Evolution of the TcPO2 values following hyperoxygenated fatty acids emulsion application in patients with diabetic foot disease: results of a clinical trial.

OBJECTIVE: The use of emollients to lubricate dry skin to prevent diabetic foot ulcers (DFUs), especially in neuroischaemic feet, has been recommended. This study analyses the effect of daily topical application of hyperoxygenated fatty acids emulsion on transcutaneous oxygen pressure (TcPO2) in the feet of neuropathic and neuroischaemic patients with diabetes. METHOD: Patients with diabetes and no active foot ulcer were included in this longitudinal, prospective, non-comparative clinical trial. The evolution of TcPO2 (mmHg) values after the application of the tested emulsion (Corpitol Emulsion, Laboratoires Urgo Medical, France) was evaluated for a three-month period. Modifications of skin features (skin dryness, skin shedding and skin colour) were also analysed. TcPO2 was performed using a TCM400 device (Radiometer, Denmark). RESULTS: A total of 50 patients were included in the study. Patients with neuroischaemia showed a significant increase in TcPO2 values (35.69±13.88mmHg) after two months' application of the tested emulsion that remained at month three (day 60: 42.34±10.98mmHg; p=0.006; day 90: 41.62±10.88mmHg; p=0.011). Skin dryness and shedding showed an improvement from baseline to the end of the study in both groups, secondary to the use of the tested emulsion (p<0.001 and p<0.001, respectively). Skin colour also showed differences from baseline to the final visit in the neuroischaemic patients (p=0.029). Patients with neuropathy did not show any change in skin colour from baseline to the final visit. CONCLUSIONS: Analysis of the use of the tested emulsion showed an increase in TcPO2 and an improvement in skin trophism in patients with neuroischaemic foot.

Metalloproteinases in chronic and acute wounds: A systematic review and meta-analysis.

A systematic review and meta-analysis were undertaken in order to explore the influence of matrix metalloproteinases and their diagnostic methods in chronic and acute wounds. Searches were conducted in the PubMed (Medline) and Embase (Elsevier) databases from inception to late November 2017. We included clinical trials enrolling patients with cutaneous chronic and acute wounds where a validated diagnostic method was employed for metalloproteinases. We excluded in vitro, animal or preclinical studies, nonoriginal articles, and studies without available data for analysis. In addition, references of narrative and systematic reviews were scrutinized for additional articles. Eight studies met the inclusion criteria. Results revealed that the most frequently determined matrix metalloproteinases were MMP-2 and MMP-9, and were found in 54.5% of wounds. MMP-9 was present in more than 50% of the chronic wounds with a range from 37 to 78%. However, metalloproteinases were found in only 20% of acute wounds, and other types of metalloproteinases were also observed (MMP-2 and MMP-3). On the basis of the available evidence, high levels of metalloproteinases have been correlated with significantly delayed wound healing in wounds of a variety of etiologies.

Quality Assessment and Risk of Bias of Systematic Reviews of Prophylactic Mesh for Parastomal Hernia Prevention Using AMSTAR and ROBIS Tools.

BACKGROUND: Systematic reviews play a crucial role in clinical decision making and resource allocation and are expected to be unbiased and consistent. The aim of this study is a review of systematic reviews on the use of prophylactic mesh to prevent parastomal hernia (PH) formation using ROBIS and AMSTAR tools to assess the risk of bias and methodological quality. METHODS: We included systematic reviews with or without meta-analysis of which the objective was to assess the use of a prophylactic mesh to prevent PH. A systematic search of the literature in five databases from inception until December 2017 was conducted. For each systematic review, methodologic quality and risk of bias were assessed using the AMSTAR and ROBIS tools, respectively. We estimated the inter-rater reliability for individual domains and for the overall methodological quality and risk of bias using Fleiss' k. RESULTS: We identified 14 systematic reviews that met the inclusion criteria. Using the AMSTAR scale with a cutoff value, six reviews showed high methodologic quality and eight were of low quality. Using the ROBIS tool, the overall risk of bias was low in 50% of the reviews analyzed. In the remaining studies, the risk of bias was unclear. CONCLUSIONS: The global evidence in favor of the use of a prophylactic mesh for preventing PH is not uniform regarding quality and risk of bias. Surgeons cannot be equally confident in the results of all systematic reviews published on this topic.

A Meta-analysis of Prophylaxis of Surgical Site Infections with Topical Application of Povidone Iodine Before Primary Closure.

