Reduction of Perioperative Antibiotic Prophylaxis in Open Radical Cystectomy with Ileal Conduit Is Feasible: Results of a Prospective Clinical Trial

<b><i>Introduction:</i></b> The aim of this study is to perform a prospective clinical trial in antibiotic prophylaxis, infectious complication, and colonization of ileal conduit (IC) following radical cystectomy (RC) since urinary tract infections (UTIs) and surgical site infections (SSIs) contribute significantly to the morbidity associated with RC and IC. Moreover, an optimal regimen of antibiotic prophylaxis has not been established, yet. <b><i>Material and Methods:</i></b> After a positive vote of ethical review committee and the registration at the German Clinical Trials Register (DKRS 00020406), we started a prospective clinical unicentric not interventional study. The urine samples were collected by sterile catheterization of the IC. All patients received an antibiotic prophylaxis with 3 × 500 mg metronidazole and 3 × 1.5 g cefuroxime intravenously for 3 days starting on the day before RC. Ureteral stents got removed on days 9 and 10 after surgery without prior antibiotic administration. The student <i>t</i> test and the χ² test or the Fisher exact test were used. For risk factor assessment, the univariate Cox regression method was applied. <b><i>Results:</i></b> Nineteen male (63.3%) and 11 female patients (36.7%) with a median age of 70.5 years were included. Three patients developed complicated UTI (10%) on day 12 after RC with <i>E. faecium</i> and needed antibiotic treatment with meropenem (Clavien-Dindo II). Two patients (6.7%) developed SSI with <i>E. faecium</i> and needed surgery (Clavien-Dindo IIIb). Palliative RC (<i>p</i> &#x3c; 0.0001), prior radiation therapy (<i>p</i> &#x3c; 0.0001), and timeframe &#x3e;3 months from diagnosis to RC (<i>p</i> = 0.036) are significantly associated with the development of complicated UTI. Interestingly, the IC got colonized with Staph. haemolyticus at day 12 after RC (<i>n</i> = 12; 40.0%). We must assume that our data have some limitations like a unicentric study population. <b><i>Conclusion:</i></b> Further evaluation of reduction to single-shot antibiotic prophylaxis in nonpalliative RC with IC could be feasible.

Sensorimotor performance in acute-subacute non-specific neck pain: a non-randomized prospective clinical trial with intervention

Background The assessment of cervical spine kinematic axial rotation performance is of great importance in the context of the study of neck sensorimotor control. However, studies addressing the influence of the level of provocation of spinal pain and the potential benefit of passive manual therapy mobilizations in patients with acute-subacute non-specific neck pain are lacking. Methods A non-randomized prospective clinical trial with an intervention design was conducted. We investigated: (1) the test-retest reliability of kinematic variables during a fast axial head rotation task standardized with the DidRen laser test device in 42 Healthy pain-free Control Participants (HCP) (24.3 years ±6.8); (2) the differences in kinematic variables between HCP and 38 patients with Acute-subacute Non-Specific neck Pain (ANSP) assigned to two different groups according to whether their pain was localized in the upper or lower spine (46.2 years ±16.3); and (3) the effect of passive manual therapy mobilizations on kinematic variables of the neck during fast axial head rotation. Results (1) Intra-class correlation coefficients ranged from moderate (0.57 (0.06-0.80)) to excellent (0.96 (0.91-0.98)). (2) Kinematic performance during fast axial rotations of the head was significantly altered in ANSP compared to HCP (age-adjusted) for one variable: the time between peaks of acceleration and deceleration (p<0.019). No significant difference was observed between ANSP with upper vs lower spinal pain localization. (3) After the intervention, there was a significant effect on several kinematic variables, e.g., ANSP improved peak speed (p<0.007) and performance of the DidRen laser test (p<0.001), with effect sizes ranging from small to medium. Conclusion (1) The DidRen laser test is reliable. (2) A significant reduction in time between acceleration and deceleration peaks was observed in ANSP compared to HCP, but with no significant effect of spinal pain location on kinematic variables was found. (3) We found that neck pain decreased after passive manual therapy mobilizations with improvements of several kinematic variables. Trial registration Registration Number: NCT 04407637