Assessment of an umbilical venous catheter dwell-time of 8-14 days versus 1-7 days in very low birth weight infacts (UVC - You Will See): a pilot single-center, randomized controlled trial.

BACKGROUND: Umbilical venous catheters (UVCs) are used for central vascular access in preterm infants, but controversy exits with regard to the optimum dwell-time. PATIENTS AND METHODS: Prospective, randomized controlled trial at a level III University neonatal intensive care unit (NICU), comparing a UVC dwell-time of 1-7 days (control group) to 8-14 days (intervention group) in very low birth weight (VLBW) infants. PRIMARY OUTCOME PARAMETER: Number of infants requiring additional peripherally inserted central catheters (PICC) after removal of UVC. SECONDARY OUTCOME PARAMETERS: Total number of central lines (CL = UVC and PICCs) until time point of full enteral feeds (130-160 mL/kg/d), total number of intravenous vascular catheters, number of CL-associated complications (infection, thrombosis/emboli, organ injury, secondary CL dislocation), number of X-rays for assessment of CL positioning, and days of therapy (DOT) (teicoplanin) for CL-associated blood stream infections (CLABSI). RESULTS: Of 116 patients screened for eligibility, 63 patients were enrolled - control group: 31 infants, mean gestational age (GA) 280 weeks (standard deviation (SD) 2.6 weeks), mean birth weight (BW) 988.9 g (SD 322.0 g); intervention group: 32 infants, mean GA 285 weeks (SD 3.0 weeks), mean BW 1078.9 g (SD 324.6 g). In the control group, 28 infants required additional PICCs versus 16 in the intervention group (p < 0.001); total number of CLs: control group n = 58 versus intervention group n = 28; p < 0.001, and the total number of venous vascular devices was also significantly higher in the control group (109 versus 61; p = 0.04). No significant differences were seen with regard to CL-associated complications (p = 0.09). The number of X-rays for assessment of correct CL-position significantly lower in the intervention group (144 versus 96; p = 0.03). In the intervention group, length of hospital stay was significantly shorter (88.1 (SD: 35.3 days) versus 68.1 (SD: 32.6 days); p = 0.03) and GA significantly lower at discharge from the hospital (404: SD: 33 weeks) versus 385: SD: 25 weeks; p = 0.02. No differences existed with regard to neonatal morbidities and mortality at 36 weeks gestational age. CONCLUSIONS: A longer UVC dwell-time of up to 14 days significantly decreased the number of painful invasive vascular procedures and radiation exposure, and shortened the length of the hospital stay. The findings of our pilot study should be confirmed in a larger, multi-center RCT with the primary focus on catheter-associated complications.

Frailty assessment tools predict perioperative outcome in elderly patients with endometrial cancer better than age or BMI alone: a retrospective observational cohort study.

OBJECTIVE: Five commonly used global health assessment tools have been evaluated to identify and assess the preoperative frailty status and its relationship with perioperative in-hospital complications and transfusion rates in older women with endometrial cancer (EC). METHODS: Preoperative frailty status was examined by the G8 questionnaire, the Eastern Cooperative Oncology Group performance status, the Charlson Comorbidity Index and the American Society of Anesthesiologists Physical Status System, as well as the Lee-Schonberg prognostic index. The main outcome measures were perioperative laboratory values, intraoperative surgical parameters and immediately postoperative complications. RESULTS: 153 consecutive women ≥ 60 years with all stages of EC, who received primary elective surgery at the University Medical Center Mainz between 2008 and 2019 were classified with selected global health assessment tools according to their preoperative performance status. In contrast to conventional prognostic parameters like older age and higher BMI, increasing frailty was significantly associated with preoperative anemia and perioperative transfusions (p < 0.05). Moreover, in patients preoperatively classified as frail significantly more postoperative complications (G8 Score: frail: 20.7% vs. non-frail: 6.7%, p = 0.028; ECOG: frail: 40.9% vs. non-frail: 2.8%, p = 0.002; and CCI: frail: 25.0% vs. non-frail: 7.4%, p = 0.003) and an increased length of hospitalization were recorded. According to propensity score matching, the risk for developing postoperative complications for frail patients was approximately two-fold higher, depending on which global health assessment tool was used. CONCLUSIONS: Preoperatively assessed frailty significantly predicts post-surgical morbidity rates in contrast to conventionally used single prognostic parameters such as age or BMI. A standardized preoperative assessment of frailty in the routine work-up might be beneficial in older cancer patients before major surgery to include these patients in a prehabilitation program with nutrition counseling and physiotherapy to adequately assess the perioperative risk.

