fecal incontinence urgency and frequency
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures are the Wexner Score and the Fecal Incontinence Quality of Life score (FIQL) . The measurement by the Wexner Score and the FIQL after the interventie (M3) will be the primary outcome. The follow-up measurement (M4 ) is to observe the long term effect of the intervention. (look 8.1 Study endpoints page 26) | — |
Secondary
| Measure | Time frame |
|---|---|
| The economic effects of full implementation of PFR compared to standard treatment in treating FI in patients after LAR, will be determined by a cost effectiveness analysis. (look 8.1 Study endpoints page 26) | — |
Countries
Netherlands