficiently robust and, therefore, the use of topical ß-lactams or aminoglycosides before incision closure to reduce SSI cannot be recommended or excluded.

EHS clinical guidelines on the management of the abdominal wall in the context of the open or burst abdomen.

PURPOSE: To provide guidelines for all surgical specialists who deal with the open abdomen (OA) or the burst abdomen (BA) in adult patients both on the methods used to close the musculofascial layers of the abdominal wall, and regarding possible materials to be used. METHODS: The guidelines were developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach including publications up to January 2017. When RCTs were available, outcomes of interest were quantitatively synthesized by means of a conventional meta-analysis. When only observational studies were available, a meta-analysis of proportions was done. The guidelines were written using the AGREE II instrument. RESULTS: For many of the Key Questions that were researched, there were no high quality studies available. While some strong recommendations could be made according to GRADE, the guidelines also contain good practice statements and clinical expertise guidance which are distinct from recommendations that have been formally categorized using GRADE. RECOMMENDATIONS: When considering the OA, dynamic closure techniques should be prioritized over the use of static closure techniques (strong recommendation). However, for techniques including suture closure, mesh reinforcement, component separation techniques and skin grafting, only clinical expertise guidance was provided. Considering the BA, a clinical expertise guidance statement was advised for dynamic closure techniques. Additionally, a clinical expertise guidance statement concerning suture closure and a good practice statement concerning mesh reinforcement during fascial closure were proposed. The role of advanced techniques such as component separation or relaxing incisions is questioned. In addition, the role of the abdominal girdle seems limited to very selected patients.

EHS clinical guidelines on the management of the abdominal wall in the context of the open or burst abdomen

To provide guidelines for all surgical specialists who deal with the open abdomen (OA) or the burst abdomen (BA) in adult patients both on the methods used to close the musculofascial layers of the abdominal wall, and regarding possible materials to be used. The guidelines were developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach including publications up to January 2017. When RCTs were available, outcomes of interest were quantitatively synthesized by means of a conventional meta-analysis. When only observational studies were available, a meta-analysis of proportions was done. The guidelines were written using the AGREE II instrument. For many of the Key Questions that were researched, there were no high quality studies available. While some strong recommendations could be made according to GRADE, the guidelines also contain good practice statements and clinical expertise guidance which are distinct from recommendations that have been formally categorized using GRADE. When considering the OA, dynamic closure techniques should be prioritized over the use of static closure techniques (strong recommendation). However, for techniques including suture closure, mesh reinforcement, component separation techniques and skin grafting, only clinical expertise guidance was provided. Considering the BA, a clinical expertise guidance statement was advised for dynamic closure techniques. Additionally, a clinical expertise guidance statement concerning suture closure and a good practice statement concerning mesh reinforcement during fascial closure were proposed. The role of advanced techniques such as component separation or relaxing incisions is questioned. In addition, the role of the abdominal girdle seems limited to very selected patients.

European Hernia Society guidelines on prevention and treatment of parastomal hernias.

BACKGROUND: International guidelines on the prevention and treatment of parastomal hernias are lacking. The European Hernia Society therefore implemented a Clinical Practice Guideline development project. METHODS: The guidelines development group consisted of general, hernia and colorectal surgeons, a biostatistician and a biologist, from 14 European countries. These guidelines conformed to the AGREE II standards and the GRADE methodology. The databases of MEDLINE, CINAHL, CENTRAL and the gray literature through OpenGrey were searched. Quality assessment was performed using Scottish Intercollegiate Guidelines Network checklists. The guidelines were presented at the 38th European Hernia Society Congress and each key question was evaluated in a consensus voting of congress participants. RESULTS: End colostomy is associated with a higher incidence of parastomal hernia, compared to other types of stomas. Clinical examination is necessary for the diagnosis of parastomal hernia, whereas computed tomography scan or ultrasonography may be performed in cases of diagnostic uncertainty. Currently available classifications are not validated; however, we suggest the use of the European Hernia Society classification for uniform research reporting. There is insufficient evidence on the policy of watchful waiting, the route and location of stoma construction, and the size of the aperture. The use of a prophylactic synthetic non-absorbable mesh upon construction of an end colostomy is strongly recommended. No such recommendation can be made for other types of stomas at present. It is strongly recommended to avoid performing a suture repair for elective parastomal hernia. So far, there is no sufficient comparative evidence on specific techniques, open or laparoscopic surgery and specific mesh types. However, a mesh without a hole is suggested in preference to a keyhole mesh when laparoscopic repair is performed. CONCLUSION: An evidence-based approach to the diagnosis and management of parastomal hernias reveals the lack of evidence on several topics, which need to be addressed by multicenter trials. Parastomal hernia prevention using a prophylactic mesh for end colostomies reduces parastomal herniation. Clinical outcomes should be audited and adverse events must be reported.

