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.

Experience and coping strategies of bowel dysfunction in postoperative patients with rectal cancer: a systematic review of qualitative evidence

“…Burch’s research ( 2021 ) showed that the quality of life of patients after rectal cancer surgery is not high. Pelvic floor muscle function exercise ( Sacomori et al, 2021 ), sacral nerve stimulation ( Kuo et al, 2015 ), biofeedback training ( Liu et al, 2019 ). Which can effectively alleviate patients’ bowel symptoms and improve their quality of life, but there are no high-quality studies that show the most appropriate treatment method.…”

Challenges in evaluating pelvic floor physiotherapy based strategies in low anterior resection syndrome: a systematic review and qualitative analysis

“…The studies commenced interventions at different time points, as summarized in Table 4. One study was pre-habilitative [16], with education and regimes commencing preoperatively. One study was early rehabilitative [15], between resection and stoma reversal, and three studies were rehabilitative [14,17,18] commencing PFP after LAR or stoma reversal.…”

“…One study investigated PFP only [14], three studies included BF and rectal balloon training [16][17][18], while Cho et al [15] compared the efficacy between combined PFP and BF, and PFP alone.…”

The Effect of Pelvic Floor Rehabilitation on Lower Anterior Resection Syndrome After Colorectal Cancer Treatment

“…Preventative PFR has been used extensively outside of colorectal medicine. Since project conclusion, a current literature review now reveals one randomized clinical trial pilot study looking at PFR as a preventative therapy for LARS [29].…”