Use of the Paula Method of Muscle Exercises Among Patients With Low Anterior Resection Syndrome After Sphincter-sparing Rectal Resection Using an Integrative Approach
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Change in LARS score
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in LARS score
Time Frame: 12 weeks
Comparison of the change in LARS score from baseline to the completion of 12 weeks of the intervention (within and between groups).
Secondary Outcomes
No secondary outcomes reported