Intérêt de la rééducation érectile précoce Par Sildénafil après radiothérapie et Proctectomie Pour Cancer du Rectum : Essai contrôlé randomisé
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 27
- 主要终点
- the patient's response
研究概览
简要总结
This study aims to evaluate the efficacy of erectile rehabilitation with Sildenafil, in men treated with neoadjuvant proctectomy and radiotherapy for rectal cancer, in preventing long-term erectile dysfunction at 12 months post-operatively.
详细描述
Colorectal cancer is the third most common cancer in men in France, after lung and prostate cancer. Proctectomy (possibly preceded by radiotherapy) is the most effective treatment for this cancer, but erectile dysfunction (ED) is a frequent complication, even when the nerves are preserved during dissection, and has a major impact on the quality of life of operated men.
The cause of erectile dysfunction after rectal cancer surgery is usually neurological, due to intraoperative trauma to the autonomic nerves, while erectile dysfunction after radiotherapy is mainly vascular in origin, with damage to erectile tissue.
Several risk factors for sexual dysfunction after rectal cancer surgery have been reported (age, neoadjuvant radiotherapy, type of resection, operative difficulties and complications, body image affected by protective stoma). On the other hand, surgical expertise may be a protective factor.
In the physiological condition, the nitric oxide released by the pelvic nerves causes an increase in cyclic guanosine monophosphate, which in turn causes smooth muscle cells relaxation and an influx of blood into the cavernous body, triggering and maintaining the erection.
Similar to prostatectomy, nerve damage can occur during proctectomy through stretching, heat, ischemia or inflammation; this nerve damage results in reduced nitric oxide production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Men aged 18 to 70
- •Patients undergoing surgery for cancer of the lower or middle rectum by total removal of the mesorectum with colorectal or coloanal anastomosis after neoadjuvant radiotherapy, with normal preoperative erectile function (defined by a combined IIEF erectile function domain score of at least 22).
- •Nerve-conserving surgery
- •Sexually active patient without treatment for erectile function prior to surgery
- •Presence of a regular sexual partner (male or female)
- •Adult having read and understood the information letter and signed the consent form
- •Membership of a social security scheme
排除标准
- •T4 tumor or tumor requiring extended surgery
- •Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than
- •History of prostate cancer
- •Sleep disorders, patients taking sedatives/hypnotics
- •Contraindication to SILDENAFIL EG 50 mg, film-coated tablet
- •Contraindication to placebo
- •Patients already treated with PDE5 inhibitors
- •Patients suffering from SARS COV 2*
- •Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship.
- •Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or to prevent the subject from giving informed consent.
- •Person participating in another drug trial.
研究组 & 干预措施
Arm I (Sildénafil)
Sildénafil during 10 months (50mg daily), start 30 days after surgery
干预措施: Sildenafil (Drug)
Arm II (Placebo)
Patients receive placebo during 10 month (1 platelet per day)
干预措施: Placebo (Other)
结局指标
主要结局
the patient's response
时间窗: 12 months postoperatively
A patient is defined as a responder by a score of at least 22 for the erectile function domain of the International Index of Erectile Function (IIEF), comprising the six IIEF questions relating to erection (Q1-Q5 and Q15).
次要结局
- IIEF erectile function domain score(Day 0, Month 1, Month 3, Month 6, Month 9, Month12)
- International Index of Erectile Function (IIEF) global score(Day 0, Month 1, Month 3, Month 6, Month 9, Month 12)
- Quality of life score(Day 0, Month 1, Month 3, Month 6, Month 9, Month 12)
- LARS score(Day 0, Month 1, Month 3, Month 6, Month 9, Month 12)
- Fecal Continence Score(Day 0, Month 1, Month 3, Month 6, Month 9, Month 12)
- Spontaneous erection evaluation(Month 1, Month 3, Month 6, Month 9, Month 12)
- Benefits of psychological follow-up(after 10 months of treatment)
- Compliance with treatment(after 10 months of treatment)
- Adverse and suspected adverse events(Month 1, Month 3, Month 6, Month 9, Month 12)
研究者
David MALLET
Scientific
Centre Hospitalier Universitaire Rouen