FORCE (1-year follow-up)
Trial question
What is the effect of pelvic floor rehabilitation in patients with low anterior resection for rectal cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 86
86 patients (33 female, 53 male).
Inclusion criteria: adult patients with low anterior resection for rectal cancer.
Key exclusion criteria: IBD; life expectancy < 1 year; locally advanced tumors that required extensive resections and could possibly experience worse functional outcomes; previous participation in biofeedback therapy during the past 6 months.
Interventions
N=40 pelvic floor rehabilitation (standardized pelvic floor rehabilitation program consisting of pelvic floor muscle training, biofeedback, functional electrostimulation, and rectal balloon training).
N=46 usual care (regular postoperative care, such as use of bulking agents and advice on lifestyle, fluid intake, use of fibers, diet, and toilet posture).
Primary outcome
Reduction in Wexner incontinence score at 1 year
3.33 points
2.54 points
3.3 points
2.5 points
1.7 points
0.8 points
0.0 points
Pelvic floor
rehabilitation
Usual
care
No significant
difference ↔
No significant difference in reduction in Wexner incontinence score at 1 year (3.33 points vs. 2.54 points; MD 0.79, 95% CI -0.69 to 2.27).
Secondary outcomes
Significantly greater improvement in fecal incontinence-related QoL scores-lifestyle domain at 1 year (0.51 points vs. -0.13 points; MD 0.64, 95% CI 0.06 to 1.22).
Significantly greater improvement in fecal incontinence-related QoL scores-coping and behavior domain at 1 year (0.4 points vs. -0.24 points; MD 0.64, 95% CI 0.15 to 1.13).
Significantly greater improvement in fecal incontinence-related QoL scores-lifestyle domain at 1 year, patients with at least moderate incontinence at baseline (0.73 points vs. 0.14 points; MD 0.59, 95% CI 0 to 1.18).
Conclusion
In adult patients with low anterior resection for rectal cancer, pelvic floor rehabilitation was not superior to usual care with respect to reduction in Wexner incontinence score at 1 year.
Reference
N M Bosch, A J Kalkdijk-Dijkstra, H L van Westreenen et al. Pelvic Floor Rehabilitation After Rectal Cancer Surgery One-year follow-up of a Multicenter Randomized Clinical Trial (FORCE trial). Ann Surg. 2024 Jun 20;281(2):235-242. Online ahead of print.
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