At a glance
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A Randomized Controlled Trial of the Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery: A Pilot Study
In Brief
A Phase 4 clinical trial evaluating Simethicone and Oral Suspending Vehicle for Postoperative Ileus and Ileus. Completed, enrolled 100 participants across 2 sites.
Detailed Summary
Post-operative ileus is a common complication following abdominal surgery. It results in abdominal distension, nausea and vomiting as well as abdominal pain. Furthermore, this results in prolonged hospital stay and occasionally readmission following abdominal surgery.The etiology of post-operative ileus is multifactorial and studies evaluating potential treatment options are abundant, though few reliable interventions exist. This study proposal describes a double-blinded randomized controlled trial investigating the effect of simethicone on post-operative ileus in patients undergoing colorectal surgery.
Study Details
Timeline
Interventions
Pharmacological category: antiflatulent 160mg Simethicone orally, 4 times a day for the first five postoperative days
ORA-Plus is an aqueous-based vehicle. Identical to the test drug formulation except for being pharmacologically inert. 160mg Ora-Plus orally, 4 times a day for the first five postoperative days