Abstract
BackgroundThere 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.MethodsA 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).DiscussionWe expect the program to improve the bowel symptoms, pelvic floor function, and quality of life of rectal cancer patients.Trial registrationAustralian New Zealand Clinical Trials Register ACTRN12620000040965. Registered on 21 January 2020.
Highlights
Background and rationale {6a} Rectal cancer is a recognized health problem that compromises patients’ health-related quality of life
The prevalence of rectal cancer survivorship is increasing with the improvement of treatments, and surgery with radio-chemotherapies has significantly improved oncological outcomes [2]
This paper presents a protocol for a prospective randomized controlled trial to study the effectiveness of pelvic floor pre(re)habilitation both prior to and after a low anterior resection for rectal cancer, versus no rehabilitation at all, on bowel symptoms, pelvic floor function, and quality of life
Summary
Background and rationale {6a} Rectal cancer is a recognized health problem that compromises patients’ health-related quality of life. The partial or total loss of the rectal reservoir and its replacement with the remaining colon is associated with functional sequelae [4], triggering a negative effect on the pelvic floor region with compromises in evacuation and urinary function. This has been recently investigated and termed as “low anterior resection syndrome” (LARS) [4, 5]. 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
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