Study of Pyridostigmine to Treat Postoperative Ileus After Colorectal Surgery A Double-Blind, Placebo-Controlled Randomized Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of pyridostigmine as a rescue treatment for postoperative ileus in patients who have undergone elective colorectal surgery. This randomized, double-blind, placebo-controlled trial involves adults with benign or malignant colonic or rectal disease who develop postoperative ileus, characterized by symptoms like bloating and absence of bowel movements for at least 48 hours after surgery. The study aims to compare pyridostigmine with placebo alongside standard care to better understand its impact on bowel function recovery. Participants will be randomly assigned to one of two groups one receiving 60 mg of oral pyridostigmine bromide every 12 hours, and the other receiving an oral starch placebo every 12 hours. Treatment will continue from the time postoperative ileus is diagnosed until the return of bowel function or for a maximum of 48 hours. Side effects will be monitored using a specific side effects scale completed at enrollment and after each dose. During the study, participants will be closely monitored for the time until the first passage of gas and stool, tolerance of solid food, and any complications or need for re-operation or hospital readmission within 30 days after surgery. Safety assessments include surveys for side effects after each dose. The total participation period includes follow-up for up to 30 days to capture important recovery and complication outcomes related to postoperative ileus treatment.

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery