Randomised clinical trial: prucalopride, a colonic pro‐motility agent, reduces the duration of post‐operative ileus after elective gastrointestinal surgery

Summary Background Previous studies have shown that recovery of colonic transit is a major determinant of post‐operative ileus and clinical recovery after gastrointestinal surgery. Prucalopride is a highly selective 5‐hydroxytryptamine receptor‐4 agonist with colonic pro‐motility effects. Aim To evaluate the effect and safety of prucalopride on post‐operative ileus and surgical outcomes after elective gastrointestinal surgery. Methods In this phase II randomised clinical trial, 110 patients undergoing elective gastrointestinal surgery were randomised to either oral prucalopride (2 mg/day) ( n = 55) or placebo ( n = 55). Intervention was started 24 h after surgery and stopped after defecation or maximally at 7 days. The primary outcome was time to defecation. Secondary outcomes included time to first passage of flatus, tolerance of solid food, nasogastric tube reinsertion, post‐operative length of stay, hospital readmission, overall cost, time to walk independently, surgical complications and inflammatory parameters. Results Patients who received prucalopride had a shorter time to defecation (65.0 vs. 94.5 h, P = 0.001), passage of flatus (53.0 vs. 73.0 h, P < 0.001), and post‐operative length of stay (7.0 vs. 8.0 days, P = 0.001) than controls. The number of patients with prolonged ileus (>5 days) (16.4% vs. 34.5%, P = 0.026) and the C‐reactive protein level on post‐operative day 5 (35.67 vs. 59.07 mg/L, P = 0.040) were lower in the prucalopride group. There was no significant difference in post‐operative Clavien–Dindo grade III and IV complications ( P = 0.606) between the groups. Conclusion Prucalopride is a safe and effective treatment to reduce post‐operative ileus and systemic inflammation without affecting post‐operative complications in patients undergoing elective gastrointestinal surgery. ClinicalTrials.gov: NCT 02004652.