Rectal CancerNCT03120104
Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision
A study testing pelvic floor muscle exercise before stoma closure and pelvic floor muscle exercise after stoma closure in people with Rectal Cancer, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- pelvic floor muscle exercise before stoma closure and pelvic floor muscle exercise after stoma closure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2017to Feb 2019
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- rectal cancer patients who have received transanal total mesorectal excision(TaTME) surgery; 20~75 years old
Who cannot join
- terminal stage of cancer; unable to following orders due to poor cognitive condition; too weak to follow the experimental procedures; central nervous system lesions
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University)
Taipei
Pin Li, +886-988-259-482, 101476@w.tmu.edu.tw
Pin Li
About this study
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.
- Conditions
- Rectal Cancer
- Being tested
- pelvic floor muscle exercise before stoma closure, pelvic floor muscle exercise after stoma closure
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor muscle exercise before stoma closureOther
pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) just one month before the stoma closure
pelvic floor muscle exercise after stoma closureOther
pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) just two weeks after the stoma closure
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention group | Active comparator | 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 Receives: Other: pelvic floor muscle exercise before stoma closure |
| Post-intervention group | Active comparator | Post-intervention group: pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) two weeks after the stoma closure Receives: Other: pelvic floor muscle exercise after stoma closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of The Wexner Score
for the change of severity of fecal incontinence assessment
Measured: measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start
Secondary outcomes (2)
Change of St. Mark's Hospital Incontinence Score
for the change of severity of fecal incontinence assessment
Measured: 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
Measured: measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startJun 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pin Li, Principal investigator, Rehabilitation Department of Taipei Municipal WanFang Hospitial (Managed by Taipei Medical University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120104
- Sponsor's protocol ID
- N201610007
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision
- ClinicalTrials.gov ID
- NCT03120104
- Acronym / sponsor ID
- N201610007
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 19 Apr 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention group | Active comparator | Other: pelvic floor muscle exercise before stoma closurePre-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 |
| Post-intervention group | Active comparator | Other: pelvic floor muscle exercise after stoma closurePost-intervention group: pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) two weeks after the stoma closure |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- rectal cancer patients who have received transanal total mesorectal excision(TaTME) surgery; 20~75 years old
Key exclusion criteria (1 listed)
- terminal stage of cancer; unable to following orders due to poor cognitive condition; too weak to follow the experimental procedures; central nervous system lesions
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 muscle exercise before stoma closurepelvic floor muscle training for one month (2~3 times a week, for 4 weeks) just one month before the stoma closure | Other | Pre-intervention group |
| pelvic floor muscle exercise after stoma closurepelvic floor muscle training for one month (2~3 times a week, for 4 weeks) just two weeks after the stoma closure | Other | Post-intervention group |
Primary outcome
Change of The Wexner Score
Time frame: measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start
for the change of severity of fecal incontinence assessment
2 secondary outcomes
Change of St. Mark's Hospital Incontinence Score
Time frame: 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)
Time frame: measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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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.
Pin Li principal investigator
Rehabilitation Department of Taipei Municipal WanFang Hospitial (Managed by Taipei Medical University)
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 muscle exercise before stoma closure and pelvic floor muscle exercise after stoma closure in people with Rectal Cancer, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 19 Apr 2017. 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 Taiwan. 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 Pin Li (+886-988-259-482, 101476@w.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of The Wexner Score (time frame: measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2017.