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Randomized Controlled Trial
Safety and efficacy of prophylactic resorbable biosynthetic mesh following midline laparotomy in clean/contemned field: preliminary results of a randomized double blind prospective trial.
- F Pizza, D D'Antonio, M Arcopinto, C Dell'Isola, and A Marvaso.
- ASL Napoli 2 Nord, Via Lupoli, 27, 80027, Frattamaggiore, Naples, Italy. francesco_pizza@libero.it.
- Hernia. 2020 Feb 1; 24 (1): 85-92.
BackgroundIncisional hernia (IH) is one of the most common sequelae of laparotomy.Materials And MethodsWe present a double-blind randomized study examining feasibility, safety and incisional hernia rate using a prophylactic Bio-A biosynthetic stripe (Gore) in a sub-lay position after midline laparotomy in patients undergoing operations in clean-contaminated and contaminated field. One hundred patients who underwent a midline laparotomy of at least 10 cm in a clean-contaminated and contaminated field were considered. Patients were divided into two groups: [Group A closed in double layer using PDS 0 with WL/SL of 1:4; Group B closure in double layer using PDS 0 and sub-lay positioning a 3 cm-wide BIO A (Gore) strip extended for the entire length of the incision]. The primary objective of the study was to identify IH rate in the two groups at 1- and 2-year follow-up. Secondary objective was to identify any differences in the two groups in terms of post-operative pain, morbidity and mortality.ResultsOut of a total of 100 patients included in the study, a 2-year follow-up was possible for 47 patients in group A and 45 in group B. The incidence of IH was 11/47 in group A (22%) and 3/45 in group B (6%) [p < 0.01]. Furthermore, no statistically significant difference was noted about post-operative morbidity and pain related to the wall closure method.ConclusionsThe prophylactic use of a BIO-A biosynthetic stripe (Gore) showed a statistically significant reduction in the incisional hernia rate in patients who underwent clean-contaminated and contaminated surgery.
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