NCT05682157

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2023Oct 2026

First Submitted

Initial submission to the registry

December 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

December 27, 2022

Last Update Submit

March 12, 2025

Conditions

Low Anterior Resection Syndrome

Keywords

Paula MethodSphincter sparing rectal resectionAnal incontinenceRectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in LARS score

    Comparison of the change in LARS score from baseline to the completion of 12 weeks of the intervention (within and between groups).

    12 weeks

Study Arms (2)

Paula Method

EXPERIMENTAL

12 weeks of the Paula Method of muscle exercises with standard care

Other: Paula Method of muscle exercises

Standard Care

NO INTERVENTION

standard care

Interventions

Paula Method of muscle exercisesOTHER

12 weekly sessions of Paula Method of exercise

Paula Method

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Chronic anal incontinence prior to surgery
  • inability to perform exercises due to cognitive or physical limitations
  • actively engaged in pelvic floor muscle exercises
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Low Anterior Resection SyndromeEncopresisRectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental DisordersColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Noam Shussman, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noam Shussman, MD

CONTACT

+972 2 6779758noams@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 12, 2023

Study Start

March 21, 2023

Primary Completion

February 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)