Impact of Preoperative Ejaculation or Abstinence on Seminal Vesicle Size and Intraoperative Dissection Parameters During Radical Prostatectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Seminal vesicle volume measured by preoperative transrectal ultrasound (TRUS)
研究概览
简要总结
The goal of this clinical trial is to learn if recent ejaculation or abstinence before surgery affects seminal vesicle size and dissection-related surgical factors in adult men with prostate cancer undergoing radical prostatectomy. The main questions it aims to answer are:
Does ejaculation within 36 hours before surgery reduce seminal vesicle size compared to abstinence of 72 hours or more?
Does seminal vesicle size affect the ease or difficulty of surgical dissection during radical prostatectomy?
Researchers will compare an ejaculation group to an abstinence group to see if seminal vesicle volume and intraoperative surgical parameters differ between them.
Participants will:
Follow specific instructions to either ejaculate or abstain before surgery
Undergo a transrectal ultrasound (TRUS) to measure seminal vesicle size after anesthesia but before surgery
Have their surgical dissection time and difficulty rated by the operating surgeon
详细描述
Radical prostatectomy (RP) remains a cornerstone treatment for localized prostate cancer. During RP, the anatomical dissection of seminal vesicles (SVs) can be challenging, and SV volume may influence intraoperative visibility, dissection ease, and the risk of complications.
Recent imaging studies suggest that ejaculatory activity significantly affects SV size. In particular, abstinence has been associated with larger SV volumes on MRI and TRUS, while ejaculation may lead to temporary SV shrinkage. These physiological changes, though well-documented radiologically, have not been systematically studied in a surgical setting.
This trial aims to explore whether ejaculatory behavior in the days before RP alters the surgical anatomy and impacts dissection-related metrics. Forty adult male patients with biopsy-confirmed prostate cancer, scheduled for RP, will be randomized in a 1:1 ratio into two groups:
Ejaculation group: At least one ejaculation within 36 hours preoperatively.
Abstinence group: No ejaculation for ≥72 hours before surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The operating surgeon was masked to the participant's group assignment. Group allocation was concealed until after surgery. Neither the participant nor the research investigator performing TRUS was masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 18 years or older
- •Histologically confirmed prostate cancer
- •Scheduled for radical prostatectomy
- •Able and willing to comply with assigned ejaculation or abstinence protocol
- •Willing to complete preoperative questionnaire
- •Willing to undergo transrectal ultrasound (TRUS) 12-14 hours before surgery
- •Able to understand and sign informed consent
排除标准
- •Prior bilateral seminal vesicle resection or congenital absence of seminal vesicles
- •Anatomical abnormalities preventing SV identification
- •Hormone therapy within 6 months before surgery
- •Inability to recall ejaculation history in the past 3 days
- •Inability to follow behavioral instructions or TRUS protocol
- •Severe anorectal disease or history of anorectal surgery preventing TRUS
- •Cognitive or psychiatric conditions impairing informed consent
- •Incomplete data or poor-quality imaging
- •Prior prostate cancer treatment
- •Belonging to a vulnerable population (e.g., minors, prisoners, pregnant individuals, cognitively impaired, etc.)
研究组 & 干预措施
Recent Ejaculation Group
Participants in this group will be instructed to have at least one ejaculation within 36 hours before surgery. Under anesthesia, they will undergo transrectal ultrasound (TRUS) to measure seminal vesicle volume prior to radical prostatectomy. Intraoperative dissection time, difficulty, and visual clarity will also be recorded.
干预措施: Recent Ejaculation (Behavioral)
Abstinence Group
Participants in this group will be instructed to abstain from ejaculation for at least 72 hours before surgery. Under anesthesia, they will undergo transrectal ultrasound (TRUS) to measure seminal vesicle volume prior to radical prostatectomy. Intraoperative dissection time, difficulty, and visual clarity will also be recorded.
干预措施: Preoperative Abstinence (Behavioral)
结局指标
主要结局
Seminal vesicle volume measured by preoperative transrectal ultrasound (TRUS)
时间窗: 12-14 hours before surgery (afternoon prior to operation)
Seminal vesicle volume is measured by the research investigator using transrectal ultrasound (TRUS) in the outpatient ultrasound room approximately 12-14 hours before surgery. Both vesicles are measured in three dimensions (length × width × height), and the average volume is calculated using the ellipsoid formula (L × W × H × 0.52). The values will be compared between groups with recent ejaculation versus abstinence.
次要结局
- Dissection time of seminal vesicles during radical prostatectomy(During surgery (intraoperative))
- Surgical difficulty score of seminal vesicle dissection(Immediately after SV dissection during surgery)
- Intraoperative visual clarity score of seminal vesicles(During SV dissection, intraoperatively)
- Seminal vesicle volume reported in postoperative pathology(Within 7 days after surgery (postoperative pathology report))