Paula Method of Exercises in Patients With LARS Syndrome

NCT05016583 | Completed

• 1 other identifier: PAULA-LARS-HMO-CTIL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Anterior Resection Syndrome

Keywords

Paula Method; Sphincter sparing rectal resection; Anal incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Paula Method

EXPERIMENTAL

Other: Paula Method

Interventions

Paula Method OTHER

12 weeks of Paula Method of Exercises

Paula Method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (3)

• Nocera F, Angehrn F, von Flue 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.

  PMID: 32712705 BACKGROUND

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

  PMID: 32749603 BACKGROUND

• 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.

  PMID: 33249611 BACKGROUND

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Encopresis

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 23, 2021
• Study Start: October 28, 2021
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: October 13, 2022

Record last verified: 2021-10

Locations

IL (1)