Project description:BackgroundThis prospective, multicenter, single-arm, open-label study evaluated P4HB-ST mesh in laparoscopic ventral or incisional hernia repair (LVIHR) in patients with Class I (clean) wounds at high risk for Surgical Site Occurrence (SSO).MethodsPrimary endpoint was SSO requiring intervention <45 days. Secondary endpoints included: surgical procedure time, length of stay, SSO >45 days, hernia recurrence, device-related adverse events, reoperation, and Quality of Life at 1, 3, 6, 12, 18, and 24-months.Results120 patients (52.5% male), mean age of 55.0 ± 14.9 years, and BMI of 33.2 ± 4.5 kg/m2 received P4HB-ST mesh. Patient-reported comorbid conditions included: obesity (86.7%), active smoker (45.0%), COPD (5.0%), diabetes (16.7%), immunosuppression (2.5%), coronary artery disease (7.5%), chronic corticosteroid use (2.5%), hypoalbuminemia (0.8%), advanced age (10.0%), and renal insufficiency (0.8%). Hernia types were primary ventral (44.2%), primary incisional (37.5%), recurrent ventral (5.8%), and recurrent incisional (12.5%). Patients underwent LVIHR in laparoscopic (55.8%) or robotic-assisted cases (44.2%), mean defect size 15.7 ± 28.3 cm2, mean procedure time 85.9 ± 43.0 min, and mean length of stay 1.0 ± 1.4 days. There were no SSOs requiring intervention beyond 45 days, n = 38 (31.7%) recurrences, n = 22 (18.3%) reoperations, and n = 2 (1.7%) device-related adverse events (excluding recurrence).ConclusionP4HB-ST mesh demonstrated low rates of SSO and device-related complications, with improved quality of life scores, and reoperation rate comparable to other published studies. Recurrence rate was higher than expected at 31.7%. However, when analyzed by hernia defect size, recurrence was disproportionately high in defects ≥7.1 cm2 (43.3%) compared to defects <7.1 cm2 (18.6%). Thus, in LVIHR, P4HB-ST may be better suited for small defects. Caution is warranted when utilizing P4HB-ST in laparoscopic IPOM repair of larger defects until additional studies can further investigate outcomes.
| S-EPMC8689054 | biostudies-literature
Project description:Importance:Ventral and incisional hernia repair (VIHR) is an extremely common operation, after which complications are also fairly common. A number of preoperative risk factors are known to contribute to increased complications after surgical repair; however, the individual relative association of these risk factors with adverse outcomes and increased spending is unclear. Quantifying the association of individual risk factors may help surgeons implement targeted surgical optimization, improve outcomes, and reduce spending. Objective:To identify the attributable association of modifiable risk factors for adverse outcomes after VIHR on outcomes and episode-of-care payments. Design, Setting, and Participants:This cross-sectional study was performed using a population-based sample of adult patients and episode spending data from January 1, 2012, to December 31, 2018, from a statewide multipayer registry. A multilevel mixed-effects logistic regression model was used to examine the contribution of patient-specific risk factors to adverse outcomes. Attributable risk and population attributable risk fraction were calculated to estimate the additional spending attributable to individual risk factors. Data were analyzed from April 2018 to September 2018. Main Outcomes and Measures:Any complications, serious complication, discharge not to home, 30-day emergency department utilization, and 30-day readmission. Episode-of-care spending was calculated for these outcomes. Results:This study included 22 664 patients (median [interquartile range] age, 55 [44-64] years; 10 496 [46.3%] women) undergoing VIHR with identified significant preoperative risk factors. Fourth-quartile body mass index (BMI), calculated as weight in kilograms divided by height in meters squared and defined as a mean (SD) BMI of 43 (6), was associated with increased risk of any complication (odds ratio [OR], 1.64; 95% CI, 1.30-2.06; P < .001) and serious complication (OR, 1.67; 95% CI, 1.22-2.31; P = .002). Insulin-dependent diabetes was associated with increased risk of any complication (OR, 1.34; 95% CI, 1.03-1.73; P = .03), serious complication (OR, 1.51; 95% CI, 1.08-2.12; P = .02), discharge not to home (OR, 1.49; 95% CI, 1.12-1.98; P = .005), and 30-day readmission (OR, 1.68; 95% CI, 1.32-2.14; P < .001). Median (interquartile range) additional episode spending for any complication was $9934 ($9224-$11 851), of which $1304 ($1208-$1552) was attributable to fourth-quartile BMI. Median (interquartile range) additional episode spending for a serious complication was $26 648 ($20 632-$33 166), of which $3638 ($2827-$4544) was attributable to fourth-quartile BMI, $650 ($495-$796) was attributable to insulin-dependent diabetes, and $567 ($433-$696) was attributable to unhealthy alcohol use. Conclusions and Relevance:In this cross-sectional study, modifiable risk factors, such as obesity, insulin-dependent diabetes, and unhealthy alcohol use, were associated with adverse outcomes after VIHR. These factors were significantly associated with increased health care spending; therefore, preoperative optimization may improve outcomes and decrease episode-of-care costs.
| S-EPMC6902835 | biostudies-literature