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.

(look Introduction and rationale page 13)

Primary Objective:
To evaluate the effect of PFR compared to standard treatment on FI in patients
after LAR, by measuring the Wexner-score and the Fecal Incontinence Quality of
Life Score (FIQL-score).

Secondary objective:
To analyse the cost effectiveness of full implementation of PFR compared to
standard treatment in treating and preventing FI in patients after LAR.

(look Objectives page 14)

The FORCE-trial is a multicenter, two-armed, randomized, clinical trial.

Rectal cancer patients (>18 year) indicated for sphincter saving rectal
resection (LAR) are eligible for inclusion in this trial. After recovery of
surgery, patients are randomized for either a standardized pelvic floor
rehabilitation (PFR) program or standard treatment. The study flow-chart is
depicted in figure 1. Patients will be recruited in the participating hospitals.
Three months after LAR or 6 weeks after stoma closure randomization will take
place and patients will be divided in two groups: intervention group and
control group. The intervention group wil be treated by selected and
registered pelvic floor specialized physiotherapists and the treatment consists
of pelvic floor rehabilitation. The controlegroep will be treated with the
standard treatment (bulking agents and/or diarhoe inhibitors)
Measuring will take place by questionnaires, Wexner score en FIQL score ,
derived from the DeFeC score and patients will also be asked to undergo
anorectal function tests. This will take place before surgery (M1), 3 months
after LAR or 6 weeks after stoma closure (M2), after intervention (M3) and also
after one year to measure the long term effect of the treatment (M4).
The sample size of this study is 168 (84 per arm)

(look Study design page 15, Study duration page 16 and Sample size calculation
page 19).

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 physiotherapist are selected
based on educationlevel and registration (KNGF-NVFB register), location (around
the four participating hospitals) and experience with treatment equipment
(MAPLe Novuqare).
This treatment is protocolled and consists of four modalities:
1) Pelvic floor muscle training to improve maximum force, lengthening of
contraction period and better timing and coordination of contraction.*
2) Biofeedback is a behavior therapy to give the patient insight in the
contraction and relaxation of the pelvic floor muscles by using an anal
electromyographic probe.*
3) Electrostimulation can improve the effectiveness of the contractionstrength
of the pelvic floor muscles and anal sphincter, using the same anal
electromyographic probe as for biofeedback.*
4) Rectal balloon training to simulate urgency to defecate. By this method the
retaining of stool and capacity of the rectum can be trained.

(look Chapter 5 Treatment page 20-23)

The risk of the current study is negligible.
The patients of intervention group need a good motivation, cooperation to
follow the complete trajectory of treatment of 3 months and there has to be a
good willingness and self-discipline to exercise in home situation every day.
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 be a
treatment belonging to the standard treatment of these functional problems.