Exercise program for patients with Low Anterior Resection Syndrome
Use of the Paula Method of Muscle Exercises Among Patients With Low Anterior Resection Syndrome After Sphincter-sparing Rectal Resection Using an Integrative Approach
This study is testing a special exercise program to see if it can help people with Low Anterior Resection Syndrome feel better by reducing symptoms like frequent bathroom trips and urgency after their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hadassah Medical Organization Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Jerusalem and 1 other locations) |
| Trial ID | NCT05682157 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the Paula Method of exercises for patients who have developed Low Anterior Resection Syndrome (LARS) following sphincter sparing rectal resection surgery. The study aims to determine if these exercises can alleviate symptoms such as fecal frequency, urgency, and incontinence. Participants will be assessed based on their LARS scores and must be within 6-18 months post-surgery. The trial will involve patients who are able to read and write in Hebrew or English and are willing to comply with the study requirements.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are 6-18 months post restorative surgery for rectal cancer and have a LARS score of 21 or greater.
Not a fit: Patients with chronic anal incontinence prior to surgery or those unable to perform exercises due to cognitive or physical limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from LARS by reducing symptoms and enhancing bowel control.
How similar studies have performed: While the Paula Method is a novel approach, similar exercise-based interventions have shown promise in improving pelvic floor function in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jerusalem and 1 other locations
- Hadassah Medical Organization — Jerusalem, Israel (Recruiting)
- Rabin Medical Center — Petach Tikva, Israel (Not_yet_recruiting)
Study contacts
- Principal investigator: Noam Shussman, MD — Hadassah Medical Organization
- Study coordinator: Noam Shussman, MD
- Email: noams@hadassah.org.il
- Phone: +972 2 6779758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.