跳至主要内容
临床试验/NCT05016583
NCT05016583已完成不适用

Paula Method Muscle Exercises in Patients With Low Anterior Resection Syndrome After Sphincter Sparing Rectal Resection: A Feasibility Study

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Improvement in LARS (Low Anterior Resection Syndrome) 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 feasibility 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
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Over age 18
  • LARS syndrome (LARS score of 21 or higher) up to 24 months post sphincter sparing rectal resection
  • Able to read, understand and communicate in Hebrew

排除标准

  • Pregnancy
  • Actively undergoing Chemotherapy or Radiation
  • Other causes of anal incontinence or bowel dysfunction (ex: Irritable Bowel Syndrome)
  • Concurrent performance of other exercise methods
  • Unable or unwilling to perform the Paula exercises

结局指标

主要结局

Improvement in LARS (Low Anterior Resection Syndrome) Score

时间窗: 12 weeks

Decrease of in the LARS Score from baseline measurement to the end of the study measurement. The scale is based on a score of 0-42 . A score of 0-20 indicates the absence of LARS, 21-29- Minor LARS, and 30-42- Major LARS.

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 (1)

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