BACKGROUND: Povidone iodine (PVI) is a widely used antiseptic solution among surgeons. A meta-analysis based on randomized controlled trials (RCTs) was conducted to establish whether application of PVI before wound closure could reduce surgical site infection (SSI) rates. METHODS: Systematic review of MEDLINE/PubMed, Scopus, CINAHL, and Web of Science databases from inception to September 2017, with no language restrictions. Only RCTs were retrieved. The primary outcome was the SSI rate. Meta-analysis was complemented with trial sequential analysis (TSA). RESULTS: A total of 7601 patients collected from 16 RCTs were analyzed. A reduction in overall SSI rate was found (RR 0.64, 95% CI 0.48-0.85, P = 0.002, I2 = 65%), which was attributed to patients undergoing elective operations (n = 2358) and mixed elective/urgent operations (n = 2019). When RCTs of uncertain quality (n = 9) were excluded, the use of PVI before wound closure (n = 4322 patients) was not associated with a significant reduction of SSI (RR 0.81, 95% CI 0.55-1.20, P = 0.29, I2 = 51%) and was only significant in clean wounds (RR 0.25, 95% CI 0.09-0.70, P = 0.008, I2 = 0%). For the primary outcome, the TSA calculation using a relative risk reduction of 19% and an 11% proportion of control event rate (CER) with 51% of I2, the accrued information size (n = 4322) was 32.8% of the estimated optimal information size (n = 13,148). CONCLUSIONS: There is no conclusive evidence for a strong recommendation of topical PVI before wound closure to prevent SSI.

Single-incision surgery trocar-site hernia: an updated systematic review meta-analysis with trial sequential analysis by the Minimally Invasive Surgery Synthesis of Interventions Outcomes Network (MISSION).

BACKGROUND: Single-incision laparoscopic surgery (SILS) is a new technique that aims to minimize abdominal wall trauma and improve cosmesis. Concerns have been raised about the risk of trocar-site hernia following SILS. This study aims to assess the risk of trocar-site hernia following SILS compared to conventional laparoscopic surgery, and investigate whether current evidence is conclusive. METHODS: We performed a systematic search of MEDLINE, AMED, CINAHL, CENTRAL, and OpenGrey. We considered randomized clinical trials comparing the risk of trocar-site hernia with SILS and conventional laparoscopic surgery. Pooled odds ratios with 95% confidence intervals (CI) were calculated using the Mantel-Haenszel method. Trial sequential analysis using the Land and DeMets method was performed to assess the possibility of type I error and compute the information size. RESULTS: Twenty-three articles reporting a total of 2471 patients were included. SILS was associated with higher odds of trocar-site hernia compared to conventional laparoscopic surgery (odds ratio 2.37, 95% CI 1.25-4.50, p = 0.008). There was no evidence of between-study heterogeneity or small-study effects. The information size was calculated at 1687 patients and the Z-curve crossed the O'Brien-Fleming α-spending boundaries at 1137 patients, suggesting that the evidence of higher risk of trocar-site hernia with SILS compared to conventional laparoscopic surgery can be considered conclusive. CONCLUSIONS: Single-incision laparoscopic procedures through the umbilicus are associated with a higher risk of trocar-site hernia compared to conventional laparoscopic surgery.

Self-monitoring and self-management of oral anticoagulation.

