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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