A Non-randomised Controlled Trial of Early Intervention to Preserve Erectile Function After Laparoscopic Resection for Rectal Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in sexual function based on the (IIEF)-5 score and NPT
研究概览
简要总结
Although the high prevalence of erectile dysfunction (ED) was detected among male patients after the treatment for colorectal cancer, published reports depicting the erectile dysfunction experience of patients with colorectal cancer ot underpin service development are insufficient. Furthermore,unlike patients with prostate cancer, men with colorectal cancer are not routinely offered information and treatment for erectile dysfunction.However, investigations on patients after surgery for prostate cancer could provide some potentially useful insights. The ability of sildenafil and vacuum erection device (VED) to aid in the return of erections after nerve-sparing radical prostatectomy has been established, which may benefit rectal cancer patients after surgery with ED.
Laparoscopic surgery, although technically demanding and associated with a long learning curve, has the advantage of clear visualization for the smallest structures,including the autonomic nerves. Laparoscopic resection for rectal cancer could thus facilitate preservation of the pelvic autonomic nerves.
This study aimed to identify whether early intervention is effective at reducing the rate of ED at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 < Age < 70
- •Sexually active men without the consistent use of erectile aids pre-operatively
- •Rectal cancer confirmed by histology
- •Undergoing a bilateral nerve sparing laparoscopic rectal resection
- •IIEF-5 domain score > =20 before surgery
- •Presence of a female sexual partner
- •Willingness to participate in clinical research as evidenced by their signature on the informed consent form
排除标准
- •Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months
- •Has taken or has been prescribed nitrate medication in any form in the last 6 months
- •Contraindication to sildenafil (e.g. nitrates, hypersensitivity)
- •Contraindication to vacuum erection device (e.g. coagulation abnormality, stick cell disease)
- •Men with a history of known penile deformity or Peyronie's disease
- •Pre or postoperative androgen therapy
结局指标
主要结局
Changes in sexual function based on the (IIEF)-5 score and NPT
时间窗: 12 months
Summarized according to assigned treatment group. Erectile Dysfunction is defined by The International Index of Erectile Dysfunction(IIEF)-5 score and Nocturnal penile tumescence(NPT).
次要结局
- Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT(12 months)
研究者
Haijun Deng, MD, PhD
Associate professor
Nanfang Hospital, Southern Medical University