PURPOSE: To compare the results of conventional Lichtenstein hernioplasty with polypropylene mesh (PLP) with a lightweight self-adhesive mesh (Parietene Progrip®; Covidien, Dublin, Ireland) (PPG) used in patients with bilateral inguinal hernia. METHODS: Randomised clinical trial with 89 patients with a minimum follow-up of 1 year. Every patient had bilateral inguinal hernia and had both prostheses implanted randomly, one on each side. Early postoperative and chronic pain was evaluated using the visual analogue scale. Also recurrence rate and subjective evaluation of patients were analysed. RESULTS:Pain in the early postoperative period was inferior on the side where the self-adhesive mesh had been implanted (6.12 vs. 6.62, p=0.005 during the 1st postoperative day; 2.12 vs. 2.62, p=0.001 during the 7th postoperative day). Differences disappeared with the long-term evaluation (0.71 vs. 0.98, p=0.148 1 year after the surgery). The operative time was significantly shorter on the PPG mesh side (24.37 ± 5.1 in case of the PPG mesh and 29.66 ± 5.6 in case of the PLP mesh, p<0,001). Recurrence occurred in seven patients (7.8%), six of them (6.7%, CI 3.0-14.4) on the PPG mesh side and one (1.1%, CI 0.2-7.8) on the PLP side. These differences were not statistically significant (p=0.125) CONCLUSIONS: Although hernioplasty with self-adhesive mesh reduced early postoperative pain, this reduction was clinically irrelevant and it had no influence on chronic pain. There was a trend towards a higher recurrence rate when self-adhesive meshes were used, and although in this study differences were not statistically significant they should be confirmed in later studies using larger samples. Surgical procedures that do not need fixing sutures are promising, but further studies are needed before they become the gold standard of inguinal hernia repair.
RCT Entities:
PURPOSE: To compare the results of conventional Lichtenstein hernioplasty with polypropylene mesh (PLP) with a lightweight self-adhesive mesh (Parietene Progrip®; Covidien, Dublin, Ireland) (PPG) used in patients with bilateral inguinal hernia. METHODS: Randomised clinical trial with 89 patients with a minimum follow-up of 1 year. Every patient had bilateral inguinal hernia and had both prostheses implanted randomly, one on each side. Early postoperative and chronic pain was evaluated using the visual analogue scale. Also recurrence rate and subjective evaluation of patients were analysed. RESULTS:Pain in the early postoperative period was inferior on the side where the self-adhesive mesh had been implanted (6.12 vs. 6.62, p=0.005 during the 1st postoperative day; 2.12 vs. 2.62, p=0.001 during the 7th postoperative day). Differences disappeared with the long-term evaluation (0.71 vs. 0.98, p=0.148 1 year after the surgery). The operative time was significantly shorter on the PPG mesh side (24.37 ± 5.1 in case of the PPG mesh and 29.66 ± 5.6 in case of the PLP mesh, p<0,001). Recurrence occurred in seven patients (7.8%), six of them (6.7%, CI 3.0-14.4) on the PPG mesh side and one (1.1%, CI 0.2-7.8) on the PLP side. These differences were not statistically significant (p=0.125) CONCLUSIONS: Although hernioplasty with self-adhesive mesh reduced early postoperative pain, this reduction was clinically irrelevant and it had no influence on chronic pain. There was a trend towards a higher recurrence rate when self-adhesive meshes were used, and although in this study differences were not statistically significant they should be confirmed in later studies using larger samples. Surgical procedures that do not need fixing sutures are promising, but further studies are needed before they become the gold standard of inguinal hernia repair.
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