A Novel Constipation Prevention and Management Protocol Versus Physician-Directed Management of Constipation in Critically Ill Cardiac Patients: A Randomized Controlled Study

Objective: To compare the efficacy of a novel constipation prevention and management protocol with that of routine physician-directed management of constipation in critically ill cardiac patients. Materials and Methods: This randomized controlled trial was conducted in the cardiac care unit and intermediate cardiac care unit of a tertiary hospital in Bangkok, Thailand. A total of 170 patients were randomized and analyzed according to the intention-to-treat principle. Missing outcome data were handled using multiple imputation. The protocol group was further subdivided using the ROME criteria into Group 1 and Group 2 (abnormal patterns; received immediate laxatives) and Group 3 (normal pattern; received laxatives only if no defecation occurred within 48 hours). The primary outcome was enema use. Secondary outcomes included the incidence of constipation and diarrhea, and patient satisfaction. Data were analyzed using appropriate statistical methods. Results: The incidence of enema use was 17.41% in the protocol group and 16.45% in the usual care group. Constipation occurred in 25.41% and 36.94% of patients, respectively, while diarrhea occurred in 1.0% and 1.2%. Patient satisfaction was comparable between groups (p = 0.221). Conclusion: The individualized bowel management protocol did not significantly reduce enema use, constipation, or diarrhea compared with usual care. Exploratory findings suggest that early laxative administration based on defecation patterns may facilitate earlier bowel movement.