The risk of surgical site infection of oral sulfate tablet versus sodium picosulfate for bowel preparation in colorectal cancer surgery: a randomized clinical trial.

ABSTRACT

Purpose: Oral sulfate tablets are abundantly used for bowel preparation before colonoscopy. However, their efficiency and safety for bowel preparation before colorectal surgery remain ill-defined. Herein, we aimed to compare the surgical site infection rates and efficiency between oral sulfate tablets and sodium picosulfate. Methods: We designed a prospective, randomized, phase 2 clinical trial. Patients with colorectal cancer aged 19-75 years who underwent elective bowel resection and anastomosis by minimally invasive surgery were administered oral sulfate tablets or sodium picosulfate. Eighty-three cases were analyzed from October 2020 to December 2021. Surgical site infection within 30 days after surgery was considered the primary endpoint. Postoperative morbidities, the degree of bowel cleansing, and tolerability were the secondary endpoints. Results: Surgical site infection was detected in 1 patient (2.5%) in the oral sulfate tablet group and 2 patients (4.7%) in the sodium picosulfate group, indicating no significant difference between the 2 groups. Postoperative morbidity and the degree of bowel cleansing bore no statistically significant differences. Furthermore, none of the investigated tolerability criteria, namely bloating, pain, nausea, vomiting, and discomfort, differed significantly between the 2 groups. The patients' willingness to reuse the drug was also not significantly different between the 2 groups. Conclusion: Although we could not establish the noninferiority of oral sulfate tablets to sodium picosulfate, we found no evidence suggesting that oral sulfate tablets are less safe or tolerable than sodium picosulfate in preoperative bowel preparation.