Yantai

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the effectiveness of mosapride citrate injection in treating postoperative gastrointestinal dysfunction. The study includes adult patients aged 18 to 75 years who have undergone elective laparoscopic-assisted intestinal resection involving parts from the ileocecal region to the sigmoid colon. The trial aims to measure the time until patients first experience flatus after surgery, which is an indicator of gastrointestinal recovery. Participants are randomly assigned to one of three groups: a high-dose mosapride citrate injection group receiving 8 mg intravenously twice daily, a low-dose mosapride citrate injection group receiving 4 mg intravenously twice daily, or a placebo group receiving an intravenous placebo twice daily. The treatment period lasts between 3 to 5 days. Prior to surgery, patients undergo a screening period within 28 days, and after completing treatment, they enter a follow-up phase lasting 7 days. Throughout the study, participants are closely monitored from screening through treatment and follow-up. Researchers assess vital organ function, physical condition, and various laboratory tests to ensure safety and eligibility. The primary outcome is the time to first flatus recorded up to 3 to 5 days postoperatively, which helps evaluate gastrointestinal function recovery. The total participation duration includes the screening, treatment, and follow-up phases to capture comprehensive data on treatment effects and patient safety.