BACKGROUND: The introduction of point-of-care devices for the management of patients on oral anticoagulation allows self-testing by the patient at home. Patients who self-test can either adjust their medication according to a pre-determined dose-INR (international normalized ratio) schedule (self-management), or they can call a clinic to be told the appropriate dose adjustment (self-monitoring). Increasing evidence suggests self-testing of oral anticoagulant therapy is equal to or better than standard monitoring. This is an updated version of the original review published in 2010. OBJECTIVES: To evaluate the effects on thrombotic events, major haemorrhages, and all-cause mortality of self-monitoring or self-management of oral anticoagulant therapy compared to standard monitoring. SEARCH METHODS: For this review update, we re-ran the searches of the Cochrane Central Register of Controlled Trials (CENTRAL), 2015, Issue 6, the Cochrane Library, MEDLINE (Ovid, 1946 to June week 4 2015), Embase (Ovid, 1980 to 2015 week 27) on 1 July 2015. We checked bibliographies and contacted manufacturers and authors of relevant studies. We did not apply any language restrictions . SELECTION CRITERIA: Outcomes analysed were thromboembolic events, mortality, major haemorrhage, minor haemorrhage, tests in therapeutic range, frequency of testing, and feasibility of self-monitoring and self-management. DATA COLLECTION AND ANALYSIS: Review authors independently extracted data and we used a fixed-effect model with the Mantzel-Haenzel method to calculate the pooled risk ratio (RR) and Peto's method to verify the results for uncommon outcomes. We examined heterogeneity amongst studies with the Chi(2) and I(2) statistics and used GRADE methodology to assess the quality of evidence. MAIN RESULTS: We identified 28 randomised trials including 8950 participants (newly incorporated in this update: 10 trials including 4227 participants). The overall quality of the evidence was generally low to moderate. Pooled estimates showed a reduction in thromboembolic events (RR 0.58, 95% CI 0.45 to 0.75; participants = 7594; studies = 18; moderate quality of evidence). Both, trials of self-management or self-monitoring showed reductions in thromboembolic events (RR 0.47, 95% CI 0.31 to 0.70; participants = 3497; studies = 11) and (RR 0.69, 95% CI 0.49 to 0.97; participants = 4097; studies = 7), respectively; the quality of evidence for both interventions was moderate. No reduction in all-cause mortality was found (RR 0.85, 95% CI 0.71 to 1.01; participants = 6358; studies = 11; moderate quality of evidence). While self-management caused a reduction in all-cause mortality (RR 0.55, 95% CI 0.36 to 0.84; participants = 3058; studies = 8); self-monitoring did not (RR 0.94, 95% CI 0.78 to 1.15; participants = 3300; studies = 3); the quality of evidence for both interventions was moderate. In 20 trials (8018 participants) self-monitoring or self-management did not reduce major haemorrhage (RR 0.95, 95% CI, 0.80 to 1.12; moderate quality of evidence). There was no significant difference found for minor haemorrhage (RR 0.97, 95% CI 0.67 to 1.41; participants = 5365; studies = 13). The quality of evidence was graded as low because of serious risk of bias and substantial heterogeneity (I(2) = 82%). AUTHORS' CONCLUSIONS: Participants who self-monitor or self-manage can improve the quality of their oral anticoagulation therapy. Thromboembolic events were reduced, for both those self-monitoring or self-managing oral anticoagulation therapy. A reduction in all-cause mortality was observed in trials of self-management but not in self-monitoring, with no effects on major haemorrhage.

Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data.

BACKGROUND: Uptake of self-testing and self-management of oral anticoagulation [corrected] has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in the evidence, including an estimate of the effect on time to death, first major haemorrhage, and thromboembolism. METHODS: We searched Ovid versions of Embase (1980-2009) and Medline (1966-2009), limiting searches to randomised trials with a maximally sensitive strategy. We approached all authors of included trials and requested individual patient data: primary outcomes were time to death, first major haemorrhage, and first thromboembolic event. We did prespecified subgroup analyses according to age, type of control-group care (anticoagulation-clinic care vs primary care), self-testing alone versus self-management, and sex. We analysed patients with mechanical heart valves or atrial fibrillation separately. We used a random-effect model method to calculate pooled hazard ratios and did tests for interaction and heterogeneity, and calculated a time-specific number needed to treat. FINDINGS: Of 1357 abstracts, we included 11 trials with data for 6417 participants and 12,800 person-years of follow-up. We reported a significant reduction in thromboembolic events in the self-monitoring group (hazard ratio 0·51; 95% CI 0·31-0·85) but not for major haemorrhagic events (0·88, 0·74-1·06) or death (0·82, 0·62-1·09). Participants younger than 55 years showed a striking reduction in thrombotic events (hazard ratio 0·33, 95% CI 0·17-0·66), as did participants with mechanical heart valve (0·52, 0·35-0·77). Analysis of major outcomes in the very elderly (age ≥85 years, n=99) showed no significant adverse effects of the intervention for all outcomes. INTERPRETATION: Our analysis showed that self-monitoring and self-management of oral coagulation is a safe option for suitable patients of all ages. Patients should also be offered the option to self-manage their disease with suitable health-care support as back-up. FUNDING: UK National Institute for Health Research (NIHR) Technology Assessment Programme, UK NIHR National School for Primary Care Research.

