Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

Study Overview
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Brief Summary
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Fecal incontinence is common in patients with rectal cancer after surgery. Previous studies showed that pelvic floor muscle and external sphincter muscle training after stoma closure could improve the severity of incontinence and other fecal symptoms, but there is no study about the effects of pelvic floor muscle exercise intervention before stoma closure. We are wondering would the symptom of fecal incontinence recover sooner and better if we give the pelvic floor muscle exercise intervention before the stoma closure. This article aims at comparing the effects of pelvic floor muscle training before stoma closure on fecal incontinence (pre-intervention group) with pelvic floor muscle training after stoma closure (post-intervention group), and we hypothesise that the severity of fecal incontinence will improve sooner and better in pre-intervention group.

Official Title
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Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision

Conditions
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Rectal Cancer

Intervention / Treatment
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* Other: pelvic floor muscle exercise before stoma closure
* Other: pelvic floor muscle exercise after stoma closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: rectal cancer patients who have received transanal total mesorectal excision(TaTME) surgery; 20 75 years old Exclusion Criteria: terminal stage of cancer; unable to following orders due to poor cognitive condition; too weak to follow the experimental procedures; central nervous system lesions

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-intervention group<br>Pre-intervention group interventions:pelvic floor muscle training for one month (2 3 times a week, for 4 weeks) just one month before the stoma closure | Other: pelvic floor muscle exercise before stoma closure<br>* pelvic floor muscle training for one month (2 3 times a week, for 4 weeks) just one month before the stoma closure<br>|
| Active Comparator: Post-intervention group<br>Post-intervention group: pelvic floor muscle training for one month (2 3 times a week, for 4 weeks) two weeks after the stoma closure | Other: pelvic floor muscle exercise after stoma closure<br>* pelvic floor muscle training for one month (2 3 times a week, for 4 weeks) just two weeks after the stoma closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of The Wexner Score | for the change of severity of fecal incontinence assessment | measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of St. Mark's Hospital Incontinence Score | for the change of severity of fecal incontinence assessment | measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start | 
| Change of Functional assessment of Cancer Therapy - Colorectal (FACT-C) | for the change of quality of life assessment | measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start |