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Paula Method of Exercises in Patients With LARS Syndrome

H

Hadassah Medical Center

Status

Completed

Conditions

Low Anterior Resection Syndrome

Treatments

Other: Paula Method

Study type

Interventional

Funder types

Other

Identifiers

NCT05016583
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 feasibility of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Paula Method
Experimental group
Treatment:
Other: Paula Method

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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