Increasing Transcutaneous Oxygen Pressure in Patients With Neuroischemic Diabetic Foot Ulcers Treated With a Sucrose Octasulfate Dressing: A Pilot Study.

Regarding the positive clinical outcomes of sucrose octasulfate impregnated dressing documented in neuroischemic diabetic foot ulcers (DFUs), we aimed to evaluate the microcirculatory status in patients with neuroischemic DFU through the use of sucrose octasulfate dressing. Eleven patients with neuroischemic DFU were included in a prospective pilot study between July 2019 and March 2020. We evaluated the effect in transcutaneous oxygen pressure (TcPO2; mm Hg) values within the use of a sucrose octasulfate dressing in the course of the healing process of neuroischemic DFUs (UrgoStart Contact, Laboratoires Urgo Medical). TcPO2 values were assessed at day 0 and monthly until wound healing was achieved. Additionally, wound healing process was evaluated using the Wollina score system and wound area surface, at day 0 and monthly until 20 weeks of follow-up or wound healing first occurred. TcPO2 values showed a significant increase between day 0 (29.45 ± 7.38 mm Hg) and wound closure (46.54 ± 11.45 mm Hg, P = .016), after dressing application. Wollina wound scores showed a significant improvement (4.2 ± 1.7 at day 0 to 5.4 ± 1.3 at the end of the study; P = .004). Median wound area at day 0 was 1.30 cm2, interquartile range [1.60-1] cm2, and 0.5 cm2 at week 4, interquartile range [1.1-0.1], P < .001. Median healing time was 8 weeks, interquartile range [8-5]. Treating a neuroischemic DFU with a sucrose octasulfate dressing in the standard of care showed an increase in skin oxygen pressure.

[Epidemiological aspects, clinic and control mechanisms of SARS-CoV-2 pandemic: Situation in Spain]. / Aspectos epidemiológicos, clínica y mecanismos de control de la pandemia por SARS-CoV-2: situación en España.

In January 2020, the Chinese authorities confirmed the causative agent of an outbreak of cases with pneumonia of unknown etiology that appeared in December 2019. The World Health Organization (WHO) called SARS-CoV-2 is a new virus of the coronavirus family. On March 12, the WHO declared this outbreak as a pandemic as it spread worldwide. Human epidemics usually follow the start of exponential growth, this means that from a small number of cases in a few days, a large increase in the number of infected people is observed. The clinical manifestations and spectrum of symptomatic disease range from moderate to critical presentations. In cases with fatal progression, the most serious complications sometimes are cause of a multi-organ failure and patient death. SARS-CoV-2 has a high transmission rate, the route of transmission between humans is through the secretions of infected people, hands or contaminated objects. In general, the epidemic control measures used so far have been based on adoption of interventions from the classical epidemiology, identifying and isolating the cases, following the contacts and establishing restrictions, including quarantine, closure of educational centers, avoiding events in which crowds of people occur, limiting mobility. These measures have been effective in China, the original focus of the outbreak.

Medical Versus Surgical Treatment for the Management of Diabetic Foot Osteomyelitis: A Systematic Review.

A systematic review and quality assessment was performed to assess the management of diabetic foot osteomyelitis by medical or surgical treatment. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was used. All selected studies were evaluated using the Cochrane Risk of Bias Tool to assess the risk of bias for randomized controlled trials. The literature was revised using PubMed (Medline) and Embase (Elsevier) up to September 2020 to identify clinical trials assessing medical or surgical treatment to manage diabetic foot osteomyelitis. A total of six clinical trials that met our inclusion criteria, with a total of 308 participants. Healing rate, complete closure of the wound, and type of complications were the outcomes evaluated. Risk of bias assessment showed that only two of the six clinical trials included in the systematic review had a low risk of bias. Based on our findings, we believe that the management of diabetic foot osteomyelitis remains challenging. There are few high-quality clinical trials that both stratify clinical presentations and compare these treatments. We conclude that the available evidence is insufficient to identify the best option to cure diabetic foot osteomyelitis.

Self-monitoring and self-management of oral anticoagulation.

