Pelvic Floor Rehabilitation to improve functional Outcome and quality of life after surgery for Rectal CancEr: a randomized controlled trial (FORCE TRIAL)
Up to 90% of the patients develop anorectal dysfunctions after a low anterior resection (LAR), which is a sphincter saving technique (3). Especially fecal incontinence has major (1-3) impact on physical, psychological, social and emotional functioning of the patient. (4,5). Alongside, fecal incontinence has a substantial impact on the National Healthcare budget with over €2000 spent per patient per year (6). There is no standardized treatment protocol to help these patients. The standard treatment is focused on symptom relief, consisting of pharmacotherapy like bulking agents and/or anti-diarrhetics. Another treatment is Pelvic floor rehabilitation, one of the most important treatments for fecal incontinence in general, with success rates of 50-80% (7-9).
The FORCE-trial randomizes rectal cancer patients after sphincter saving rectal resection for either a standardized pelvic floor rehabilitation program or standard treatment, in order to reduce complaints and costs of fecal incontinence.
Primary Objective: To evaluate the effect of PFR compared to standard treatment on FI in patients after LAR, by measuring the Wexner-score .
Secondary objective: To analyze the cost effectiveness of full implementation of PFR compared to standard treatment in treating and preventing FI in patients after LAR.
Study design and sample size
The FORCE-trial is a multicentre, two-armed, randomized, clinical trial. After recovery of surgery, patients are randomized for either a standardized PFR program or standard treatment. For this randomized trial a sample size of 84 patients per arm (total 168 patients) will have 80% power to detect both the targeted differences of 5 points on the Wexner-score assuming a withdrawal rate of 50%.
All rectal cancer patients indicated for sphincter saving surgery (low anterior resection or LAR) recruited from the participating hospitals.
Three months after LAR or six weeks after stoma closure the patients from the intervention group will receive, next to the standard treatment, a standardized pelvic floor rehabilitation program, which will consist of 12 sessions performed during 3 months. This pelvic floor rehabilitation will be performed by registered pelvic floor physiotherapists. The patients of the controlgroup will get the standard treatment focused on symptom relief.
Main study parameter/endpoint
To determine the effect of PFR compared to standard treatment on FI in patients after LAR, by measuring the Wexner-score
Secondary study endpoints
The economic effects of full implementation of PFR compared to standard treatment in treating and preventing FI in patients after LAR, will be determined by a cost effectiveness analysis.
Randomization, blinding and treatment allocation
Randomization will be performed 3 months after LAR or 6 weeks after stoma closure. Randomization will be operated by computer using SPSS program. Stratification will be done in variable blocks. The coordinating investigator is responsible for the communication with the patient and the participating Pelvic floor specialized physiotherapists. Optimal blinding is not possible.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Since the measurement consists of a combination of standard measuring methods that do not carry risks with them, it is extremely unlikely that adverse events will occur during this study and is therefore negligible. The patients of intervention group need a good motivation and self-discipline to exercise at home every day and visit the physiotherapist once a week during the 3 months of treatment. So the burden of this treatment is medium. The results of this study may substantially improve care for patients with faecal incontinence after a LAR for rectal cancer. When there will be evidence that PFR is a good treatment for patients with fecal incontinence after rectal cancer surgery the after treatment will change exceptional. BFR will then become a treatment belonging to the standard treatment of these functional problems.