A Randomized, Double-blind, Single-Center Trial of Alvimopan (Entereg) Versus Placebo in Patients Undergoing Radical Cystectomy and Urinary Diversion on an Enhanced Recovery After Surgery ERAS Protocol
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Time to Return of Bowel Function
研究概览
简要总结
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper [first toleration of solid food] and lower [first bowel movement] gastrointestinal recovery) compared to placebo.
详细描述
A prospective, randomized, single-center double blind trial of Alvimopan versus placebo for improving patient outcomes and cost during radical cystectomy and urinary diversion will be performed. A randomized trial is necessary to control for all the known and unknown confounders associated with instituting this novel intervention into a surgical procedure. We will recruit 136 subjects (63 patients in each arm of the study per sample size calculation below, plus additional 10 subjects to account for drop outs). A control group will be administered a placebo in order to directly compare if the Alvimopan intervention is effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind design.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing radical cystectomy and urinary diversion via open or robotic approach.
- •Man or woman between the ages of 18 and
- •American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4
- •Ileal conduit or ileal neobladder urinary diversion
- •Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent
- •Exclusion criteria:
- •Patients who met any of the following criteria were excluded from participating in the study:
- •Scheduled for a partial cystectomy
- •Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
- •More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery
- •Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed.
- •Pregnant (identified by a positive serum pregnancy test administered after the initial screening process and before the commencement of study activities) or lactating, or not postmenopausal (no menses for at least 1 year) and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam; or abstinence) (Participants will be asked to use birth control for the entire study and for at least 2 weeks after the last dose of study drug.)
- •Participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study
- •Clinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgery
- •Using illicit drugs or abusing alcohol
- •History of previous surgeries, illness, or behavior (eg, depression, psychosis) that in the opinion of the investigator might have confounded the study results or might have posed additional risk in administering the study procedures
- •Patients with severe dementia (as determined from medical records and history. Severe dementia will be defined as dementia that impacts daily functioning.)
- •Patients with severe hepatic impairment.
- •Patients with end-stage renal disease.
- •Patients with heart failure. .
- •Patients with complete gastrointestinal obstruction.
排除标准
- 未提供
研究组 & 干预措施
Oral Alvimopan
Oral Alvimopan (Entereg, Merck) 12 mg between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing) until hospital discharge or a maximum of 7 days (15 in-hospital doses).
干预措施: Alvimopan (Drug)
Matching Placebo
Matching placebo between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing) until hospital discharge or a maximum of 7 days (15 in-hospital doses).
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Return of Bowel Function
时间窗: From Day of surgery (Day 0) to Day 30
To achieve quicker time to return bowel function measured by a composite endpoint of both upper GI recovery (GI-2 recovery = \[first toleration of solid food\] and lower (first bowel movement) gastrointestinal recovery, taking Alvimopan during radical cystectomy, compared to placebo.
次要结局
- Post-operative Length of Stay(Day of surgery (Day 0) to Day of Discharge (Up to Day 30))
- Cost Analysis(Day of surgery (Day 0) to Day 30)
- 30 Day Complications(Day of surgery (Day 0) to Day 30)
- Readmission to Hospital(Day of Discharge (Up to Day 30))
- Post-operative Morbidity(During hospitalization up to 7 days after surgery)
- Open vs Robotic Radical Cystectomy(Day of Surgery (Day 0))
研究者
Mark Preston
Urological Surgeon
Brigham and Women's Hospital