BACKGROUND: The introduction of portable monitors (point-of-care devices) for the management of patients on oral anticoagulation allows self-testing by the patient at home. Patients who self-test can either adjust their medication according to a pre-determined dose-INR schedule (self-management) or they can call a clinic to be told the appropriate dose adjustment (self-monitoring). Several trials of self-monitoring of oral anticoagulant therapy suggest this may be equal to or better than standard monitoring. OBJECTIVES: To evaluate the effects of self-monitoring or self-management of oral anticoagulant therapy compared to standard monitoring. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 4), MEDLINE, EMBASE and CINAHL (to November 2007). We checked bibliographies and contacted manufacturers and authors of relevant studies. No language restrictions were applied. SELECTION CRITERIA: Outcomes analysed were thromboembolic events, mortality, major haemorrhage, minor haemorrhage, tests in therapeutic range, frequency of testing, and feasibility of self-monitoring and self-management. DATA COLLECTION AND ANALYSIS: The review authors independently extracted data. We used a fixed-effect model with the Mantzel-Haenzel method to calculate the pooled risk ratio (RR) and Peto's method to verify the results for uncommon outcomes. We examined heterogeneity amongst studies with the Chi(2) and I(2) statistics. MAIN RESULTS: We identified 18 randomized trials (4723 participants). Pooled estimates showed significant reductions in both thromboembolic events (RR 0.50, 95% CI 0.36 to 0.69) and all-cause mortality (RR 0.64, 95% CI 0.46 to 0.89). This reduction in mortality remained significant after the removal of low-quality studies (RR 0.65, 95% CI 0.46 to 0.90). Trials of self-management alone showed significant reductions in thromboembolic events (RR 0.47, 95% CI 0.31 to 0.70) and all-cause mortality (RR 0.55, 95% CI 0.36 to 0.84); self-monitoring did not (thrombotic events RR 0.57, 95% CI 0.32 to 1.00; mortality RR 0.84, 95% CI 0.50 to 1.41). Self-monitoring significantly reduced major haemorrhages (RR 0.56, 95% CI 0.35 to 0.91) whilst self-management did not (RR 1.12, 95% CI 0.78 to 1.61). Twelve trials reported improvements in the percentage of mean INR measurements in the therapeutic range. No heterogeneity was identified in any of these comparisons. AUTHORS' CONCLUSIONS: Compared to standard monitoring, patients who self-monitor or self-manage can improve the quality of their oral anticoagulation therapy. The number of thromboembolic events and mortality were decreased without increases in harms. However, self-monitoring or self-management were not feasible for up to half of the patients requiring anticoagulant therapy. Reasons included patient refusal, exclusion by their general practitioner, and inability to complete training.

Systematic reviews with meta-analysis of clinical trials: Is there enough evidence? / Revisiones sistemáticas con metaanálisis de ensayos clínicos: ¿es evidencia suficiente?

Systematic reviews with meta-analysis are essential tools to reliably summarize the effectiveness of health interventions. A meta-analysis based exclusively on a small number of trials will often not be conclusive or may yield false positive results. The estimation of the optimal information size (OIS) can reduce the risk of obtaining false positive results and determine if additional clinical trials are required. The estimation of the OIS is very similar to that used to estimate the sample size of a clinical trial. The required number of participants for the meta-analysis should be at least as large as a single trial with adequate power. The OIS concept provides a statistical framework in which the accumulated information is convincing to indicate whether more clinical trials are needed to address the effects of the intervention.

Metatarsal Head Resections in Diabetic Foot Patients: A Systematic Review.

A systematic review and proportional meta-analysis were carried out to investigate the complications that occur after surgical metatarsal head resection in diabetic foot patients. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist recommendations were applied, and the selected studies were evaluated using a Strengthening the Reporting of Observational studies in Epidemiology (STROBE) checklist. PubMed (Medline) and Embase (Elsevier) were searched in December 2019 to find clinical trials, cohort studies, or case series assessing the efficacy of the metatarsal head resection technique in diabetic foot patients. The systematic review covered 21 studies that satisfied the inclusion criteria and included 483 subjects. The outcomes evaluated were the time to heal, recurrence, reulceration, amputation, and other complications. The proportion of recurrence was 7.2% [confidence interval (CI) 4.0-10.4, p < 0.001], that of reulceration was 20.7% (CI 11.6-29.8, p < 0.001), and that of amputation was 7.6% (CI 3.4-11.8, p < 0.001). A heterogeneity test indicated I2 = 72.6% (p < 0.001) for recurrences, I2 = 94% (p < 0.001) for reulcerations, and I2 = 79% (p < 0.001) for amputations. We conclude that metatarsal head resections in diabetic foot patients are correlated with significant complications, especially reulceration.

