Pelvic Floor Rehabilitation after Rectal Cancer Surgery: One-year Follow-up of a Multicenter Randomized Clinical Trial (FORCE Trial)

Abstract

Objective: To evaluate the effects of pelvic floor rehabilitation (PFR) after low anterior resection (LAR) at 1-year follow-up. Background: After LAR, with restoration of bowel continuity, up to 90% of patients develop anorectal dysfunction, significantly impacting their quality of life (QoL). However, standardized treatment is currently unavailable. The FORCE trial demonstrated the beneficial effects of PFR after 3 months regarding specific domains of the Fecal Incontinence QoL (FIQL) questionnaire and urgency compared with usual care. Methods: The FORCE trial is a multicenter, two-arm, randomized clinical trial. All patients undergoing LAR were randomly assigned to receive either usual care or a standardized PFR program. The primary outcome measure is the Wexner incontinence score, and the secondary endpoints included the low anterior resection syndrome score, the European Organization for Research and Treatment of Cancer colorectal-specific QoL questionnaire, and health and FIQL. Assessments were conducted at baseline before randomization, at 3 months and 1-year follow-ups. Results: A total of 86 patients were included (PFR: n = 40, control: n = 46). After 1 year, PFR did not significantly improve Wexner incontinence scores (PFR: -3.33, 95% CI: -4.41 to -2.26, control: -2.54, 95% CI: -3.54 to -1.54, P = 0.30). Similar to the 3-month follow-up, patients without near-complete incontinence at baseline showed a sustained improvement in fecal incontinence (PFR: -2.82, 95% CI: -3.86 to -1.76, control: -1.43, 95% CI: -2.36 to -0.50, P = 0.06). Significant improvement was reported in the FIQL domains Lifestyle (PFR: 0.51, control: -0.13, P = 0.03) and Coping and Behavior (PFR: 0.40, control: -0.24, P = 0.01). Trial registration: Netherlands Trial Registration, NTR5469, registered on September 3, 2015. Conclusions: At 1-year follow-up, no significant differences were found in fecal incontinence scores; however, PFR was associated with improved FIQL compared with usual care.