Paula Method of Exercises in Patients With LARS Syndrome

Low Anterior Resection Syndrome Clinical Trial

Official title:

Paula Method Muscle Exercises in Patients With Low Anterior Resection Syndrome After Sphincter Sparing Rectal Resection: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016583
• Other study ID #: PAULA-LARS-HMO-CTIL
• Status: Completed
• Phase: N/A
• Start date: October 28, 2021
• Est. completion date: July 4, 2022

Study information

• Verified date: October 2021
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 4, 2022
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over age 18
• LARS syndrome (LARS score of 21 or higher) up to 24 months post sphincter sparing rectal resection
• Able to read, understand and communicate in Hebrew

Exclusion Criteria:

• Pregnancy
• Actively undergoing Chemotherapy or Radiation
• Other causes of anal incontinence or bowel dysfunction (ex: Irritable Bowel Syndrome)
• Concurrent performance of other exercise methods
• Unable or unwilling to perform the Paula exercises

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Syndrome

Intervention

Other:
• Paula Method
12 weeks of Paula Method of Exercises

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Liebergall-Wischnitzer M, Shaphir A, Solnica A, Hochner-Celnikier D. Are Paula method exercises effective for gastrointestinal reactivation post-elective cesarean delivery? Randomized controlled trial. J Adv Nurs. 2021 Apr;77(4):2026-2032. doi: 10.1111/jan.14681. Epub 2020 Nov 29. Erratum in: J Adv Nurs. 2021 Nov;77(11):4598. — View Citation

Nguyen TH, Chokshi RV. Low Anterior Resection Syndrome. Curr Gastroenterol Rep. 2020 Aug 4;22(10):48. doi: 10.1007/s11894-020-00785-z. Review. — View Citation

Nocera F, Angehrn F, von Flüe M, Steinemann DC. Optimising functional outcomes in rectal cancer surgery. Langenbecks Arch Surg. 2021 Mar;406(2):233-250. doi: 10.1007/s00423-020-01937-5. Epub 2020 Jul 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in LARS (Low Anterior Resection Syndrome) Score	Decrease of in the LARS Score from baseline measurement to the end of the study measurement.; The scale is based on a score of 0-42 . A score of 0-20 indicates the absence of LARS, 21-29- Minor LARS, and 30-42- Major LARS.	12 weeks