Determining the value of the abdominal core health quality collaborative to support regulatory decisions.

PURPOSE: The study objective is to document value created by real-world evidence from the Abdominal Core Health Quality Collaborative (ACHQC) for regulatory decisions. The ACHQC is a national effort that generates data on hernia repair techniques and devices. METHODS: Two retrospective cohort evaluations compared cost and time of ACHQC analyses to traditional postmarket studies. The first analysis was based on 25 reports submitted to the European Medicines Agency of 20 mesh products for post-market surveillance. A second analysis supported label expansion submitted to the Food and Drug Administration, Center for Devices and Radiological Health for a robotic-assisted surgery device to include ventral hernia repair. Estimated costs of counterfactual studies, defined as studies that might have been done if the registry had not been available, were derived from a model described in the literature. Return on investment, percentage of cost savings, and time savings were calculated. RESULTS: 45,010 patients contributed to the two analyses. The cost and time differences between individual 25 ACHQC analyses (41,112 patients) and traditional studies ranged from $1.3 to $2.2 million and from 3 to 4.8 years, both favoring use of the ACHQC. In the second label expansion analysis (3,898 patients), the estimated return on investment ranged from 11 to 461% with time savings of 5.1 years favoring use of the ACHQC. CONCLUSIONS: Compared to traditional postmarket studies, use of ACHQC data can result in cost and time savings when used for appropriate regulatory decisions in light of key assumptions.

Prolene hernia system, ultrapro hernia system and 3D patch devices in the treatment of inguinal, femoral, umbilical and small incisional hernias in outpatient surgery.

INTRODUCTION: The employment of a diversity of prosthetic materials and several types of mesh different in construction is opening a new chapter in hernia surgery and tension-free techniques are becoming a "golden standard" for repairing abdominal wall defects, whereas the conventional methods, i.e., the tension techniques are performed on young patients having small direct, indirect, or femoral hernias. AIM: The aim of this retrospective study is to present the results of using Prolene Hernia System (PHS), Ultrapro Hernia System (UHS) and 3D Patch (3DP) devices in the treatment of inguinal, femoral, umbilical and small incisional hernias in outpatient surgery. MATERIAL AND METHODS: From January 2006 to January 2009, 70 patients were operated on for abdominal wall hernias (54 inguinal, 4 femoral, 8 umbilical and 4 small incisional hernias) using PHS, UHS and 3DP devices. All the patients underwent surgery under local infiltrative anaesthesia. All the surgical operations were performed by a single surgeon, 19 of them in the General Hospital and 51 in a private polyclinic. RESULTS: The mean size of the hernia defect in the inguinal, femoral and umbilical hernias was 2.5 cm (1-4 cm), while in the incisional hernias it was 4.5 cm (3-6 cm). The mean operating time was 2.4 hrs (2-6 hrs). There were no requirement for urinary drains. The mean follow-up was 18 months (0-36 months). The incidence of infection, chronic pain and recurrence was 0%. Three of the patients had complications: seroma in one patient with an incisional hernia and hematoma in two patients after inguinal hernia repair. CONCLUSION: The employment of PHS, UHS and 3DP devices, which have not yet been widely accepted in our hospitals, has had outstanding results in outpatient surgery. In addition, the type of anaesthesia and the 3D mesh construction prepare the way for a short hospital stay, smooth recovery and a swift return to normal activity.