Accelerating Gastrointestinal Recovery
Phase 3
Completed
- Conditions
- Fallopian Tube CancerOvarian CancerPeritoneal Cancer
- Interventions
- Drug: Placebo
- Registration Number
- NCT01704651
- Lead Sponsor
- Jamie N. Bakkum-Gamez
- Brief Summary
This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 146
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Perioperative administration of placebo, at same dosing interval as study drug. Alvimopan Alvimopan Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
- Primary Outcome Measures
Name Time Method Postoperative Length of Hospital Stay Patients will be followed for the duration of their hospital stay, an expected average of 5 days Length of stay = date/time of hospital dismissal - date/time of end of surgery
- Secondary Outcome Measures
Name Time Method Postoperative Ileus Incidence Patients will be followed for 30 days postop Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States