COMPLICATION AND SAFETY OF TRANSPERINEAL PROSTATE BIOPSY USING NOVEL AFFORDABLE VY PROBE (TPPB-VY) IN CLINICAL PRACTICE : A PILOT STUDY

Ali Ridho Al Haddar, S. Pramod, Ferry Safriadi
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Abstract

Objective: This study was aimed to know the complication and safety of TPPB-VY in clinical practice. Material & Methods: TPPB were performed in 34 patients between January 2019 and Juni 2021. Ethical approval of this study was sought from the hospital authorities (IRB number: LB.02.01/X.6.5/ 55/2020). Patients underwent systematic 10-12 core TPPB depend on the prostate volume with intravenous light sedation. The patient was included to the study if PSA ≥ 4 ng/ml and/or Digital Rectal Examination (DRE) results suggestive of prostate cancer. Procedures were performed without any antibiotic prophylaxis or an enema before the procedure and post procedure the patients just get an oral fluoroquinolones and low potent analgetics (if needed). The complication include pain level post procedure (using VAS), perineal hematoma, fever and retention post biopsy were recorded. Results: In all, 34 patients were included in the study. The result showed that perineal pain perceived by patients post procedure were 76.47% (26 out of 34 patients) but the VAS score just mild around 0-2. There were 23.53% (8 out of 34 patients) hematuria, 5.88% (2 out of 34 patients) acute urinary retention and 2.9 % (1 out of 34 patients) perineal hematoma. No fever or clinical infection was observed and 82.35% (28 out of 34 patients) patients presented with minor complications (ClavienDindo I). Only one of the patients were hospitalized due to the post-biopsy complication that need intervention. Conclusion: This is the first study TPPB using Novel Affordable VY probe. The results show clinically insignificant complication without infection. TPPB using Novel Affordable VY probe is feasible and safe.
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临床实践中使用新型可负担的vy探针(tppb-vy)进行经会阴前列腺活检的并发症和安全性:一项初步研究
目的:了解TPPB-VY在临床中的并发症及安全性。材料与方法:2019年1月至2021年6月对34例患者进行TPPB。本研究已获得医院主管部门的伦理批准(IRB编号:LB.02.01/X.6.5/ 55/2020)。患者接受系统的10-12核TPPB取决于前列腺体积静脉轻镇静。如果PSA≥4 ng/ml和/或直肠指检(DRE)结果提示前列腺癌,则纳入研究。在手术前和手术后,患者只口服氟喹诺酮类药物和低效镇痛药(如果需要),没有任何抗生素预防或灌肠。术后并发症包括术后疼痛程度(VAS)、会阴血肿、发热、穿刺后潴留等。结果:共纳入34例患者。结果显示,术后患者感觉会阴疼痛的比例为76.47%(26 / 34),但VAS评分仅为轻度,在0-2左右。血尿发生率为23.53%(8例),急性尿潴留发生率为5.88%(2例),会阴血肿发生率为2.9%(1例)。34例患者中28例(82.35%)出现轻微并发症(ClavienDindo I),仅有1例患者因活检后并发症需要干预而住院。结论:这是首次使用新型可负担的VY探针研究TPPB。结果显示临床并发症轻微,无感染。使用新型经济实惠的VY探针进行TPPB是可行和安全的。
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