Abstract
BackgroundAfter low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of the patient but also on the Dutch National Healthcare budget with more than €2000 spent per patient per year. No standardized treatment is available to help these patients. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50–80%. No strong evidence is available for the use of PFR after LAR. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment.MethodsThe FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness. Baseline measurements take place before randomization. The primary endpoint is measured 3 months after the start of the intervention, with a 1-year follow-up for sustainability research purposes.DiscussionThe results of this study may substantially improve postoperative care for patients with fecal incontinence or anorectal dysfunction after LAR. This section provides insight in the decisions that were made in the organization of this trial.Trial registrationNetherlands Trial Registration, NTR5469, registered on 03-09-2015.Protocol FORCE trial V18, 19-09-2019.Sponsor Radboud University Medical Center, Nijmegen.
Highlights
After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction
Up to 76–90% of these patients report a combination of these complaints, which are described as low anterior resection syndrome (LARS) [2, 3]
To our knowledge, the FORCE trial is the first to study the effects of a structured pelvic floor rehabilitation (PFR) program after sphincter-saving rectal cancer surgery in a prospective randomized controlled trial with a well-defined rehabilitation program that uses all four important parts of pelvic floor training and includes an evaluation of quality of life and cost-effectiveness
Summary
After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50–80%. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment. Combinations of surgery, radiotherapy and/or chemotherapy are responsible for improved survival data Nowadays most of these patients can be treated with a sphincter-saving technique, such as the low anterior resection (LAR). Fecal incontinence especially has a major [1, 4, 5] impact on the physical, psychological, social, and emotional functioning of the patient [3, 6]
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