Ácido ursodesoxicólico como fator protetor da formação de cálculos biliares em pacientes submetidos a cirurgia bariátrica: estudo clínico randomizado

Abstract

OBJECTIVES: To evaluate the efficacy of ursodeoxycholic acid used for two months as a protective factor against biliary lithogenicity in patients undergoing bariatric surgery. MATERIALS AND METHODS: This is a randomized, prospective, longitudinal clinical study with a quantitative approach and descriptive data analysis. Upper abdominal ultrasound was used as a research tool to assess the formation of gallstones after bariatric surgery. Results were correlated with the administration or non-administration of ursodeoxycholic acid for two months. The cumulative survival curve was constructed using the Kaplan-Meier method. Disease-free survival (gallstones) was defined as the time between the pre-operative ultrasound examination with no gallstones and the date of documented gallstones on ultrasound. The study was approved by the Research Ethics Committee through the Brazil platform, under number CAAE 98802818.0.1001.8167. RESULTS: The sample of 74 patients was divided into an intervention group (47.3%) and a control group (52.7%). In the intervention group, 34.3% were men and 65.7% were women, while in the control group, 25.61% were men and 74.4% were women. The mean pre-surgical weight was 123.06 kg in the intervention group and 118.13 kg in the control group, with an average BMI of 42.34 kg/m² and 41.5 kg/m², respectively. After five years, 34 patients in the intervention group did not develop gallstones, except for one. In the control group, 31 patients had gallstones. The disease-free survival curve indicated 75.24 months for the intervention group and 30.03 months for the control group, with p < 0.001 in the Mantel log-rank test. CONCLUSION: Ursodeoxycholic acid has proven to be effective in significantly reducing gallstones in the intervention group compared to the control, highlighting its importance as a protective agent after bariatric surgery. This study challenges previous paradigms by demonstrating that continuous use of the medication during the first two months post-surgery is crucial to prevent biliary lithogenicity. The social impact is significant, as reducing complications improves patients’ quality of life and alleviates the burden on healthcare systems. Nursing plays a crucial role in ensuring the success of this intervention. Nurses are responsible for educating and guiding patients on the importance of adherence to treatment, supervising the correct administration of medication, and providing ongoing support. This proactive role of nursing not only improves clinical outcomes but also promotes social benefits by empowering patients to manage their health effectively.