Pelvic Floor Rehabilitation to improve functional Outcome and quality of life after surgery for Rectal CancEr: a randomized controlled trial (FORCE TRIAL)
Recruiting
- Conditions
- fecal incontinenceurgency and frequency100179771002830210017998
- Registration Number
- NL-OMON47338
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 168
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients underwent low anterior resection for rectal carcinoma
- Age * 18 years
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Comorbidity in history like proctitis, colitis ulcerosa, Crohn disease.
- Locally advanced (T4) tumors indicated for extensive resection (beyond
TME)
- Previous history of pelvic radiation (other than rectal cancer)
- Pelvic Floor Rehabilitation during last 6 months
- Life expectancy < one year
- Mentally or physically not able to undergo the intervention
- No informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measures are the Wexner Score and the Fecal Incontinence<br /><br>Quality of Life score (FIQL) . The measurement by the Wexner Score and the FIQL<br /><br>after the interventie (M3) will be the primary outcome. The follow-up<br /><br>measurement (M4 ) is to observe the long term effect of the intervention.<br /><br><br /><br><br /><br>(look 8.1 Study endpoints page 26)</p><br>
- Secondary Outcome Measures
Name Time Method <p>The economic effects of full implementation of PFR compared to standard<br /><br>treatment in treating FI in patients after LAR, will be determined by a cost<br /><br>effectiveness analysis.<br /><br><br /><br>(look 8.1 Study endpoints page 26)</p><br>