A randomized, multi-center, double-blinded trial is underway to study or placebo.
One group will be given a 12-mg dose of alvimopan 30-90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on postoperative Day 1 after nasogastric tube (NGT) removal until hospital discharge or for a maximum of 7 days (up to 15 doses). The other group will be given a similarly colored 12-mg placebo capsule 30-90 minutes on the same schedule.
Primary outcomes will include the length of time (hrs/days) for recovery of the GI tract, measured by time to first flatus and time to first bowel movement, both measured twice daily. In addition, toleration of diet and oral pain medication will be measured. Variables such as NGT insertion, diet restriction or reductions, episodes of emesis, bloating, and pain will be recorded twice daily.
Secondary outcomes include length of hospital stay, 30-day morbidity and hospital readmission. Postoperative pain scores will be obtained during the hospital stay, and 2 weeks and 30 days postoperatively and the Hernia-Related Quality-of-Life Survey (HerQLes) will also be administered postoperatively.
The study is sponsored by the Medical College of Wisconsin in collaboration with Merck Sharp and Dohme Corp.
Find more information on the “Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair (NCT02379858),” at www.clincaltrials.gov.
tborden@mdedge.com
SOURCE: Clinicaltrials.gov, NCT02379858.