Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Kwong Wah Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kwong Wah Hospital
Information provided by:
Kwong Wah Hospital
ClinicalTrials.gov Identifier:
NCT01146769
First received: June 15, 2010
Last updated: June 17, 2010
Last verified: April 2010
| Tracking Information | |||||
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| First Received Date ICMJE | June 15, 2010 | ||||
| Last Updated Date | June 17, 2010 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Maximum Squeeze Pressure [ Time Frame: 1 week before operation and 3 months after operation ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01146769 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Functional Outcomes [ Time Frame: 1 week before operation and 3 months post operation ] [ Designated as safety issue: No ] Bowel frequency, Fecal incontinence score |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection | ||||
| Official Title ICMJE | Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection | ||||
| Brief Summary | The aim of study is to investigate the difference in Maximum Squeeze Pressure in patients with and without pelvic floor muscle training in low anterior resection in peri-operative period |
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| Detailed Description | The functional outcome after low anterior resection varies greatly. Proportion of patient suffers from urgency and incontinence. Pelvic muscle disuse with atrophy and fibrosis may be a cause for the poor function. Peri-operative pelvic floor muscle training may preserve pelvic floor muscle bulk and function and thus improve functional outcome after surgery. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Cancer of Rectum | ||||
| Intervention ICMJE | Other: Pelvic floor exercise
Pelvic floor strengthening exercise |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | April 2012 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Hong Kong | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01146769 | ||||
| Other Study ID Numbers ICMJE | EMTIMS-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | LAU Patrick YY, Department of Surgery, Kwong Wah Hospital | ||||
| Study Sponsor ICMJE | Kwong Wah Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Kwong Wah Hospital | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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