PreventionCH1NCT06519006
Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome)
A study testing Pelvic floor exercise in people with Prevention and LARS - Low Anterior Resection Syndrome, run by F. D. Roosevelt University Hospital at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention, LARS - Low Anterior Resection Syndrome, Pelvic Floor Disorders
- What is being tested?
- Pelvic floor exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Apr 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
F.D.Roosevelt University Hospital in Banská Bystrica
Banská Bystrica, 97517
Barbara Mrázová, MD,MPH, +421918964357, barbara.mrazova19@gmail.com
About this study
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
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:
Read more
- 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)
Read the 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.
- Conditions
- Prevention, LARS - Low Anterior Resection Syndrome, Pelvic Floor Disorders, Rectal Cancer, Low Anterior Resection
- Being tested
- Pelvic floor exercise
- Keywords
- prevention, LARS, pelvic floor exercise, LAR
- Medical subject headings
- Low Anterior Resection Syndrome, Pelvic Floor Disorders, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exerciseProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group - usual management | No intervention | 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. |
| Intervention group - specific pelvic floor exercise after LAR | Experimental | 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. Receives: Procedure: Pelvic floor exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Apr 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F. D. Roosevelt University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ľubomír Marko, MD,ass. prof, Study director, F. D. Roosevelt University HospitalBarbara Mrázová, MD,MPH, Study chair, F. D. Roosevelt University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519006
- Sponsor's protocol ID
- CHIRURGIA2024
- Acronym
- CH1
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographics, diagnosis, TNM stage, histology, complications, questionaires
Publications
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.
PubMed 16165701Asnong 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.
PubMed 35894434Laforest 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.
PubMed 22268662Liu 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.
PubMed 21940307Lin 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.
PubMed 25156929Pucciani 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.
PubMed 18452041Emile 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.
PubMed 37012144
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06519006
- Acronym / sponsor ID
- CH1 / CHIRURGIA2024
- Conditions
- Prevention, LARS - Low Anterior Resection Syndrome, Pelvic Floor Disorders, Rectal Cancer, Low Anterior Resection
- Keywords
- prevention, LARS, pelvic floor exercise, LAR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- F. D. Roosevelt University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - usual management | No intervention | –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. |
| Intervention group - specific pelvic floor exercise after LAR | Experimental | Procedure: Pelvic floor exerciseThis 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- not agreeing to participate in the study
- request to practice pelvic floor exercises despite being in the control group
- non-compliance
- serious psychiatric diagnoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor exerciseExercises 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. | Procedure or surgery | Intervention group - specific pelvic floor exercise after LAR |
Primary outcome
The number of participants who develop (or what degree) LAR syndrome with or without pelvic floor exercises after LAR, ascertained by LARS questionnaire.
Time frame: 4 weeks
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.
1 secondary outcome
Adherence of patients to prescribed home exercise after surgery, determined by the Exercise Adherence Rating Scale (EARS)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Background: PubMed 16165701Allgayer 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.
- Background: PubMed 35894434Asnong 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.
- Background: PubMed 22268662Laforest 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.
- Background: PubMed 21940307Liu 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.
- Background: PubMed 25156929Lin 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.
- Background: PubMed 18452041Pucciani 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.
- Background: PubMed 37012144Emile 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.
- Individual participant dataSharing planned: Yes. Demographics, diagnosis, TNM stage, histology, complications, questionaires
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ľubomír Marko, MD,ass. prof study director
F. D. Roosevelt University Hospital
Barbara Mrázová, MD,MPH study chair
F. D. Roosevelt University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor exercise in people with Prevention and LARS - Low Anterior Resection Syndrome, run by F. D. Roosevelt University Hospital at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Mrázová, MD,MPH (+421918964357, barbara.mrazova19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants who develop (or what degree) LAR syndrome with or without pelvic floor exercises after LAR, ascertained by LARS questionnaire. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06519006, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.