3 research outputs found

    Hernia Prevention Using Biologic Mesh and/or Small Bites: A Multispecialty 2 × 2 Factorial Randomized Controlled Trial

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    BACKGROUND: Ventral incisional hernias are the most common complication after abdominal operation. Randomized trials have shown efficacy of prophylactic synthetic mesh and small bites. Adoption of these practices has been limited due to concerns with placement of synthetic mesh in contaminated cases and small bites in an overweight population. We sought to assess the efficacy of prophylactic biologic mesh and small bites to prevent postoperative major complications: ventral incisional hernias, surgical site infection, reoperation, and death. STUDY DESIGN: High-risk patients (overweight/obese, current smoker) undergoing abdominal operation with a midline incision (5 cm or greater) were randomized (2 × 2 factorial trial) to receive either sublay biologic mesh or no mesh and either small bites (0.5 × 0. 5cm) or large bites (1 × 1 cm) fascial closure. The primary outcome measure was major complications at 1 year postoperative. CONSORT guidelines were followed, and this study was registered on clinicaltrials.gov (NCT03148496). Assuming α = 0.05, β = 0.20, and Δ = 20%, it was estimated that 105 patients were needed. Primary outcome was assessed using Fisher\u27s exact test. RESULTS: A total of 107 patients were randomized: 52 (49%) to mesh, 55 (51%) to no mesh, 55 (51%) to small bites, and 52 (49%) to large bites. Of the patients, 16% were smokers, 31% were overweight, and 55% were obese. At 1 year postoperative, there were no differences in major complications between groups (mesh vs no mesh 21% vs 16%, p = 0.62; small vs large bites 18% vs 19%, p = 1.00). CONCLUSIONS: In this trial, biologic mesh and small bites appear to have no benefit. Further randomized trials are needed among high-risk patients before widespread adoption of prophylactic biologic mesh or small bites

    Adequate Reporting Among Ventral Hernia Repair Operative Reports: A Cross-Sectional Study of Prevalence of Details and Association With Clinical Outcomes

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    Objective:. We aimed to evaluate the prevalence of highly detailed ventral hernia repair (VHR) operative reports and associations between operative report detail and postoperative outcomes in a medico-legal dataset. Background:. VHR are one of the most common surgical procedures performed in the United States. Previous work has shown that VHR operative reports are poorly detailed, however, the relationship between operative report detail and patient outcomes is unknown. Methods:. This is a retrospective cross-sectional observational study. Operative reports describing VHR were obtained from a medical-legal database. Medical records were screened and data was extracted including clinical outcomes, such as surgical site infection (SSI), hernia recurrence, and reoperation and the presence of key details in each report. Highly detailed operative reports were defined as having 70% of recommended details. The primary outcome was the prevalence of highly detailed VHR operative reports. Results:. A total of 1011 VHR operative reports dictated by 693 surgeons across 517 facilities in 50 states were included. Median duration of follow-up was 4.6 years after initial surgery. Only 35.7% of operative reports were highly detailed. More recent operative reports, cases with resident involvement, and contaminated procedures were more likely to be highly detailed (all P < 0.05). Compared to poorly detailed operative reports, cases with highly detailed reports had fewer SSIs (13.2% vs 7.5%, P = 0.006), hernia recurrence (65.8% vs 55.4%, P = 0.002), and reoperation (78.9% vs 62.6%, P = 0.001). Conclusions:. In this medico-legal dataset, most VHR operative reports are poorly detailed while highly detailed operative reports were associated with lower rates of complications. Future studies should examine a nationally representative dataset to validate our findings
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