跳至主要内容
临床试验/NCT04262609
NCT04262609进行中(未招募)不适用

Faecal Incontinence in Prostate Cancer Survivors Treated With Moderately Hypofractionated Radiotherapy

Consorci Sanitari de Terrassa1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
faecal incontinence after prostate radiation therapy

研究概览

简要总结

The objective of the study is to determine the incidence of faecal incontinence in prostate cancer survivors treated with moderately hypofractionated radiation therapy and correlate the dose received by the anal sphincter with the degree of faecal incontinence.

详细描述

The investigators know that high doses of irradiation in the anal sphincter are associated with more chronic fecal leaks in survivors irradiated by normofractionated radiotherapy prostate cancer.

The safe dose of irradiation of the anal sphincter with radiotherapy modern techniques (volumetric modulated arc therapy with moderately hypofracctionation) is unknown.

Urgency and faecal incontinence greatly affects the quality of life of these patients.

Therefore, it is interesting to implement strategies to protect the anatomical structures involved in fecal continence.

The objective of the study is to determine the incidence of faecal incontinence in prostate cancer survivors treated with modern moderately hypofractionated radiation therapy and correlate the dose received by the anal sphincter with the degree of faecal incontinence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Prostate cancer survivors treated in our department by hypofractionated radiotherapy

排除标准

  • Relapse of prostate cancer
  • Other active cancer
  • Mental disorder

结局指标

主要结局

faecal incontinence after prostate radiation therapy

时间窗: change 5 years after completion of radiotherapy

grade of faecal incontinence in prostate cancer survivors

次要结局

  • Quality of life after prostate radiation therapy(5 years after completion of radiotherapy)

研究者

发起方
Consorci Sanitari de Terrassa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joan Lozano Galan

Principal investigator

Consorci Sanitari de Terrassa

研究点 (1)

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