Mena Boules, MD, Ricard Corcelles, MD, PhD, Ramona Ilie, MD, Connor Wathen, BS, Andrea Zelisko, MD, Dvir Froylich, MD, Kevin El-Hayek, MD, John Rodriguez, MD, Stacy Brethauer, MD, Steven Rosenblatt, MD, Matthew Kroh, MD. Cleveland Clinic
Ventral hernia repair (VHR) is a common procedure, which continues to challenge general surgeons due to the complexity of repair. Outcomes of VHR are attributed to multifactorial characteristics including but not limited to the patients co-morbid disease, surgical approach, and material used for closure of the defect. This study aims to evaluate the outcomes and utilization of a specific porcine dermis collagen implant (PDCI) (Permacol®) during VHR. To the best of our knowledge, this is the largest retrospective single institutional study evaluating this implant to date.
Records of 5485 patients that underwent VHR repairs from June 1995 to August 2014 were analyzed retrospectively. Data collected included baseline patient demographics, peri-operative parameters, surgical approach, additional procedures during VHR, post-operative complications, recurrence rates, and follow-up time. Parameters were analyzed using paired and unpaired students t-test for continuous variables and Chi-square test for categorical variables. Uni- and multivariate analyses were used to assess the risk factors for ventral hernia recurrence after PDCI.
361 patients were identified to have received PDCI for VHR during the 9-year study period. The cohort had a male-to-female ratio of 164:197, mean age of 56.7±12.5 years; mean body mass index (BMI) of 33.0±9.9 kg/m2. American Society of Anesthesiologist (ASA) classification of the patients’ distribution was: class I (1.3%), class II (29.6%), class III (61.7%) and class IV (7.5%). At baseline, a total of 179 (49.5%) had hypertension (HTN), 88 (24.3%) diabetes, 59 (16.3%) were under immunosuppressive or steroids treatment, 52 (14.4%) had coronary artery disease (CAD), 35 (9.6%) chronic pulmonary obstructive disease (COPD), and 75 (20.7%) were active smokers. Primary VHR with PDCI was performed in 210 patients (58.1%), while recurrent repair was performed in 151 patients (41.9%). Additionally, the mean number of previous VHR was 0.4±0.5 (range 0-5). Open surgery was performed in 347 (96.1%) patients. PDCI surgical placement method was onlay (n=76, 21.0%), sublay/underlay (n=256, 70.9%), inlay (n=26, 7.2%), and not specified (n=3, 0.8%). Component separation technique was reported in 148 (40.9%) patients. Mean PDCI size was 297.7±180.7 cm2. Concomitant surgical procedures were performed in 173 (47.9%) patients and included; colorectal (n=47), stoma related (n=30), both (colorectal and stoma, n=32), and others (n=64). Mean operative time and estimated blood loss was 244.4±129.0 minutes and 274.2±384.1 mL, respectively. Early post-operative complications (first 30 days) were reported in 141 (39.0%) of patients, with wound infection (26.9%), seroma (13.4%), and postoperative ileus (12.7%) as the most frequent. The re-operation rate less than 30 days was 3.3% (n=12). After 16.3±20.3 (max: 105) months follow-up, hernia recurrence was documented in 63 (17.4%) of the 361 patients. Multivariate regression analysis of all variables confirmed age (p=0.05), male gender (p=0.04), and reoperation at first 30 days (p=0.02) as predictive factors of recurrence.
PDCI surgical implant is a relatively safe alternative in VHRs in patients undergoing concomitant surgical procedures. Age, male gender, and re-operation during the first 30 days, should be considered as predictors of recurrence.