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临床试验/NCT07550985
NCT07550985招募中不适用

A Randomized Controlled Trial Evaluating the Effect of Routine Probe Compression After Transrectal Prostate Biopsy on Bleeding and Infectious Complications

Veterans Health Service Medical Center, Seoul, Korea1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2026年3月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
324
试验地点
1
主要终点
Incidence of clinically significant bleeding after transrectal prostate biopsy

研究概览

简要总结

Hematuria (up to 50%) and rectal bleeding (up to 30%) are common complications following transrectal ultrasound-guided prostate biopsy. Although most cases are mild, some require additional intervention. Short-duration compression has been shown to achieve hemostasis in cases of post-biopsy bleeding, suggesting that routine probe compression may reduce bleeding complications. Post-biopsy bleeding may also be associated with an increased risk of subsequent infection.

This randomized controlled trial aims to evaluate the effect of routine probe compression and compression duration after transrectal prostate biopsy on bleeding and infectious complications.

详细描述

Hematuria (approximately 50%) and rectal bleeding (approximately 30%) are common complications following transrectal ultrasound-guided prostate biopsy. Although most cases are self-limited, a subset of patients require additional intervention. In cases of significant bleeding immediately after biopsy, ultrasound-guided probe compression has been used for hemostasis, with reported compression times ranging from 1 to 8 minutes (mean 2.9 minutes), suggesting that even short-duration compression may be effective.

Digital rectal compression for 5 minutes after biopsy has been shown to reduce intraprostatic hemorrhage (hematoma), thereby improving the accuracy of subsequent magnetic resonance imaging interpretation. However, no randomized controlled trials have evaluated clinically significant bleeding outcomes, such as hematuria or rectal bleeding, as primary endpoints.

While a stepwise approach to managing moderate-to-severe rectal bleeding (initial direct compression followed by endoscopic hemostasis or embolization if needed) is generally accepted, there is no consensus regarding the optimal duration of initial compression.

Infectious complications following transrectal prostate biopsy occur in approximately 0.1-7.0% of patients, with sepsis reported in 0.3-3.1%. Post-biopsy hematuria has been suggested as a potential clinical indicator of subsequent urinary tract infection. Therefore, reducing bleeding complications may also contribute to the prevention of infectious complications.

There is a clear need for randomized evidence evaluating the effect of routine probe compression and compression duration on both bleeding and infectious outcomes. This study aims to address this gap in the current evidence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients aged ≥18 years
  • Scheduled to undergo transrectal ultrasound-guided prostate biopsy
  • Biopsy-naïve patients (first-time prostate biopsy)
  • Able to provide written informed consent

排除标准

  • Uncorrectable coagulopathy or bleeding disorder
  • Active urinary tract infection at the time of biopsy
  • Acute anorectal conditions (e.g., hemorrhoidal bleeding, anal fissure, proctitis)
  • Inability to discontinue or appropriately manage anticoagulant or antiplatelet therapy
  • History of severe drug allergy or hypersensitivity to medications used in the study
  • Individuals unable to provide informed consent (e.g., cognitive impairment, medically incapacitated) or other vulnerable populations
  • Participation in another interventional study related to prostate disease that may interfere with the outcomes of this study
  • Severe comorbid conditions limiting study participation
  • Inability to comply with follow-up procedures

研究组 & 干预措施

Probe compression (0 minutes)

No Intervention

No probe compression is applied after completion of transrectal ultrasound-guided prostate biopsy.

Probe compression (1 minute)

Active Comparator

The transrectal ultrasound probe is used to apply continuous manual pressure to the prostate via the rectal wall for 1 minute immediately after biopsy.

干预措施: Probe compression (Behavioral)

Probe compression (3 minutes)

Active Comparator

The transrectal ultrasound probe is used to apply continuous manual pressure to the prostate via the rectal wall for 3 minutes immediately after biopsy.

干预措施: Probe compression (Behavioral)

结局指标

主要结局

Incidence of clinically significant bleeding after transrectal prostate biopsy

时间窗: Within 7 days after biopsy

Proportion of patients reporting hematuria or rectal bleeding within 7 days after biopsy, assessed by structured telephone interview. Clinically significant bleeding is defined as bleeding associated with patient-reported symptoms, prolonged duration, or requiring medical attention.

次要结局

  • Incidence of infectious complications(Within 14 days after biopsy)

研究者

发起方
Veterans Health Service Medical Center, Seoul, Korea
申办方类型
Other
责任方
Sponsor

研究点 (1)

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