Triclosan-coated sutures and surgical site infection in abdominal surgery: the TRISTAN review, meta-analysis and trial sequential analysis.

INTRODUCTION: Surgical site infection (SSI) is a frequent complication of abdominal surgery causing increased morbidity. Triclosan-coated sutures are recommended to reduce SSI. The aim of this systematic review and meta-analysis was to evaluate the evidence from randomized controlled trials (RCT) comparing the rate of SSI in abdominal surgery when using triclosan-coated or uncoated sutures for fascial closure. METHODS: A systematic literature search was conducted using Medline, EMBASE, the Cochrane library, CINAHL, Scopus and Web of Science including publications until August 2017. The quality of the RCTs was evaluated using critical appraisal checklists from SIGN. Meta-analyses and trial sequential analysis were performed with Review Manager v5.3 and TSA software, respectively. RESULTS: Eight RCTs on abdominal wall closure were included in the meta-analysis. In an overall comparison including both triclosan-coated Vicryl and PDS sutures for fascial closure, triclosan-coated sutures were superior in reducing the rate of SSI (OR 0.67; 0.46-0.98). When evaluating PDS sutures separately, there was no effect of triclosan-coating on the rate of SSI (OR 0.85; 0.61-1.17). Trial sequential analysis showed that the required information size (RIS) of 797 patients for triclosan-coated Vicryl sutures was almost reached with an accrued information size (AIS) of 795 patients. For triclosan-coated PDS sutures an AIS of 2707 patients was obtained, but the RIS was estimated to be 18,693 patients. CONCLUSION: Triclosan-coated Vicryl sutures for abdominal fascial closure decrease the risk of SSI significantly and based on the trial sequential analysis further RCTs will not change that outcome. There was no effect on SSI rate with the use of triclosan-coated PDS sutures for abdominal fascial closure, and it is unknown whether additional RCTs will change that.

[Clinical trials published in Revista Española de Anestesiología y Reanimación: characteristics and quality of design]. / Características y calidad metodológica de los ensayos clínicos publicados en la Revista Española de Anestesiología y Reanimación.

OBJECTIVE: To identify and assess the quality of controlled clinical trials published in Revista Española de Anestesiología y Reanimación during the period 1967-2004. MATERIAL AND METHODS: We identified and classified clinical trials following the criteria adopted by the International Cochrane Collaboration. Each trial was described and its design assessed. RESULTS: We identified 640 controlled clinical trials: 233 (36.4%) were published as original articles, 398 (62.2%) were conference presentations, and 9 (1.4%) were in other publication formats. The most common type of trial design, found in 398 (62.2%) cases, was drug-to-drug comparison. The main outcome was of clinical interest in 464 (72.5%) cases. The system of randomization used was considered adequate in only 37 (5.8%) of the studies. The funding source for 432 (67.5%) trials was not specified. CONCLUSIONS: It is noteworthy that Revista Española de Anestesiología y Reanimación has published a large number of controlled clinical trials in comparison with other Spanish journals covered by Index Medicus. We observed that important information on how the trials were carried out was missing and that trial quality was low in terms of current standards. The editorial board's adoption of the CONSORT statement may help to improve the quality of trials currently being published, and that question should be analyzed after a reasonable period of time has passed.

Características y calidad metodológica de los ensayos clínicos publicados en la Revista Española de Anestesiología y Reanimación / Clinical trials published in Revista Española de Anestesiología y Reanimación: characteristics and quality of design

OBJETIVO: Identificar, describir y evaluar la calidad de los ensayos clínicos controlados (ECCs) publicados enla Revista Española de Anestesiología y Reanimacióndurante el período 1967-2004.MATERIAL Y MÉTODOS: Identificamos y clasificamoslos ensayos clínicos controlados siguiendo los criteriosadoptados por la Colaboración Cochrane Internacional.Realizamos una descripción y evaluación de la calidadmetodológica de los mismos.RESULTADOS: Identificamos 640 ECCs, de los cuales233 (36,4%) correspondían a artículos originales, 398(62,2%) a comunicaciones a congreso y 9 (1,4%) a formatosde publicación diferentes de las característicasanteriores. El tipo de intervención más frecuentementeestudiada fue “fármaco vs. fármaco” en 398 estudios(62,2%). El resultado principal del estudio tenía interésclínico en 464 (72,5%) casos. El método de aleatorizaciónutilizado se consideró adecuado tan sólo en 37 (5,8%) delos estudios. La promoción del estudio no se especificó en432 (67,5%) casos.CONCLUSIONES: Destacamos el gran número de ECCspublicados en la Rev Esp Anestesiol Reanim con respectoa las revistas españolas indexadas en Index Medicus.Se ha observado una falta de datos relevantes sobre laejecución de los ensayos así como una baja calidad metodológicade acuerdo a los criterios actuales. El hecho deque la presente revista se haya sumado a la propuestaCONSORT, es posible que permita mejorar la calidad delos ensayos clínicos que ya se están publicando en el presente;en un período razonable será necesario su análisis (AU)

