7 research outputs found

    Prospective, multicenter study of P4HB (Phasixâ„¢) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up

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    Background: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. Materials and methods: P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. Results: A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. Conclusions: Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing

    Weight Loss and Timing of J Tube Removal in Biliopancreatic Diversion with Duodenal Switch Patients Who Report Physical or Sexual Abuse

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    Background Bariatric surgery patients who report physical or sexual abuse form a sizeable cohort that stands out due to psychological comorbidity. Their possible vulnerability to suboptimal weight loss remains of interest. Their risk for malnutrition due to inadequate oral intake following surgery is underexplored. Objectives Study aims were to determine the effect of self-reported physical or sexual abuse in patients undergoing open biliopancreatic diversion with duodenal switch (BPD/DS) on (a) 3-year weight loss trajectories and (b) timing of feeding jejunostomy tube (J tube) removal. Delayed J tube removal served as an indicator for inadequate oral intake. Methods In this retrospective cohort study, the sample (N = 189) consisted of all patients who underwent primary BPD/DS by the same surgeon during 2009 and 2010 at a Midwestern health system. All patients had a J tube placed during surgery. Longitudinal mixed models were used for testing differences in weight loss trajectories by abuse status. Results There were no significant differences in weight loss trajectories by abuse status. The abused group had the J tube in place a mean of 61.9 days (SD = 39.5) compared to 44.8 days (SD = 32.8) for the not abused group, a significant difference. Conclusions Our use of the best available statistical methods lends validity to previous findings that suggest physical or sexual abuse does not affect weight loss after bariatric surgery. Increased likelihood of persistent inadequate oral intake in the abused group suggests the need for early multidisciplinary interventions that include mental health and nutrition experts
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