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Abstract Objective: To describe and demonstrate the safety and efficacy of an OcluPad (OP) that closes surgical incisions in the abdominal wall, made with trocars in laparoscopic surgery in obese patients, avoiding hernias. Material and methods: After preclinical studies in rats and pigs, we obtained authorization from the Research, Ethics, and Biosafety commissions of the "20 de Noviembre" National Medical Center to develop a clinical trial and apply the OP device to 40 of the 80 patients subjected to Gastric bypass or gastric sleeve surgery as a surgical treatment for morbid obesity. The patients were divided into two groups: Group I, 40 patients with three OP devices applied to close the trocar holes, and Group II, 40 patients without surgical closure of the three trocar holes. Results: The groups were evaluated two years after the bariatric surgery procedure using abdominal tomography. Obtaining zero hernias in group I and 14 hernias in group II generated a 35% prevalence. (p = 0.001) (OR = 0.04) CI = 0.005–0.38. Conclusions: OP is a device that prevents the formation of trocar hernias in obese patients. It is efficient, simple, quick to apply, economical, and meets the concept of safety and effectiveness since it has excellent biocompatibility; generating a layer of neo-mesothelium induces minimal adhesions.
Padilla et al. (2024) studied this question.