Laparoscopic Versus Open Incisional Hernia Repair: Long-Term Follow-up Results of a Randomized Clinical Trial.

PURPOSE: Long-term extension of a previous randomized controlled clinical trial comparing open (OVHR) vs. laparoscopic (LVHR) ventral hernia repair, assessing recurrence, reoperation, mesh-related complications and self-reported quality of life with 10 years of follow-up. METHODS: Eighty-five patients were followed up to assess recurrence (main endpoint), reoperation, mesh complications and death, from the date of index until recurrence, death or study completion, whichever was first. Recurrence, reoperation rates and death were estimated by intention to treat. Mesh-related complications were only assessed in the LVHR group, excluding conversions (intraperitoneal onlay; n = 40). Quality of life, using the European Hernia Society Quality of Life score, was assessed in surviving non-reoperated patients (n = 47). RESULTS: The incidence rates with 10 person-years of follow-up were 21.01% (CI 13.24-33.36) for recurrence, 11.92% (CI: 6.60-21.53) for reoperation and 24.88% (CI 16.81-36.82) for death. Sixty-two percent of recurrences occurred within the first 2 years of follow-up. No significant differences between arms were found in any of the outcomes analyzed. Incidence rate of intraperitoneal mesh complications with 10 person-years of follow-up was 6.15% (CI 1.99-19.09). The mean EuraHS-QoL score with 13.8 years of mean follow-up for living non-reoperated patients was 6.63 (CI 4.50-8.78) over 90 possible points with no significant differences between arms. CONCLUSION: In incisional ventral hernias with wall defects up to 15 cm wide, laparoscopic repair seems to be as safe and effective as open techniques, with no long-term differences in recurrence and reoperation rates or global quality of life, although lack of statistical power does not allow definitive conclusions on equivalence between alternatives. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov (NCT04192838).

Prospective study of sexual function and analysis of risk factors after rectal cancer surgery.

AIM: The aim of this study was to assess the evolution of sexual function over time after rectal cancer surgery and to identify risk factors that may have an impact on the deterioration of postoperative function. METHOD: This was a prospective cohort study of sexual function after rectal cancer surgery using the International Index of Erectile Function (IIEF) and Female Sexual Function Index (FSFI) preoperatively and at 6 and 12 months after surgery. Predictive factors of worsening were identified by univariate and multivariate analysis. RESULTS: One hundred and one patients were included (56 men and 45 women). In men, the average IIEF showed decreased erectile function and intercourse satisfaction at 6 months (respectively 21.58 ± 7.18 to 16.60 ± 7.96, p = 0.002 and 10.87 ± 2.94, to 8.09 ± 4.45, p = 0.002) with recovery at 1 year. As a percentage, erectile dysfunction increased from the preoperative value to 6 months (64.5% vs 87.1%, p = 0.022) and was observed in 72% at 1 year. Patients with moderate to severe dysfunction increased from 22% preoperatively to 58% (p = 0.009) at 6 months and 44% at 1 year (p < 0.0001). Neoadjuvant chemoradiotherapy (OR 5.4, 95% CI 0.9-29.6; p = 0.041) and erectile worsening at 6 months (OR 20, 95% CI 1.6-238; p = 0.004) were independent factors for worse function at 6 or 12 months, respectively. No significant worsening of the FSFI was found, although there was an improvement in lubrication and orgasm. CONCLUSION: Temporary deterioration of erectile function in men is common at 6 months after surgery and chemoradiotherapy is the only predictive factor. Furthermore, patients who remain dysfunctional show an increase in the severity of symptoms in relation to the preoperative period.