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Background Standard 24-h antibiotic prophylaxis (AP) is widely employed to minimize the risk of infection complications (ICs) within 30 days following a radical cystectomy (RC). However, a considerable variety of prophylaxis protocols do not prevent a high ICs rate after surgery (37–67%). Therefore, antibiotic’s type and its duration are still controversial for AP.( Objective To compare standard 24-h AP with a prolonged 120-h regimen in a multicenter randomized clinical trial. Methods Patients were randomized in a 1:1 ratio to standard 24-h AP regimen (Group A) versus the prolonged meropenem AP 120-h (Group B). The primary endpoint was an event rate defined as the frequency of ICs within 30 days. The secondary endpoint were biomarker’s analysis and antibiotic re-administration rate (ArAR). Results A total of 92 patients were enrolled. The Clavien-Dindo complications rate did not differ between the groups (p = 0.065), however the overall complication rate was higher in Group A (63.0% vs. 34.8%, p = 0.007). The infection complication rate was 2.75 times higher in the standard antibiotic prophylaxis group: 47.8% compared to 17.4% cases in Group B (p = 0.002). The new prolonged antibiotic regimen decreased the risk of ICs (OR 0.23; 95% CI 0.08–.598; p = 0.003). The event-free survival for ICs of clinical interest in group A was 7.00 days and in group B was 9.00 days (HR = 0.447; 0.191–1.050, p = 0.065). The ArAR was higher in Group A -47.8%, while in Group B it was only in 17.4% of the cases. The incidence of bacteriuria before RC was the same between groups (p = 0.666), however, after stent removal the risk of a positive culture was lower in group B (RR = 0.64; 95% CI 0.37–1.08; p = 0.05). Conclusions The administration AP over 120-h appears to be safe and feasible, demonstrating a reduction in the total number of complications and ArAR. Trial registration in Clinical Trials: NCT05392634. Trial registration in Clinical Trials: NCT05392634.
Background Standard 24-h antibiotic prophylaxis (AP) is widely employed to minimize the risk of infection complications (ICs) within 30 days following a radical cystectomy (RC). However, a considerable variety of prophylaxis protocols do not prevent a high ICs rate after surgery (37–67%). Therefore, antibiotic’s type and its duration are still controversial for AP.( Objective To compare standard 24-h AP with a prolonged 120-h regimen in a multicenter randomized clinical trial. Methods Patients were randomized in a 1:1 ratio to standard 24-h AP regimen (Group A) versus the prolonged meropenem AP 120-h (Group B). The primary endpoint was an event rate defined as the frequency of ICs within 30 days. The secondary endpoint were biomarker’s analysis and antibiotic re-administration rate (ArAR). Results A total of 92 patients were enrolled. The Clavien-Dindo complications rate did not differ between the groups (p = 0.065), however the overall complication rate was higher in Group A (63.0% vs. 34.8%, p = 0.007). The infection complication rate was 2.75 times higher in the standard antibiotic prophylaxis group: 47.8% compared to 17.4% cases in Group B (p = 0.002). The new prolonged antibiotic regimen decreased the risk of ICs (OR 0.23; 95% CI 0.08–.598; p = 0.003). The event-free survival for ICs of clinical interest in group A was 7.00 days and in group B was 9.00 days (HR = 0.447; 0.191–1.050, p = 0.065). The ArAR was higher in Group A -47.8%, while in Group B it was only in 17.4% of the cases. The incidence of bacteriuria before RC was the same between groups (p = 0.666), however, after stent removal the risk of a positive culture was lower in group B (RR = 0.64; 95% CI 0.37–1.08; p = 0.05). Conclusions The administration AP over 120-h appears to be safe and feasible, demonstrating a reduction in the total number of complications and ArAR. Trial registration in Clinical Trials: NCT05392634. Trial registration in Clinical Trials: NCT05392634.
