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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05016583
Other study ID # PAULA-LARS-HMO-CTIL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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