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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorF. D. Roosevelt University Hospital

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

not agreeing to participate in the study

request to practice pelvic floor exercises despite being in the control group

non-compliance

serious psychiatric diagnoses

Trial design

Design model

Single group

Treatments tested in this trial

  • Pelvic floor exercise

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Control group - usual managementNo intervention 0 interventions
Group B: Intervention group - specific pelvic floor exercise after LARExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 weeks

Secondary outcomes

1

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.

Time frame
4 weeks

Other outcomes

1

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).

Time frame
1 - 12 months after LAR

Sponsors and contacts

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