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

NCT ID: NCT05682157

Condition: Low Anterior Resection Syndrome

Conditions: Official terms:
Low Anterior Resection Syndrome
Syndrome

Conditions: Keywords:
Paula Method
Sphincter sparing rectal resection
Anal incontinence
Rectal Cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: Paula Method of muscle exercises
Description: 12 weekly sessions of Paula Method of exercise
Arm group label: Paula Method

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hadassah Medical Organization

Address:
City: Jerusalem
Country: Israel

Status: Recruiting

Contact:
Last name: Hadas Lemberg, PhD

Phone: 00 972 2 6777572
Email: lhadas@hadassah.org.il

Facility:
Name: Rabin Medical Center

Address:
City: Petach Tikva
Country: Israel

Status: Not yet recruiting

Contact:
Last name: Ian White, MD

Start date: March 21, 2023

Completion date: October 1, 2025

Lead sponsor:
Agency: Hadassah Medical Organization
Agency class: Other

Source: Hadassah Medical Organization

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05682157

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