Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome)
NCT ID: NCT06519006
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-04-01
2026-05-31
Brief Summary
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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)
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Surgical procedure - mini-invasive low anterior rectal resection
Exclusion Criteria
* request to practice pelvic floor exercises despite being in the control group
* non-compliance
* serious psychiatric diagnoses
19 Years
ALL
Yes
Sponsors
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F. D. Roosevelt University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ľubomír Marko, MD,ass. prof
Role: STUDY_DIRECTOR
F. D. Roosevelt University Hospital
Barbara Mrázová, MD,MPH
Role: STUDY_CHAIR
F. D. Roosevelt University Hospital
Locations
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F.D.Roosevelt University Hospital in Banská Bystrica
Banská Bystrica, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Asnong A, D'Hoore A, Van Kampen M, Wolthuis A, Van Molhem Y, Van Geluwe B, Devoogdt N, De Groef A, Guler Caamano Fajardo I, Geraerts I. The Role of Pelvic Floor Muscle Training on Low Anterior Resection Syndrome: A Multicenter Randomized Controlled Trial. Ann Surg. 2022 Nov 1;276(5):761-768. doi: 10.1097/SLA.0000000000005632. Epub 2022 Jul 27.
Laforest A, Bretagnol F, Mouazan AS, Maggiori L, Ferron M, Panis Y. Functional disorders after rectal cancer resection: does a rehabilitation programme improve anal continence and quality of life? Colorectal Dis. 2012 Oct;14(10):1231-7. doi: 10.1111/j.1463-1318.2012.02956.x.
Liu CH, Chen CH, Lee JC. Rehabilitation exercise on the quality of life in anal sphincter-preserving surgery. Hepatogastroenterology. 2011 Sep-Oct;58(110-111):1461-5. doi: 10.5754/hge11160. Epub 2011 Jul 15.
Lin KY, Granger CL, Denehy L, Frawley HC. Pelvic floor muscle training for bowel dysfunction following colorectal cancer surgery: A systematic review. Neurourol Urodyn. 2015 Nov;34(8):703-12. doi: 10.1002/nau.22654. Epub 2014 Aug 23.
Pucciani F, Ringressi MN, Redditi S, Masi A, Giani I. Rehabilitation of fecal incontinence after sphincter-saving surgery for rectal cancer: encouraging results. Dis Colon Rectum. 2008 Oct;51(10):1552-8. doi: 10.1007/s10350-008-9312-6. Epub 2008 May 2.
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.
Other Identifiers
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CHIRURGIA2024
Identifier Type: -
Identifier Source: org_study_id
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