A randomized clinical trial to assess the effectiveness of pre- and post-surgical pelvic floor physiotherapy for bowel symptoms, pelvic floor function, and quality of life of patients with rectal cancer: CARRET protocol

Abstract 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