Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial
Launched by HADASSAH MEDICAL ORGANIZATION · Dec 27, 2022
Trial Information
Current as of May 08, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effectiveness of the Paula Method of exercises for patients experiencing Low Anterior Resection Syndrome (LARS) after surgery for rectal cancer. LARS can cause uncomfortable symptoms like frequent and urgent bowel movements, which can lead to accidents. The Paula Method is based on the idea that exercising certain muscles can help improve the function of other related muscles, potentially helping those affected by LARS.
To be eligible for the trial, participants need to be 18 years or older, have undergone restorative surgery 6 to 18 months prior, and have a LARS score of 21 or higher, indicating more severe symptoms. They should also be able to read and write in Hebrew or English and be willing to follow the study requirements. Participants will engage in the Paula Method exercises and will be monitored to see if these exercises help improve their symptoms. It's important to note that individuals with chronic anal incontinence before surgery or those currently doing similar exercises are not eligible for the study.
Gender
ALL
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.
About Hadassah Medical Organization
Hadassah Medical Organization (HMO) is a leading healthcare institution based in Jerusalem, Israel, renowned for its commitment to advancing medical research and improving patient care. As a prominent clinical trial sponsor, HMO leverages its state-of-the-art facilities and multidisciplinary expertise to conduct innovative research across various therapeutic areas. The organization is dedicated to fostering collaboration between clinical researchers, healthcare professionals, and academic institutions, ensuring the highest standards of ethical practice and scientific rigor. HMO's mission is to translate groundbreaking research into effective treatments, ultimately enhancing health outcomes for diverse populations both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Petach Tikva, , Israel
Jerusalem, , Israel
Petach Tikva, , Israel
Patients applied
Trial Officials
Noam Shussman, MD
Principal Investigator
Hadassah Medical Organization
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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