Methylprednisolone Pulses Plus Tacrolimus in Addition to Standard of Care vs. Standard of Care Alone in Patients With Severe COVID-19. A Randomized Controlled Trial.

Introduction: Severe lung injury is triggered by both the SARS-CoV-2 infection and the subsequent host-immune response in some COVID-19 patients. Methods: We conducted a randomized, single-center, open-label, phase II trial with the aim to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) vs. SoC alone, in hospitalized patients with severe COVID-19. The primary outcome was time to clinical stability within 56 days after randomization. Results: From April 1 to May 2, 2020, 55 patients were prospectively included for subsequent randomization; 27 were assigned to the experimental group and 28 to the control group. The experimental treatment was not associated with a difference in time to clinical stability (hazard ratio 0.73 [95% CI 0.39-1.37]) nor most secondary outcomes. Median methylprednisolone cumulative doses were significantly lower (360 mg [IQR 360-842] vs. 870 mg [IQR 364-1451]; p = 0.007), and administered for a shorter time (median of 4.00 days [3.00-17.5] vs. 18.5 days [3.00-53.2]; p = 0.011) in the experimental group than in the control group. Although not statistically significant, those receiving the experimental therapy showed a numerically lower all-cause mortality than those receiving SoC, especially at day 10 [2 (7.41%) vs. 5 (17.9%); OR 0.39 (95% CI 0.05-2.1); p = 0.282]. The total number of non-serious adverse events was 42 in each the two groups. Those receiving experimental treatment had a numerically higher rate of non-serious infectious adverse events [16 (38%) vs. 10 (24%)] and serious infectious adverse events [7 (35%) vs. 3 (23%)] than those receiving SoC. Conclusions: The combined use of methylprednisolone pulses plus tacrolimus, in addition to the SoC, did not significantly improve the time to clinical stability or other secondary outcomes compared with the SoC alone in severe COVID-19. Although not statistically significant, patients receiving the experimental therapy had numerically lower all-cause mortality than those receiving SoC, supporting recent non-randomized studies with calcineurin inhibitors. It is noteworthy that the present trial had a limited sample size and several other limitations. Therefore, further RCTs should be done to assess the efficacy and safety of tacrolimus to tackle the inflammatory stages of COVID-19. Clinical Trial Registration: Identifier [NCT04341038/EudraCT: 2020-001445-39].

Incidence and risk factors for trocar-site incisional hernia detected by clinical and ultrasound examination: a prospective observational study.

BACKGROUND: Trocar site incisional hernia (TSIH) is the most frequent complication associated with laparoscopic surgery. Few studies currently describe its incidence or risk factors. The aim of this report is to determine the real incidence of TSIH and to identify risk factors. METHODS: A cross-sectional prospective study was performed including consecutive patients who underwent a laparoscopic procedure during a 4 months period. All the patients were assessed both clinically (TSIHc) and by an ultrasonographic examination (TSIHu). The main variable studied was the incidence of TSIH. A multivariate analysis was performed to identify risk factors. RESULTS: 76 patients were included. 27.6% of patients were clinically diagnosed as having TSIH (TSIHc) but only 23.7% of those cases were radiologically confirmed (TSIHu). In the logistic regression analysis, age > 70 years (OR 3.462 CI 1.14-10.515, p = 0.028) and body mass index (BMI) ≥ 30 kg/m2 (OR 3.313 CI 1.037-10.588, p = 0.043) were identified as risk factors for TSIH. The size of the trocar also showed statistically significant differences (p < 0.001). Mean follow-up time was 34 months. CONCLUSIONS: TSIH is under-diagnosed due to the lack of related symptomatology and the inadequacy of the postoperative follow-up period. We detected discrepancies between the clinical and ultrasonographic examinations. TSIHu should be considered as the gold standard for the diagnosis of TSIH. Risk factors such as age, BMI and size of the trocar were confirmed. Patients should be followed-up for a minimum of 2 years. Trial registration The study has been retrospectively registered in Clinicaltrials.gov on June 4, 2020 under registration number: NCT04410744.

Accuracy and safety of second-generation PillCam COLON capsule for colorectal polyp detection.

PillCam COLON capsule endoscopy (CCE) (Given Imaging Ltd, Yoqneam, Israel) is one of the most recent diagnostic, endoscopic technologies designed to explore the colon. CCE is a noninvasive, patient-friendly technique that is able to explore the colon without requiring sedation and air insufflation. The first generation of CCE was released onto the market in 2006 and although it generated great enthusiasm, it showed suboptimal accuracy. Recently, a second-generation system (PillCam COLON 2) (CCE-2) has been developed to increase sensitivity for colorectal polyp detection. In this review, accuracy and safety data for CCE-2 are analyzed.