Abstract
BACKGROUND: Different degrees of defecation dysfunction have emerged after the sphincter-saving surgery, which has made a significant influence on the quality of life of patients. Although diet adjustments were shown to be important for the management of defecation dysfunction, studies on the dietary management measures for defecation dysfunction after the sphincter-saving surgery are still scarce. This study aims to evaluate the effects of a "remote precise diet management intervention program" on patients with defecation dysfunction after the sphincter-saving surgery, providing a theoretical basis for clinical implementation of feasible diet management, and ultimately improving the quality of life of patients after the sphincter-saving surgery. METHODS: This study will be a single-center, prospective, randomized controlled, non-blind trial involving rectal cancer patients after sphincter-saving surgery in a three tertiary general hospital who will be randomized into two groups. The intervention group will apply the "remote precise diet management intervention program" including one-on-one dietary instructions, a written booklet, app-assisted dietary recording and planning, and three times remote consolidating instructions and supervision every 2 weeks. The control group will receive a booklet that contains the same information as that provided in the "remote precise diet management program" and receive the standard counseling that is routinely provided by this hospital about the postoperative diet and Management of bowel symptoms. The intervention will begin from discharge until 6 months after surgery. The primary outcome will be the incidence of LARS after the sphincter-saving surgery. The secondary outcome is the quality of life and the dietary intake of participants after surgery. The occurrence of LARS will be evaluated by the Low Anterior Resection Syndrome Score (LARSS), quality of life, and dietary intake will be separately evaluated by the EORTC-QLQ-C30 questionnaire and Food Frequency Questionnaire(FFQ). Data will be collected three times: the baseline, 3rd month, and 6th month. Statistical analysis will be used to compare the outcomes between groups. Generalized estimating equations (GEEs) will be performed to evaluate the overall effect of the intervention on the incidence of LARS, quality of life, and dietary intake. DISCUSSION: The "remote precise diet management intervention program" in this study is designed with the characteristics of scientificity, precision, and feasibility aiming at controlling the bowel symptoms of patients after the sphincter-saving surgery. The findings of the study will provide a theoretical basis for the clinical implementation of feasible diet management, find effective ways to control defecation dysfunction, and ultimately improve the quality of life of patients after the sphincter-saving surgery. TRIAL REGISTRATION: This study has been registered in the Chinese Clinical Trial Registry on March 22nd 2024 (the registration number is ChiCTR2400082167).