Paula Method of Exercises in Patients With LARS Syndrome

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.

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Key information

Conditions

Low Anterior Resection Syndrome Behavior Behavioral Symptoms Colonic Diseases Digestive System Diseases Elimination Disorders Encopresis Gastrointestinal Diseases Intestinal Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paula Method

Other

12 weeks of Paula Method of Exercises

Primary outcomes

Improvement in LARS (Low Anterior Resection Syndrome) Score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Aug 23, 2021
Registry last updated: Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed