Back to resultsEarly Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection
Primary Purpose
Cancer of Rectum
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Pelvic floor exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Rectum focused on measuring Cancer of rectum, Physiotherapy
Eligibility Criteria
Inclusion Criteria:
- Patients who will undergo low anterior resection of rectum
- Patient consented for study
Exclusion Criteria:
- Patient unable to understand pelvic floor exercise
- Patient who underwent alternative procedure
- Patient who suffers anastomotic complications after surgery
- Patient who ileostomy not closed
Sites / Locations
- Department of Surgery, Kwong Wah HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pelvic floor exercise
Control
Arm Description
Outcomes
Primary Outcome Measures
Maximum Squeeze Pressure
Secondary Outcome Measures
Functional Outcomes
Bowel frequency, Fecal incontinence score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01146769
Brief Title
Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection
Official Title
Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kwong Wah Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Rectum
Keywords
Cancer of rectum, Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pelvic floor exercise
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Pelvic floor exercise
Intervention Description
Pelvic floor strengthening exercise
Primary Outcome Measure Information:
Title
Maximum Squeeze Pressure
Time Frame
1 week before operation and 3 months after operation
Secondary Outcome Measure Information:
Title
Functional Outcomes
Description
Bowel frequency, Fecal incontinence score
Time Frame
1 week before operation and 3 months post operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who will undergo low anterior resection of rectum
Patient consented for study
Exclusion Criteria:
Patient unable to understand pelvic floor exercise
Patient who underwent alternative procedure
Patient who suffers anastomotic complications after surgery
Patient who ileostomy not closed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Y LAU, MBBS
Phone
(852) 3517 7919
Email
lauyy01@ha.org.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Y LAU
Organizational Affiliation
Department of Surgery, Kwong Wah Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Kwong Wah Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Lau
Email
lauyy01@ha.org.hk
12. IPD Sharing Statement
Learn more about this trial
Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection
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