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

Hadassah Medical Center

Status: Enrolling

Conditions: Low Anterior Resection Syndrome

Treatments: Other: Paula Method of muscle exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05682157

RCT-PAULA-LARS-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Paula Method

Experimental group

Description:

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

Treatment:

Other: Paula Method of muscle exercises

Standard Care

No Intervention group

Description:

standard care