RESUMO
Background: Incisional hernia (IH) after abdominal surgery is a frequent surgical complication. Risk factors associated with IH are midline incisions, patients with an abdominal aneurysm of the aorta, and high BMI. Preventive measures include the use of the small-bites suture technique and/or placing a prophylactic mesh for reinforcement of the midline closure. Although recommended for high-risk patients, many surgeons are still reluctant to place a prophylactic mesh due to related complications. To counter these concerns, new synthetic resorbable meshes are being developed, such as the Deternia Self-Gripping Resorbable Mesh ("investigational device"). However, the effectiveness of this mesh in IH prevention has not been proved. Methods: The Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS) study is a European, multicentre, prospective, single-arm study. A total of 120 patients scheduled for elective midline laparotomy, and for that reason at risk of developing IH, will be recruited in ~12 sites after informed consent. The sample size was estimated based on greater than 80% power, two-sided alpha of 0.05, an expected 12 month IH rate of 8% and a predefined performance goal of 18% (10% clinical margin). Midline incisions will be closed by the small bites closure technique with a minimum 4:1 suture-to-wound length ratio and reinforced by mesh placement in the retrorectus position. The primary outcome will be IH occurrence at 12-month postoperatively, evaluated both clinically and by ultrasound. Secondary outcomes will include mesh-related and postoperative complications, surgical characteristics, IH incidence at 2 and 3 years after surgery, and quality of life. Discussion: Currently, no conclusive evidence is available for synthetic resorbable meshes in a prophylactic setting to prevent IH. The MARS study will be the first prospective cohort study to investigate resorbable synthetic meshes and small bites closure to reduce IH incidence.
RESUMO
Background: Hernia patches for umbilical hernia repair have gained popularity due to their short operation time and ease of use. However, up to 10% re-operation and 8% recurrence rates at 2-year follow-up have been published. This retrospective cohort study presents the long-term results of the hernia patch technique for umbilical hernia repair. Methods: All adult patients who underwent a primary umbilical hernia repair at Oulu University Hospital hernia surgery units during 2014-2018 were included in the study. The primary outcome measure was recurrence rate. Secondary outcomes were complications and re-operation rate. Results: A total of 619 elective primary umbilical hernia repairs were performed during 2014-2018. The major technique used was Ventralex™ ST hernia patch repair (79.0%, 488/619) for small hernias with a mean width of 1.8 (SD 0.79) cm. Most of the patches (84.7%, 414/488) were placed in the preperitoneal space. Hernia recurrence rate of patient operated on using Ventralex™ ST hernia patch was 2.5% (12/488) during a mean follow-up time of 68 (SD 16, 43-98) months. Re-operation rate for another reason than recurrence was 1.6% (8/488). Clavien-Dindo complications ≥3 occurred in 4.1% (20/488) of cases and surgical site infection rate was 3.3% (16/488). Conclusion: Umbilical hernia repair using a Ventralex™ ST hernia patch placed in preperitoneal space have acceptable results in terms of recurrence and re-operations in this cohort study.