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A new semiresorbable mesh for primary inguinal repair: a preliminary observational study on quality of life and safety
Ist Teil von
Hernia : the journal of hernias and abdominal wall surgery, 2020-10, Vol.24 (5), p.1019-1031
Ort / Verlag
Paris: Springer Paris
Erscheinungsjahr
2020
Quelle
Alma/SFX Local Collection
Beschreibungen/Notizen
Background
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.
Methods
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 < 30 kg/m
2
. 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 2 years after surgery and its correlation with surgical variables; secondary outcomes were postoperative early and late morbidity, recurrence and postoperative early quality of life.
Results
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.
Conclusions
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.