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Pelvic Floor Rehabilitation to improve functional Outcome and quality of life after surgery for Rectal CancEr: a randomized controlled trial (FORCE TRIAL)

Pelvic Floor Rehabilitation to improve functional Outcome and quality of life after surgery for Rectal CancEr: a randomized controlled trial (FORCE TRIAL) - FORCE TRIAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47338
Enrollment
168
Registered
2017-05-31
Start date
2017-10-10
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fecal incontinence urgency and frequency

Interventions

The treatment of the patients of the intervention group consists of 12 treatment sessions by a registered pelvic floor specialized physiotherapist during 12 weeks. These pelvicfloor specialized phys

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)