RESUMO
BACKGROUND: Biomaterial research has made available a biologically derived fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for use in ventral and incisional hernia repair (VIHR). This study evaluates outcomes of patients undergoing VIHR with P4HB mesh. METHODS: An IRB-approved prospective pilot study was conducted to assess clinical and quality of life (QOL) outcomes for patients undergoing VIHR with P4HB mesh. Perioperative characteristics were defined. Clinical outcomes, employment status, QOL using 12-item short form survey (SF-12), and pain assessments were followed for 24 months postoperatively. RESULTS: 31 patients underwent VIHR with bioresorbable mesh via a Rives-Stoppa approach with retrorectus mesh placement. The median patient age was 52 years, median body mass index was 33 kg/m2, and just over half of the patients were female. Surgical site occurrences occurred in 19% of patients, most of which were seroma. Hernia recurrence rate was 0% (median follow-up = 414 days). Patients had significantly improved QOL at 24 months compared to baseline for SF-12 physical component summary and role emotional (p < 0.05). CONCLUSIONS: Ventral hernia repair with P4HB bioresorbable mesh results in favorable outcomes. Early hernia recurrence was not identified among the patient cohort. Quality of life improvements were noted at 24 months versus baseline for this cohort of patients with bioresorbable mesh. Use of P4HB mesh for ventral hernia repair was found to be feasible in this patient population. (ClinicalTrials.gov Identifier: NCT01863030).
Assuntos
Hérnia Ventral/cirurgia , Herniorrafia/instrumentação , Hidroxibutiratos , Telas Cirúrgicas , Adulto , Feminino , Herniorrafia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Estudos Prospectivos , Qualidade de Vida , Resultado do TratamentoRESUMO
Acellular dermal matrices (ADMs) are used in conjunction with complex hernia repair, but their efficacy is often debated. This study assesses clinical and quality of life (QOL) outcomes in multiply comorbid patients undergoing complex ventral hernia repair using ADMs. After obtaining institutional review board approval, a prospective study was conducted evaluating patients undergoing complex ventral incisional hernia repair with abdominal wall reconstruction (AWR) using either human (Flex HD) or porcine ADM (Strattice). Patient accrual occurred over three years. Demographics, comorbid conditions, and operative details were recorded. Postoperative two-week, six-week, six-month, and one-year follow-up occurred. Primary outcomes measures include wound occurrence, QOL parameters using the Short Form-12 health survey, and hernia recurrence. Groups were compared using chi-squared, Fisher's exact, Mann-Whitney U, or t tests as appropriate. Significance was set at P < 0.05. Thirty-five patients underwent hernia repair using ADM: mean age = 58 years, mean body mass index = 34 kg/m2, >50 per cent Centers for Disease Control and Prevention Wound Class II and above, >50 per cent recurrent hernia repair, and 25 per cent current or previous mesh infection. Twenty patients (57%) experienced surgical site occurrences, 15 (43%) wound infections, and 5 (14%) recurrences with a median follow-up of one year. All Short Form-12 QOL indicators improved at 12 months compared with baseline (NS). Outcomes were similar between mesh types. In conclusion, abdominal wall reconstruction for complex hernias using biologic materials is safe but has significant morbidity. Wound complications occur in over half of all patients and are not impacted by ADM type. There is no decrement in QOL one year after hernia repair despite associated morbidity.