Clinical trial NCT06519006: Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome)
Official title: Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome) After Mini-invasive Low Anterior Resection in Patients With Rectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prevention
LARS - Low Anterior Resection Syndrome
Pelvic Floor Disorders
Rectal Cancer
Low Anterior Resection
Keywords: prevention, LARS, pelvic floor exercise, LAR
Lead sponsor: F. D. Roosevelt University Hospital
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Cognitive functions make it possible to understand and sign the patient\&#39;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

Primary outcomes:
measure: The number of participants who develop (or what degree) LAR syndrome with or without pelvic floor exercises after LAR, ascertained by LARS questionnaire.
timeFrame: 4 weeks
Secondary outcomes:
measure: Adherence of patients to prescribed home exercise after surgery, determined by the Exercise Adherence Rating Scale (EARS)
timeFrame: 4 weeks
Other outcomes:
measure: Quality of life after LAR measured by WHOQOL - BREF
timeFrame: 1 - 12 months after LAR
Locations:
city: Banská Bystrica
country: Slovakia
facility: F.D.Roosevelt University Hospital in Banská Bystrica
Study officials:
affiliation: F. D. Roosevelt University Hospital
name: Ľubomír Marko, MD,ass. prof
role: STUDY_DIRECTOR
affiliation: F. D. Roosevelt University Hospital
name: Barbara Mrázová, MD,MPH
role: STUDY_CHAIR
References:
citation: Allgayer H, Dietrich CF, Rohde W, Koch GF, Tuschhoff T. Prospective comparison of short- and long-term effects of pelvic floor exercise/biofeedback training in patients with fecal incontinence after surgery plus irradiation versus surgery alone for colorectal cancer: clinical, functional and endoscopic/endosonographic findings. Scand J Gastroenterol. 2005 Oct;40(10):1168-75. doi: 10.1080/00365520510023477.
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citation: Emile SH, Garoufalia Z, Barsom S, Horesh N, Gefen R, Zhou P, Wexner SD. Systematic review and meta-analysis of randomized clinical trials on the treatment of low anterior resection syndrome. Surgery. 2023 Jun;173(6):1352-1358. doi: 10.1016/j.surg.2023.02.010. Epub 2023 Apr 1.