TY - JOUR
T1 - Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer
T2 - study protocol for a randomized controlled trial (FORCE trial)
AU - FORCE Trial Grp
AU - Kalkdijk-Dijkstra, A. J.
AU - van der Heijden, J. A. G.
AU - van Westreenen, H. L.
AU - Broens, P. M. A.
AU - Trzpis, M.
AU - Pierie, J. P. E. N.
AU - Klarenbeek, B. R.
PY - 2020/1/28
Y1 - 2020/1/28
N2 - Background: After 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. Methods: The 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. Discussion: The 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 registration: Netherlands Trial Registration, NTR5469, registered on 03-09-2015. Protocol FORCE trial V18, 19-09-2019. Sponsor Radboud University Medical Center, Nijmegen.
AB - Background: After 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. Methods: The 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. Discussion: The 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 registration: Netherlands Trial Registration, NTR5469, registered on 03-09-2015. Protocol FORCE trial V18, 19-09-2019. Sponsor Radboud University Medical Center, Nijmegen.
KW - Quality of life
KW - Fecal incontinence
KW - Low anterior resection
KW - Pelvic floor rehabilitation
KW - Functional outcomes
KW - Low anterior resection syndrome
KW - Rectal cancer
KW - SPHINCTER-SAVING SURGERY
KW - LOW ANTERIOR RESECTION
KW - FECAL INCONTINENCE
KW - COLORECTAL-CANCER
KW - BIOFEEDBACK
KW - INSTRUMENT
KW - CONTINENCE
KW - EXERCISE
KW - SCALE
U2 - 10.1186/s13063-019-4043-7
DO - 10.1186/s13063-019-4043-7
M3 - Article
VL - 21
JO - TRIALS
JF - TRIALS
SN - 1745-6215
IS - 1
M1 - 112
ER -