Abstract
BackgroundIncisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients.MethodsA total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site Occurrence (SSO) including hematoma, seroma, infection, dehiscence and fistula formation (requiring intervention) through 3 months. Secondary outcomes include recurrence, infection and quality of life related outcomes after 24 months. Follow-up visits will be at drain removal (if drains were not placed, then on discharge or staple removal instead) and in the 1st, 3rd, 6th, 12th, 18th and 24th month after surgery.ConclusionBased on evidence from this clinical study Depending on the results this clinical study will yield, Phasix™ Mesh may become a preferred treatment option in VHWG Grade 3 patients.Trial registrationThe trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042.
Highlights
Incisional heia is a frequent complication of midline laparotomy
Incisional hernia (IH) is one of the most frequent complications after midline laparotomy, with incidences varying from 10 to 20%, and even higher percentages occur in high-risk groups [1, 2]
Either open or laparoscopic, lead to fewer recurrences compared to primary repair; recurrences after mesh are 7.7% compared to 23.8% after primary closure [1, 3, 9, 10]
Summary
Incisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. PhasixTM Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh This multi-center single-arm study aims to collect data on safety and performance of PhasixTM Mesh in Grade 3 hernia patients. Due to the high IH incidence rates, hernia repair surgery is one of the most frequently performed surgical procedures [5]. Despite reducing hernia recurrence rates, the use of synthetic mesh has been associated with complications in approximately 17% of patients. These complications include infection, pain, adhesions, fistulae and foreign body reactions including increased inflammation and/or connective tissue deposition [3, 11]. Complex and large abdominal wall defects continue to pose a challenge to surgeons, which are associated with recurrence rates of up to nearly 40% [12]
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