Стандартная 24‑часовая антибиотикопрофилактика (АП) широко используется для минимизации риска осложнений с инфекцией в течение 30 дней после радикальной цистэктомии (РЦЭ). Однако значительное разнообразие протоколов, комбинаций антибактериальных препаратов и продолжительность назначения не предотвращают высокий уровень инфекционных осложнений после операции, частота которых может достигать 37–67 %.Целью настоящего исследования является оценка риска развития инфекционных осложнений в период 30 дней после РЦЭ в хирургическом стационаре, работающем по протоколу ERAS при сравнении стандартного 24‑часового режима АП в сравнении с 120‑часовым (пролонгированный режим).Материалы и методы: 92 пациента были рандомизированы в соотношении 1:1 на стандартный 24‑часовой режим антибиотиков (стандартная АП) и пролонгированный режим с применением меропенема в течении 120 часов. В данной работе были рассмотрены вторичные конечные точки — динамика биомаркеров системного воспалительного ответа и частота развития приобретенных карбапенемаз на фоне пролонгированной АП.Результаты: Исходные и периоперационные характеристики были сбалансированы между группами. Анализ системного воспаления не выявил значимых изменений уровня системного воспалительного ответа в динамике на 1‑е и 14‑е сутки после операции (р = 0,791 и р = 0,219). При этом динамика уровня СРБ была менее интенсивная в группе пролонгированной АП, особенно на 1‑е сутки после операции (р = 0,020). Чаще всего выявлялись карбопенемазы классов B и D, ассоциированные с повышенным риском инфекционных осложнений. Кроме того, в группе пролонгированной АП отмечено снижение встречаемости карбопенем‑продуцирующих штаммов (p = 0,111), где регрессионный анализ показал связь между выявлением карбопенемаз и развитием инфекционных осложнений (ОР 2,73, p = 0,024).Выводы: Данное проспективное рандомизированное исследование демонстрирует, что пролонгированная антибиотикопрофилактика эффективно снижает 30‑дневные послеоперационные осложнения после радикальной цистэктомии, при этом обеспечивая менее выраженный подъем С‑реактивного белка и не увеличивая частоту антибиотикорезистентности, что открывает новые горизонты для обновления протоколов в онкохирургии.
Background: Negative pressure wound treatment (NPWT) is a relatively new, but promising method for management of surgical site infection (SSI). The literature data on the use of NPWT for complications in oncology surgery, and after radical cystectomy (RC) in particular, is scarce. Aim: To evaluate the short-term results of NPWT dressings in the management of SSI after RC. Materials and methods: We retrospectively analyzed data from 446 patients who had RC with various uroderivation types in the Department of Oncourology of the N. N. Petrov National Medical Research Center of Oncology from January 2012 to December 2021. A total of 62 cases of SSI emerging up to day 30 after RC were identified with complete data. Thirty six (36) cases of SSI were managed according to standard procedures, and 26 patients with SSI were treated with NPWT (VivanoTec® S 042) at constant negative pressure mode. The physical condition of the patients before RC was assessed according to the American Society of Anesthesiology (ASA) classification, and the severity of the patient's condition at SSI diagnosis within APACHE II scale. The following parameters were also analyzed: body mass index, median number of days in the hospital, number of program wound sanitations (surgical debridement) or frequency of changing NPWT dressings, changes over time in C-reactive protein and leukocyte index of intoxication, and events of clinical interest (intestinal fistulas and lateralization of the median wound margins, hernias). Results: Most cases of post-RC SSIs were identified in men (57/62, 91.93%). The standard management and NPWT study groups were well balanced for age, body mass index, and ASA physical status. The median time from the first surgical debridement of the wound to its closure was significantly shorter in the standard surgical management group: 4 days (0; 8.75) versus 8.5 days (3.25; 12.0) in the NPWT group (p = 0.026). However, this did not negatively affect the length of hospitalization (28.08 ± 12.80 and 30.03 ± 16.27 days, respectively, p = 0.599). The 30-day mortality rates were not significantly different between the groups (p = 0.137). In our series with NPWT dressings, there were no cases of intestinal fistulas in the early and late postoperative periods. Conclusion: Negative pressure wound treatment is a safe and effective method of SSI management. It is not inferior to the generally accepted treatment standard with surgical wound debridement, staged sanitations or dressings. NPWT dressings allow for early primary muscular-fascial closure of the abdominal cavity and does not increase the duration of hospital stay, postoperative death rates and the risk of intestinal fistulas.
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