Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Anterior Resection Syndrome

Intervention / Treatment
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* Other: Paula Method of muscle exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Chronic anal incontinence prior to surgery inability to perform exercises due to cognitive or physical limitations actively engaged in pelvic floor muscle exercises pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paula Method<br>12 weeks of the Paula Method of muscle exercises with standard care | Other: Paula Method of muscle exercises<br>* 12 weekly sessions of Paula Method of excercise<br>|
| No Intervention: Standard Care<br>standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LARS score | Comparison of the change in LARS score from baseline to the completion of 12 weeks of the intervention (within and between groups). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paula Method, Sphincter sparing rectal resection, Anal incontinence, Rectal Cancer