Paula Method of Exercises in Patients With LARS Syndrome

Not Applicable

Completed

• Conditions: Low Anterior Resection Syndrome
• Interventions: Other: Paula Method

• Registration Number: NCT05016583
• Lead Sponsor: Hadassah Medical Organization

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-23
• Status Verified: 2021-10
• Study Start: 2021-10-28
• Primary Completion: 2022-07-04
• Study Completion: 2022-07-04
• Last Update Submitted: 2022-10-09
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paula Method	Paula Method	-

Primary Outcome Measures

Name	Time	Method
Improvement in LARS (Low Anterior Resection Syndrome) Score	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.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel