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临床试验/NCT02538913
NCT02538913终止不适用

Exercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.

Norwegian University of Science and Technology2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
2
主要终点
Anal incontinence

研究概览

简要总结

Cancer treatments often cause acute toxicity during treatment, and late toxicity after treatments have ended. Bowel dysfunctions, incontinence (anal and urinary) and dysfunction are late side effects associated with cancer treatment in general, and patients treated for pelvic malignancies are at a higher risk. In Norway, the incidence of rectal cancer was 1329 in 2010. Advances in the treatment during the past few decades have led to fewer local recurrences and increased long-term survival, and today the relative survival is 66% for women and 64% for men. More patients are having sphincter-preserving surgery with low colorectal or ultralow coloanal anastomoses, and low anterior resection (LAR) is done in 70% of the patients with curative surgery. Unfortunately, many patients experience altered bowel function after LAR. Frequent bowel movements, urgency, evacuatory difficulties and fecal incontinence are common and distressing complications. These functional disturbances are seen in up to 50-60% of the patients, and most frequent when surgery is combined with neoadjuvant therapy. Urinary incontinence and decreased sexual function is also common in both men and women following rectal cancer treatment.

In many surgical settings, patients with higher preoperative physical fitness rehabilitate more quickly and have fewer operative complications compared with patients who are less physically fit. Additionally, specific strength training of the pelvic floor muscles builds up muscle volume, elevates the location of the pelvic floor muscles and pelvic organs, and closes the levator hiatus thus providing improved structural support for the pelvic floor as well as more optimal automatic function. The aim of the present trial is to investigate whether exercise training including pelvic floor muscle training during preoperative radiotherapy can reduce symptoms of bowel, urinary and sexual dysfunction and affect the physiology of the anal sphincter muscle after LAR. In addition quality of life, cardiopulmonary parameters and postoperative complications will be studied.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cancer recti
  • Planned curative LAR with preoperative radiotherapy
  • Cancer stadium I-III
  • Able to speak and understand Norwegian

排除标准

  • Previous radiotherapy
  • Previous pelvic surgery
  • Diseases affecting the anal sphincter

结局指标

主要结局

Anal incontinence

时间窗: 3 months post surgery

St. Marks score

次要结局

  • Physiology of the anal sphincter(3 and 12 months post surgery)
  • Sexual dysfunction(3 and 12 months post surgery)
  • Quality of life(3 and 12 months post surgery)
  • In-hospital time(Up to 12 months post surgery)
  • Anal incontinence(12 months post surgery)
  • Urinary incontinence(3 and 12 months post surgery)
  • Postoperative complications(Up to five years post surgery)
  • Physical activity level(On an average 1 week pre surgery and three months post surgery)
  • Bowel dysfunction(3 and 12 months post surgery)
  • Maximal oxygen uptake (VO2max)(On an average 1 week pre surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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