Prophylactic Mesh Reinforcement for Non-Midline Incisions: A Systematic Review.

Background: Many abdominal-pelvic surgeries utilize incisions not along the linea alba, such as transverse, laparoscopic, ostomy reversal, or ostomy formation incisions. The prevalence of ventral incisional hernias (VIH) at these sites and the efficacy of prophylactic mesh in preventing VIH remains unclear. Methods: PubMed, Embase, Scopus, and Cochrane databases were systematically reviewed from inception to September 2022. We included published randomized controlled trials (RCTs) that compared prophylactic mesh reinforcement versus no mesh. The primary outcome was the incidence of VIH at postoperative follow-up equal to or greater than 24 months. Secondary outcomes included surgical site infection (SSI) and surgical site occurrence (SSO). Results: Of 3186 screened articles, only 3 RCTs with at least an 80% 2-year follow-up, encompassing a total of 901 patients, were included for analysis of non-midline VIH. Fifteen additional RCTs were included for analysis of secondary outcomes. The rate of parastomal hernias with prophylactic mesh was 21%, while it ranged from 44%-64% in the control group. The rate of incisional hernia after ostomy reversal with prophylactic mesh was 10%, and 16% in the control group. No clear evidence of a difference was found in rates of SSI or SSO between groups. Conclusion: There is limited evidence on the role of prophylactic mesh in preventing non-midline VIH. More studies at low risk for bias are needed to elucidate the balance of the long-term risks and benefits of prophylactic mesh for non-midline incisions.

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

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.

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

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, ß = 0.20, and Δ = 20%, it was estimated that 105 patients were needed. Primary outcome was assessed using Fisher's 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.

The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases.

BACKGROUND: The vast majority of devices cleared by the Food and Drug Administration (FDA) are through the 510(k) process, which allows medical devices to be quickly introduced into the market. The FDA 510(k) process is designed to minimize the burden and expense of bringing new devices to market; however, as a result, the FDA may be limited in its ability to establish the safety of these devices. METHODS: The FDA 510(k) online archives were searched for devices cleared from 2013 to 2014. One thousand devices were randomly selected. PubMed was searched for each device to identify publications about the devices. The primary outcome was the percentage of devices cleared through the 510(k) process with no published research. Secondary outcomes included: conflict of interest (COI) of authors and outcomes of published studies on the devices. RESULTS: A total of 6152 devices were cleared through the 510(k) process in 2013-2014. Of the 1000 randomly selected devices, 17.8% had published research. There were 375 manuscripts, of which 47 (12.5%) were randomized controlled trials. One-fourth (25.1%) of studies had a clearly identifiable COI, while COI was unclear for half (49.9%). CONCLUSION AND RELEVANCE: There is limited evidence examining the safety and effectiveness of devices cleared via the 510(k) process. Thousands of devices are cleared through the FDA's 510(k) process each year with limited or no evidence publicly available. This has led to the market being introduced to potentially costly, nonbeneficial, or harmful devices. Devices, like prescription drugs, should undergo a more rigorous clearance process.

Genome Sequences of Five Streptomyces Bacteriophages Forming Cluster BG.

Cluster BG of the actinobacteriophage was formed upon discovery of five novel bacteriophages isolated by enrichment from their host, Streptomyces griseus subsp. griseus strain ATCC 10137. Four members of this cluster (BabyGotBac, Maih, TP1605, and YDN12) share over 89% average nucleotide identity, while the other (Xkcd426) has only 72% similarity to other cluster members.