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Search / Trial NCT05682157

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

Paula Method Sphincter Sparing Rectal Resection Anal Incontinence Rectal Cancer

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.

Locations

Petach Tikva, , Israel

Jerusalem, , Israel

Petach Tikva, , Israel

Patients applied

0 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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