A new semiresorbable mesh for primary inguinal repair: a preliminary observational study on quality of life and safety

Abstract

A currently unsolved problem of open inguinal hernia repair (IHR) is chronic postoperative inguinal pain (CPIP), which affects 10-12% of patients after IHR. In the present paper, we explored the results of a newly designed partially absorbable mesh made of polypropylene and polylactic acid (HybridMesh®) for open hernia repair and its impact on postoperative safety, efficacy, comfort and pain. A prospective multicentric pilot trial was conducted in third-referral centers across Italy (n = 5). Inclusion criteria were unilateral primary inguinal hernia in patients of both genders and BMI < 30kg/m2. All patients were submitted to elective Lichtenstein mesh hernia repair under local anesthesia with HybridMesh. Primary outcome measure was the evaluation of Carolina Comfort Scale and modifications at 2years after surgery and its correlation with surgical variables; secondary outcomes were postoperative early and late morbidity, recurrence and postoperative early quality of life. Between 2015 and 2016, 125 (5 female) patients were operated, 2-year follow-up rate was 100%. The surgical site occurrence rate was 28% without the need of procedural interventions. Twenty-four months after surgery, no case of severe CPIP was recorded and altered global CCS score was present in 16 patients (13.0%). At univariate analysis, CCS score was negatively affected by fixation with sutures (OR 3.949; 95% CI 1.334-13.300), with no effect shown on multivariate analysis. Alterations in pain and movement limitations domains of CCS were observed in 9.7% of patients, at univariate analysis; they occurred more frequently when the mesh was sutured (OR 4.437; 95% CI 1.387-17.025) and in patients suffering from SSO (ecchymosis: OR 3.269; 95% CI 1.032-10.405); however, no effect was shown on multivariate analysis. Two recurrences (1.6%) were identified within the first postoperative year. The results of this study support the safety, efficacy and good tolerability of HybridMesh as a device to treat primary unilateral inguinal hernia during open anterior approach. Further studies are needed to clarify its role in comparison to currently available devices at longer follow-ups.