Honest, Open, Proud for adolescents with mental illness: pilot randomized controlled trial.

BACKGROUND: Due to public stigma or self-stigma and shame, many adolescents with mental illness (MI) struggle with the decision whether to disclose their MI to others. Both disclosure and nondisclosure are associated with risks and benefits. Honest, Open, Proud (HOP) is a peer-led group program that supports participants with disclosure decisions in order to reduce stigma's impact. Previously, HOP had only been evaluated among adults with MI. METHODS: This two-arm pilot randomized controlled trial included 98 adolescents with MI. Participants were randomly assigned to HOP and treatment as usual (TAU) or to TAU alone. Outcomes were assessed pre (T0/baseline), post (T1/after the HOP program), and at 3-week follow-up (T2/6 weeks after T0). Primary endpoints were stigma stress at T1 and quality of life at T2. Secondary outcomes included self-stigma, disclosure-related distress, empowerment, help-seeking intentions, recovery, and depressive symptoms. The trial is registered on ClinicalTrials (NCT02751229; http://www.clinicaltrials.gov). RESULTS: Compared to TAU, adolescents in the HOP program showed significantly reduced stigma stress at T1 (d = .92, p < .001) and increased quality of life at T2 (d = .60, p = .004). In a longitudinal mediation model, the latter effect was fully mediated by stigma stress reduction at T1. HOP further showed significant positive effects on self-stigma, disclosure-related distress, secrecy, help-seeking intentions, attitudes to disclosure, recovery, and depressive symptoms. Effects at T1 remained stable or improved further at follow-up. In a limited economic evaluation HOP was cost-efficient in relation to gains in quality of life. CONCLUSIONS: As HOP is a compact three-session program and showed positive effects on stigma and disclosure variables as well as on symptoms and quality of life, it could help to reduce stigma's negative impact among adolescents with MI.

Efficacy and safety of preoperative IOP reduction using a preservative-free fixed combination of dorzolamide/timolol eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabeculectomy in glaucoma.

INTRODUCTION: To demonstrate that preoperative treatment for 28 days with topical dorzolamide/timolol is non-inferior (Δ = 4 mm Hg) to oral acetazolamide and topical dexamethasone (standard therapy) in terms of intraocular pressure (IOP) reduction 3 and 6 months after trabeculectomy in glaucoma patients. MATERIALS AND METHODS: Sixty-two eyes undergoing trabeculectomy with mitomycin C were included in this monocentric prospective randomized controlled study. IOP change between baseline and 3 months post-op was defined as the primary efficacy variable. Secondary efficacy variables included the number of 5-fluorouracil (5-FU) injections, needlings, suture lyses, preoperative IOP change, hypertension rate and change of conjunctival redness 3 and 6 months post-op. Safety was assessed based on the documentation of adverse events. RESULTS: Preoperative treatment with topical dorzolamide/timolol was non-inferior to oral acetazolamide and topical dexamethasone in terms of IOP reduction 3 months after trabeculectomy (adjusted means -8.12 mmHg versus -8.30 mmHg; Difference: 0.18; 95% CI -1.91 to 2.26, p = 0.8662). Similar results were found 6 months after trabeculectomy (-9.13 mmHg versus -9.06 mmHg; p = 0.9401). Comparable results were also shown for both groups concerning the classification of the filtering bleb, corneal staining, and numbers of treatments with 5-FU, needlings and suture lyses. More patients reported AEs in the acetazolamide/dexamethasone group than in the dorzolamide/timolol group. DISCUSSION: Preoperative, preservative-free, fixed-dose dorzolamide/timolol seems to be equally effective as preoperative acetazolamide and dexamethasone and has a favourable safety profile.