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

Trial Title: Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome)

NCT ID: NCT06519006

Condition: Prevention
LARS - Low Anterior Resection Syndrome
Pelvic Floor Disorders
Rectal Cancer
Low Anterior Resection

Conditions: Official terms:
Rectal Neoplasms
Low Anterior Resection Syndrome
Pelvic Floor Disorders
Syndrome

Conditions: Keywords:
prevention, LARS, pelvic floor exercise, LAR

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Pelvic floor exercise
Description: 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.
Arm group label: Intervention group - specific pelvic floor exercise after LAR

Summary: 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)

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: F.D.Roosevelt University Hospital in Banská Bystrica

Address:
City: Banská Bystrica
Zip: 97517
Country: Slovakia

Status: Recruiting

Contact:
Last name: Barbara Mrázová, MD,MPH

Phone: +421918964357
Email: barbara.mrazova19@gmail.com

Start date: April 1, 2024

Completion date: May 2026

Lead sponsor:
Agency: F. D. Roosevelt University Hospital
Agency class: Other

Source: F. D. Roosevelt University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06519006