Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome)
NCT Number: NCT06519006
Acronym: CH1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prevention|LARS - Low Anterior Resection Syndrome|Pelvic Floor Disorders|Rectal Cancer|Low Anterior Resection
Interventions: PROCEDURE: Pelvic floor exercise
Sponsor: F. D. Roosevelt University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-04-01
Completion Date: 2026-05
Locations: F.D.Roosevelt University Hospital in Banská Bystrica, Banská Bystrica, 97517, Slovakia

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)

Primary Outcome Measures: The number of participants who develop (or what degree) LAR syndrome with or without pelvic floor exercises after LAR, ascertained by LARS questionnaire., 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: Adherence of patients to prescribed home exercise after surgery, determined by the Exercise Adherence Rating Scale (EARS), 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: Quality of life after LAR measured by WHOQOL - BREF, 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