Background: There is scarcity of trials about preventative strategies for low anterior resection syndrome (LARS) in rectal cancer patients. The aim of this study is to evaluate the effectiveness of a pre- and post-surgical pelvic floor rehabilitation program on the bowel symptoms, pelvic floor function, and quality of life of rectal cancer patients.
Methods: A randomized controlled trial with parallel groups (pelvic floor rehabilitation versus control group), with a blinded evaluator.
Participants and setting: 56 stage I to III rectal cancer patients aged from 18 to 80 years old undergoing sphincter preservation surgery at Hospital del Salvador and who have a sufficient knowledge of Spanish.
Main outcome measures: ICIQ-B questionnaire for intestinal symptoms, high-resolution anorectal manometry (Alacer Multiplex 24-channel manometry equipment) for anorectal function, pelvic floor muscle strength test with Oxford Modified Scale, and a quality of life test with the EORTC QLQ C30 questionnaire. The evaluations will be carried out at five stages: before surgery, before and after the pelvic floor rehabilitation, and during a 3-month and 1-year follow-up.
Interventions: one pre-rehabilitation session and 9 to 12 sessions of pelvic floor rehabilitation, including patient education, pelvic floor muscle exercises, pelvic floor electromyography biofeedback, and capacitive and sensory rectal training with a balloon probe. Rehabilitation will begin 3-5 weeks before the ileostomy is removed (four sessions) and around 3 weeks after stoma removal (5-8 sessions).
Discussion: We expect the program to improve the bowel symptoms, pelvic floor function, and quality of life of rectal cancer patients.
Trial registration: Australian New Zealand Clinical Trials Register ACTRN12620000040965 . Registered on 21 January 2020.
Keywords: Bowel symptoms; Low anterior resection syndrome; Pelvic floor; Physiotherapy; Prevention; Quality of life; Rectal cancer; Rehabilitation.
© 2021. The Author(s).