Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Postoperative Length of Hospital Stay
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Alvimopan (Drug)
Placebo
Perioperative administration of placebo, at same dosing interval as study drug.
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative Length of Hospital Stay
时间窗: 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
次要结局
- Postoperative Ileus Incidence(Patients will be followed for 30 days postop)
研究者
Jamie N. Bakkum-Gamez
Consultant and Assistant Professor of Obstetrics-Gynecology,
Mayo Clinic