OBJECTIVE: To identify and assess the quality of controlled clinical trials published in Revista Española de Anestesiología y Reanimación during the period 1967-2004. MATERIAL AND METHODS: We identified and classified clinical trials following the criteria adopted by the International Cochrane Collaboration. Each trial was described and its design assessed. RESULTS: We identified 640 controlled clinical trials: 233 (36.4%) were published as original articles, 398 (62.2%) were conference presentations, and 9 (1.4%) were in other publication formats. The most common type of trial design, found in 398 (62.2%) cases, was drug-to-drug comparison. The main outcome was of clinical interest in 464 (72.5%) cases. The system of randomization used was considered adequate in only 37 (5.8%) of the studies. The funding source for 432 (67.5%) trials was not specified. CONCLUSIONS: It is noteworthy that Revista Española de Anestesiología y Reanimación has published a large number of controlled clinical trials in comparison with other Spanish journals covered by Index Medicus. We observed that important information on how the trials were carried out was missing and that trial quality was low in terms of current standards. The editorial board's adoption of the CONSORT statement may help to improve the quality of trials currently being published, and that question should be analyzed after a reasonable period of time has passed (AU)

Description of controlled trials published in Methods and Findings, 1979-2002.

It is thought that the controlled trial (CT) is the most adequate research method to assess a therapeutic intervention in terms of efficacy, and it also constitutes the basis for the development of systematic reviews on health interventions. To identify and obtain the majority of published CTs is not an easy task, mainly because of limitations concerning the currently available electronic sources. The aim of the present work was to identify, describe, and assess the quality of CTs published in the journal Methods and Findings in Experimental and Clinical Pharmacology (M&F). Additionally, to assess the retrievability of both methods, a search was performed in Medline (PubMed access) through the use of an optimal search strategy for CTs. A total of 189 original studies out of a total of 2796 reviewed articles met the CT criteria according to the Jadad scale score, we could hold that only 58% of the CTs were of good quality. The present work confirms, once again, the limitations of a CT search performed exclusively through Medline (sensitivity 64% and specificity 98%). In conclusion, we suggest that the journal M&F explicitly joins the International CONSORT Statement.

Self-monitoring of oral anticoagulation: a systematic review and meta-analysis.

BACKGROUND: Near-patient testing has made self-monitoring of anticoagulation with warfarin feasible, and several trials have suggested that such monitoring might be equal to or better than standard monitoring. We did a systematic review and meta-analysis of all randomised controlled trials that assessed the effects of self-monitoring or self-management (self-testing and self-dosage) of anticoagulation compared with standard monitoring. METHODS: We searched the Cochrane Register of Controlled Trials, MEDLINE, EMBASE to April 2005, and contacted manufacturers and authors of relevant studies. Outcomes analysed were: major haemorrhage, thromboembolic events, death, tests in range, minor haemorrhage, frequency of testing, and feasibility of self-monitoring. FINDINGS: We identified 14 randomised trials of self-monitoring: pooled estimates showed significant reductions in thromboembolic events (odds ratio 0.45, 95% CI 0.30-0.68), all-cause mortality (0.61, 0.38-0.98), and major haemorrhage (0.65, 0.42-0.99). Trials of combined self-monitoring and self-adjusted therapy showed significant reductions in thromboembolic events (0.27, 0.12-0.59) and death (0.37, 0.16-0.85), but not major haemorrhage (0.93, 0.42-2.05). No difference was noted in minor haemorrhage. 11 trials reported improvements in the mean proportion of international normalisation ratios in range. INTERPRETATION: Self-management improves the quality of oral anticoagulation. Patients capable of self-monitoring and self-adjusting therapy have fewer thromboembolic events and lower mortality than those who self-monitor alone. However, self-monitoring is not feasible for all patients, and requires identification and education of suitable candidates.