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

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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.pdf (999.89 KB)
Date
2021-01
Authors
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http://orcid.org/0000-0002-7349-7850
 https://doi.org/10.1186/s13063-021-05396-1
Journal Title
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Volume Title
Publisher
BMC
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1745-6215
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URI
http://hdl.handle.net/20.500.12254/2166
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– 5weeks 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.
Description
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This study will be funded by CONICYT/ANID [National Research and Development Agency], FONDECYT INICIACIÓN PROGRAM Award Number: 11191016 [National Fund for Scientific and Technological Development Research Initiation Program], Government of Chile. The funding body will not influence the design of the study; the collection, analysis, and interpretation of data; and the writing of the manuscript, which should be declared.
Citation
Trials, Vol. 22, N° 448 (2021) p. 1-11
Keywords
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Atribución-NoComercial-CompartirIgual 3.0 Chile (CC BY-NC-SA 3.0 CL)
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http://creativecommons.org/licenses/by-nc-sa/3.0/cl/
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