跳至主要内容
临床试验/NCT05682157
NCT05682157已完成不适用

Use of the Paula Method of Muscle Exercises Among Patients With Low Anterior Resection Syndrome After Sphincter-sparing Rectal Resection Using an Integrative Approach

Hadassah Medical Organization4 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年3月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
4
主要终点
Change in LARS score

研究概览

简要总结

Sphincter sparing rectal resection surgery, either total mesorectal excision (TME) with a temporary loop ileostomy or partial mesorectal excision (PME), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of Low anterior resection syndrome (LARS). This syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. There is no gold standard therapy designed to treat the root cause of the problems associated with LARS. Paula Method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. The purpose of this study is to evaluate the usefulness of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • patients 6-18 months post restorative surgery (either resection with a primary functional anastomosis or after the closure of a temporary ileostomy following curative surgery for rectal cancer) and, if applicable, at least one month post last adjuvant chemotherapy treatment
  • LARS score of 21 or greater
  • age 18 or older
  • able to read and write in Hebrew or English
  • able and willing to comply with the study requirements.

排除标准

  • Chronic anal incontinence prior to surgery
  • inability to perform exercises due to cognitive or physical limitations
  • actively engaged in pelvic floor muscle exercises
  • pregnancy.

研究组 & 干预措施

Standard Care

No Intervention

standard care

Paula Method

Experimental

12 weeks of the Paula Method of muscle exercises with standard care

干预措施: Paula Method of muscle exercises (Other)

结局指标

主要结局

Change in LARS score

时间窗: 12 weeks

Comparison of the change in LARS score from baseline to the completion of 12 weeks of the intervention (within and between groups).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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