Intraperitoneal tension-free repair of a small midline ventral abdominal wall hernia: randomized study with a mean follow-up of 3 years.

Funding received from Cousin Biotech, Wervicq Sud, France, and CR Bard Inc., Cranston, RI. The aim of this prospective randomized study was to determine the long-term recurrence and complication rates after small abdominal wall hernia repair with two different bilayer prostheses. Hernia repair using prosthetic mesh material has become the preferred method of repair, because the recurrence rates are much lower than with conventional repair techniques. The use of a hernia bilayer patch, composite expanded polytetrafluoroethylene (ePTFE)-polypropylene, with intraperitoneal placement behind the hernia defect, through a small incision, may be efficient, safe, and cost-effective. This study is a randomized, single-institution trial, including 83 selected consecutive patients with primary (umbilical, epigastric) or incisional anterior abdominal wall defects from 2 to 5 cm. Hernia repair was performed by direct local access in ambulatory surgery; the prosthesis used was a circular bilayer with an inner face in ePTFE to avoid bowel adhesion. One group was treated with a Ventralex® Hernia Patch (Bard USA). The second group was treated with a Cabs'Air® Composite (Cousin Biotech France), which was delivered with two to four fixation sutures and a balloon to properly deploy the mesh intraperitoneally. Patients' characteristics and operative and postoperative data were prospectively collected. The primary outcome was late recurrence. Secondary outcomes included, pain, discomfort and quality of life before and after (3 months) surgery using the SF-12 questionnaire, patient-surgeon satisfaction, and early and late complications. Among 98 patients, 83 were included in the study protocol between January 2007 and August 2011. The two groups were comparable according to pre- and intraoperative data. According to surgeon experience, placement of the Cabs'Air® device was significantly faster (P = 0.01) and easier. At 3 months, there was significantly less pain and less discomfort for the Cabs'Air® group and patient satisfaction rate was higher. This was confirmed by all components of the SF-12 questionnaire. Long-term follow-up was available for 77 patients. The mean follow-up was similar for the two groups (42 months; range, 14 to 70 months). At this point, for the Ventralex® group, there were four recurrences (11.7%); one mesh infection; one small bowel obstruction; and six cases (15.7%) of severe pain resulting from a mass syndrome (shrinkage) with a sense of the presence of a foreign body. Six reoperations (15.6%) were required with explant of the prosthesis. There were no recurrences or late complications in the comparative group. The Ventralex® Hernia Patch is associated with inconsistent deployment, spreading, or shrinkage, which account for late complications and decreases the overlap, which contributes to the recurrence rate. The Cabs'Air®-associated balloon facilitates superior deployment of the prosthesis allowing for good fixation with four sutures.