Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer
研究概览
简要总结
Sexual dysfunction is a common side effect of medical and surgical treatments for rectal cancer. It can manifest as ejaculation disorders or erectile dysfunction. Due to the modesty of both patients and doctors, these disorders are poorly understood and probably underestimated at present. Aim : Objectively assess the presence of erectile dysfunction induced by medical and surgical treatment of rectal cancer three months after surgery. These objective data will be obtained using the RIGISCAN® PLUS system coupled with polysomnographic recording.
详细描述
Sexual dysfunction is a common side effect of medical and surgical treatments for rectal cancer. It can manifest as ejaculation disorders or erectile dysfunction. Due to the modesty of both patients and doctors, these disorders are poorly understood and probably underestimated at present. After surgical treatment alone, sexual dysfunction can be observed in 40 to 90% of patients, depending on the studies and the technique used. It is the result of direct vascular and nerve damage caused during surgery. It occurs immediately after surgery. It can sometimes recover over time, up to 18 months after the operation. Pelvic radiotherapy also has side effects on sexual function. The damage is caused by alterations in microvascularization or direct nerve damage.
It develops more gradually, over a period of several weeks or months. After treatment combining radiotherapy and surgery, the risk of sexual dysfunction is significant and can affect up to 90% of patients.
In an attempt to improve these results, surgical techniques have gradually evolved towards complete resection of the mesorectum with nerve preservation. Studies published on this subject show an improvement in functional outcomes, without any deterioration in oncological outcomes. This has now become the standard surgical technique.
In the specific case of the management of neoplastic disease, it is common to observe a reactive anxiety-depression syndrome in patients. This mood disorder affects libido and sexuality. A lack of sexual activity in the postoperative period is therefore not necessarily related to iatrogenic vascular-nerve damage. In order to improve patients' quality of life, it is useful to know how to objectively diagnose post-operative erectile dysfunction. This diagnosis should make it possible to distinguish between disorders related to vascular-nervous damage and those that are part of a post-operative anxiety-depression syndrome.
An accurate diagnosis of sexual dysfunction can lead to specific treatment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 patient.
- •Age greater than 18 years.
- •Neoplastic rectal stage ≤ T
- •Patient sexually active before diagnosis.
- •Laparoscopic surgery.
- •Medico-surgical institute Bergonié.
- •Patient information and consent for participation in the study.
排除标准
- •Patients already treated for erectile dysfunction.
- •Absence of sexual activity before diagnosis.
- •Presence of secondary lesions at diagnosis (M +).
- •Classified T4 tumor preoperatively.
- •Surgery by laparotomy.
- •History of pelvic cancer surgery prostate or bladder.
- •History of pelvic radiotherapy (outside of the current process).
- •History of prostate or bladder neoplasia known.
- •Other neoplastic known.
- •Patient for psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patient deprived of liberty or under guardianship.
研究组 & 干预措施
Patients with localized rectal cancer
Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)
干预措施: Evaluation of erectile dysfunction (Other)
结局指标
主要结局
Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer
时间窗: 3 months after surgery
Erectile dysfunction is defined by the absence of normal nocturnal erections according to R/P recording (RIGISCAN® PLUS / polysomnography)
次要结局
- Quality of Nocturnal Erections(3 years after surgery)