Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome) (CH1)

July 19, 2024 updated by: F. D. Roosevelt University Hospital

Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome) After Mini-invasive Low Anterior Resection in Patients With Rectal Cancer

The main aim of this randomized study will be to determine the effectiveness of pelvic floor exercises on the incidence or severity of LAR syndrome in patients after mini-invasive rectal resection.

The main questions it aims to answer are:

  • Does pelvic floor exercise after low anterior resection prevent LARS (low anterior resection syndrome)?
  • What is the adherence of patients to prescribed home exercise after surgery?
  • Quality of life after LAR

Researchers will compare the group of patients with pelvic floor exercises to those without and determine the occurrence and severity of LARS.

Participants will:

  • under the professional guidance of a physiotherapist, the day before surgery and in the first 4 postoperative days be educated to exercise the pelvic floor
  • continue exercise at home for a month (according to the instructions together with the infographic)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Advances in the surgical treatment of rectal diseases lead to better oncological results, a higher chance of preserving the sphincters, and thus a lower number of permanent stomas. However, the preserved anus does not always have to perform its original function fully. All patients after a low anterior resection of the rectum are at risk of developing functional disorders, the so-called LARS (low anterior resection syndrome). Patients may develop varying degrees of functional anorectal disorder, from urgency, stool incontinence to constipation. The prevalence of LARS ranges from 41-80% and is a significant factor in reducing the quality of life.

The therapy of LAR syndrome, depending on the severity, consists of medication, transanal irrigation, pelvic floor rehabilitation, neurostimulation or surgery. The most effective is a combination of treatment modalities. Given the lack of high-quality evidence in this area, recommendations are generally based on retrospective studies or extrapolated from studies of non-surgical patients with similar gastrointestinal disorders. Suppose the disease is present 1-2 years after the surgery and all treatment modalities are exhausted. In that case, the patient is offered a permanent removal of the stoma, which has a lifelong impact on the patient.

According to the available data, it is possible to prevent the occurrence of LARS through postoperative pelvic floor exercises, however, relevant studies are missing The pelvic floor is a ligament-muscle system that provides dynamic support for the organ systems located in the small pelvis - the urinary system, the genitals, and the intestinal organs.

Exercise of the pelvic floor muscles plays an important role in patients suffering from incontinence, pelvic organ prolapse, or rectal prolapse. Strengthening the muscles can serve as a follow-up treatment after surgical procedures including prevention of LARS.

The resulting knowledge of the possibility of preventing LARS will have a fundamental impact on clinical practice and patient management.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Viktória Durajová, Ing,PhD,MBA
  • Phone Number: +421907312462
  • Email: vdurajova@nspbb.sk

Study Locations

  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • Recruiting
        • F.D.Roosevelt University Hospital in Banská Bystrica
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Cognitive functions make it possible to understand and sign the patient's informed consent and consent to participate in the study
  • Surgical procedure - mini-invasive low anterior rectal resection

Exclusion Criteria:

  • not agreeing to participate in the study
  • request to practice pelvic floor exercises despite being in the control group
  • non-compliance
  • serious psychiatric diagnoses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group - usual management
This arm will be managed as usual - without specific pelvic floor exercises after surgery, and 1, 6 and 12 months after low anterior resection, patients will be questioned about the possible development of LARS.
Experimental: Intervention group - specific pelvic floor exercise after LAR

This arm will be instructed to exercise pelvic floor after low anterior resection for one month and 1, 6, and 12 months postoperatively will be questioned about the possible development of LARS.

One month after surgery they will also be questioned about adherence to prescribed exercise.
Procedure: Pelvic floor exercise
Exercises aimed at this issue consist of identification and isolated contraction of the pelvic floor muscles as well as their activation during complex movements and daily activities. During the engagement of the pelvic floor muscles, the correct engagement of the respiratory activity is important. Within the exercise units, exercises are used from sphincter contraction, through the gradual activation of individual pelvic floor layers in various ways, to their complex involvement in movement activities. Exercises are practiced repeatedly, at different frequencies and intensities that gradually increase, 4-5 times per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of participants who develop (or what degree) LAR syndrome with or without pelvic floor exercises after LAR, ascertained by LARS questionnaire.
Time Frame: 4 weeks
Patients may develop varying degrees of functional impairment - defecation urgency, fecal incontinence, increased frequency of stool, fragmentation and numerous bowel movements in a short period, problems with emptying or incomplete stool evacuation, increased intestinal flatulence, diarrhea, constipation or change in stool consistency. Participants will exercise at home. 1,6,12 months after surgery, the Low Anterior Resection Syndrome (LARS) questionnaire will be sent to patients. LARS questionnaire contains 5 questions about bowel functions. It is officially translated into the Slovak language. Final score range between 0-42. 0-20: NO LARS, 21-29: minor LARS, 30 - 42: major LARS.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence of patients to prescribed home exercise after surgery, determined by the Exercise Adherence Rating Scale (EARS)
Time Frame: 4 weeks
The results can be significantly limited by the patient's actual exercise at home. One month after surgery a 16-item EARS questionnaire using a 5-point Likert scale will be sent to patients. 0 = completely agree to 4 = completely disagree. Summed score range from 0 to 64. Positively phrased items are reversed scored so that a higher overall adherence score indicates better adherence to exercise.
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life after LAR measured by WHOQOL - BREF
Time Frame: 1 - 12 months after LAR
Low anterior resection syndrome is a significant factor reducing the quality of life. 1,6,12 months after surgery the WHO Quality of Life Questionnaire - BREF will be sent to patients. It is a 0-100 scale. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
1 - 12 months after LAR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

F. D. Roosevelt University Hospital

Investigators

  • Study Director: Ľubomír Marko, MD,ass. prof, F. D. Roosevelt University Hospital
  • Study Chair: Barbara Mrázová, MD,MPH, F. D. Roosevelt University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHIRURGIA2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Demographics, diagnosis, TNM stage, histology, complications, questionaires

IPD Sharing Time Frame

5th June 2024 for at least 5 years

IPD Sharing Access Criteria

EU Open Research Repository

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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