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result(s) for
"García-Alamino, Josep M"
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Balancing mesh-related complications and benefits in primary ventral and incisional hernia surgery. A meta-analysis and trial sequential analysis
by
López-Cano, Manuel
,
Pereira, José Antonio
,
Armengol-Carrasco, Manuel
in
Abdomen
,
Biology and Life Sciences
,
Clinical trials
2018
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.
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.
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.
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.
Journal Article
A Meta-analysis of Prophylaxis of Surgical Site Infections with Topical Application of Povidone Iodine Before Primary Closure
by
López-Cano, Manuel
,
Balibrea, José
,
Curell, Anna
in
Abdominal Surgery
,
Cardiac Surgery
,
Clinical trials
2019
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,
I
2
= 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,
I
2
= 51%) and was only significant in clean wounds (RR 0.25, 95% CI 0.09–0.70,
P
= 0.008,
I
2
= 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
I
2
, 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.
Journal Article
Medical Versus Surgical Treatment for the Management of Diabetic Foot Osteomyelitis: A Systematic Review
by
Lázaro-Martínez, José Luis
,
Tardáguila-García, Aroa
,
Sanz-Corbalán, Irene
in
Amputation
,
Antibiotics
,
Bias
2021
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.
Journal Article
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)
by
Emmanuel, Klaus
,
Granderath, Frank A
,
García-Alamino, Josep M
in
Hernias
,
Laparoscopy
,
Meta-analysis
2018
BackgroundSingle-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.MethodsWe 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.ResultsTwenty-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.ConclusionsSingle-incision laparoscopic procedures through the umbilicus are associated with a higher risk of trocar-site hernia compared to conventional laparoscopic surgery.
Journal Article
Quality Assessment and Risk of Bias of Systematic Reviews of Prophylactic Mesh for Parastomal Hernia Prevention Using AMSTAR and ROBIS Tools
by
López-Cano, Manuel
,
Kroese, Leonard
,
Helgstrand, Frederik
in
Abdominal Surgery
,
Bias
,
Cardiac Surgery
2019
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.
Journal Article
Metatarsal Head Resections in Diabetic Foot Patients: A Systematic Review
by
Lázaro-Martínez, José Luis
,
Tardáguila-García, Aroa
,
Sanz-Corbalán, Irene
in
Amputation
,
Clinical medicine
,
Clinical trials
2020
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.
Journal Article
Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data
by
Ward, Alison
,
Perera, Rafael
,
Heneghan, Carl
in
Administration, Oral
,
adverse effects
,
Anticoagulants
2012
Uptake of self-testing and self-management of oral coagulation 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.
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.
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.
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.
UK National Institute for Health Research (NIHR) Technology Assessment Programme, UK NIHR National School for Primary Care Research.
Journal Article
Impact of heterogeneity and effect size on the estimation of the optimal information size: analysis of recently published meta-analyses
by
Garcia-Alamino, Josep M
,
Pidduck, Nicola
,
Perera, Rafael
in
Anticoagulants
,
Bias
,
Chemotherapy
2017
ObjectiveTo estimate the proportion of systematic reviews that meet the optimal information size (OIS) and assess the impact heterogeneity and effect size have on the OIS estimate by type of outcome (eg, mortality, semiobjective or subjective).MethodsWe carried out searches of Medline and Cochrane to retrieve meta-analyses published in systematic reviews from 2010 to 2012. We estimated the OIS using Trial Sequential Analysis software (TSA V.0.9) and based on several heterogeneity and effect size scenarios, stratifying by type of outcome (mortality/semiobjective/subjective) and by Cochrane/non-Cochrane reviews.ResultsWe included 137 meta-analyses out of 218 (63%) potential systematic reviews (one meta-analysis from each systematic review). Of these reviews, 83 (61%) were Cochrane and 54 (39%) non-Cochrane. The Cochrane reviews included a mean of 6.5 (SD 6.1) studies and the non-Cochrane included a mean of 13.2 (SD 10.2) studies. The mean number of patients was 2619.1 (SD 6245.8 or median 586.0) for the Cochrane and 19 888.5 (SD 32 925.7 or median 6566.5) patients for the non-Cochrane reviews. The percentage of systematic reviews that achieved the OIS for all-cause mortality outcome were 0% Cochrane and 25% for non-Cochrane reviews; for semiobjective outcome 17% for Cochrane and 46% for non-Cochrane reviews and for subjective outcome 45% for Cochrane and 72% for non-Cochrane reviews.ConclusionsThe number of systematic reviews that meet an optimal information size is low and varies depending on the type of outcome and the type of publication. Less than half of primary outcomes synthesised in systematic reviews achieve the OIS, and therefore the conclusions are subject to substantial uncertainty.
Journal Article