[Abdominal Wall Surgery After SARS-CoV-2: Time to Reestablish Postponed Non-essential Procedures?] / Cirugía de la pared abdominal después del SARS-CoV-2: ¿es hora de restablecer los procedimientos no esenciales pospuestos?

Pandemic by the COVID-19 has found us unprotected to provide an adequate and rapid sanitary response. The hospital network of our public health system has provided most of the resources for the treatment of patients affected by the infection. Non-essential (non-priority) surgeries have been postponed. The optimal and proportionate reestablishment of these non-priority surgeries can be a problem. This article offers a technical and non-technical view of reestablishment non-priority surgeries from the perspective of abdominal wall surgery.

Practice Patterns and Attitudes of Surgeons on the Use of Prophylactic Mesh to Prevent Parastola Hernia: A Cross-sectional Survey.

Information about surgeons' attitudes toward using prophylactic mesh (PM) for parastomal hernia (PSH) prevention is limited. PURPOSE: A survey was conducted to assess attitudes/beliefs and surgical practice related to PM use for preventing PSH. METHODS: A cross-sectional email survey was conducted during April 2017 among members (surgeons) of the American Hernia Society, European Hernia Society, and International Hernia Collaboration. Survey items included participant demographic characteristics, knowledge about the incidence of PSH, number of permanent stomas created annually, beliefs/opinions (knowledge/interest) regarding the use of PM, and surgical practices (mesh type and position). Data were collected and tallied using SurveyMonkey. Descriptive statistics were used to analyze the data. RESULTS: Of the 5445 emails sent, 497 responses were received, 235 (47.3%) from the United States and 197 (39.6%) from Europe. The majority of participants were general surgeons (371, 74.6%); a small percentage were colorectal surgeons (37, 7.4%). Most respondents (353, 71.0%) reported at least 11 years of surgical experience, with 37.3% reporting >20 years' experience. The majority of respondents (340, 68.4%) created <15 ostomies per year, more than half (252, 50.7%) consider the incidence of PSH 30% or below, and 107 (22%) use PM. The most common reason for not using mesh was concern about mesh-related complications (141, 41.5%). When asked about type of mesh, most surgeons (153/245, 62.4%) preferred permanent mesh and an open retromuscular approach (97/278, 34.9%). CONCLUSION: Results of the present survey show ongoing ambiguity regarding the use of PM for PSH prevention. Education to increase awareness about the incidence of PSH and well-designed safety and effectiveness studies of preventive strategies are needed to help surgeons optimize PSH prevention strategies.

Balancing mesh-related complications and benefits in primary ventral and incisional hernia surgery. A meta-analysis and trial sequential analysis.

BACKGROUND: Primary ventral hernia (PVH) and incisional hernia (IH) repair using a mesh appears to reduce hernia recurrence. However, are the benefits of mesh offset in part by mesh-related complications? The aim of this study was to compare placement of a mesh versus simple suture for recurrence and postoperative complications in the repair of PVH or IH. METHODS: Five databases were searched for randomized controlled trials (RCTs). The study population was patients with a PVH or IH undergoing hernia repair. Intervention was placement of a nonabsorbable synthetic mesh, regardless of mesh location, surgical technique, hernia characteristics or surgical setting compared to primary suture. Primary outcome was the incidence of hernia recurrence. Secondary outcomes were wound infection, hematoma, seroma, postsurgical pain, duration of operation, and quality of life. A random-effects meta-analysis with trial sequential analysis (TSA) was used. RESULTS: 10 RCTs with a total of 1270 patients were included. A significant reduction of the incidence of PVH or IH recurrence using a mesh for repair (risk ratio [RR] 0.39, 95% CI 0.27-0.55; P < 0.00001; I2 = 20%) was observed. TSA for recurrence, the accrued information size (1270) was 312% of the estimated required information size (RIS). Subgroup analysis for PVH and IH confirms reduction of recurrence after using a mesh in both groups. Overall postoperative complications did not show statistically significant differences between the mesh and surgical suture groups (RR 1.31, 95% CI 0.94-1.84; P = 0.12; I2 = 27%) but the accrued information size was only 22.4% of RIS and by subgroups complications were only related with IH repair. CONCLUSIONS: Evidence for the efficacy of repair of PVH or IH using a nonabsorbable synthetic mesh in terms of recurrence was found to be robust. Evidence for complications remains inconclusive.