A Randomized, Double Blind, Placebo Controlled Study to Study Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 9
- 主要终点
- Measure of Improvement Over the Standard
研究概览
简要总结
The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.
详细描述
Narcotic pain medicines bind mu-opioid receptors in the bowel and delay the return of normal function. Alvimopan is a peripherally acting mu-opioid receptor antagonist that blocks mu-opioid receptors in the gastrointestinal tract but does not compromise central nervous system-mediated opioid-based analgesia. Length of stay is an important surrogate measure of quality after colon surgery and the most common reason for prolonged Length of Stay after abdominal surgery is delayed gastrointestinal recovery (postoperative ileus).
The Food and Drug Administration has approved alvimopan (dosed preoperatively and twice daily postoperatively for up to 15 in-hospital doses) for the acceleration of upper and lower gastrointestinal recovery after partial bowel resection with primary anastomosis. In the 5 phase III alvimopan efficacy trials, a simple standardized accelerated postoperative care pathway was used rather than a comprehensive, multidisciplinary colon surgery care process model that is used by Intermountain Healthcare. In the most recently completed alvimopan phase III trial, the mean postoperative length of stay was 5.2 days whereas the mean length of stay at Intermountain Healthcare is 4.4 days without the addition of alvimopan to the multidisciplinary colon care process model.
This trial will investigate if the addition of alvimopan to the Intermountain Healthcare multidisciplinary care process can decrease length of stay compared with the multidisciplinary care process plus placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs
- •Elective colon/rectal resection with anastomosis as primary procedure
- •Patient enrolled in multidisciplinary colon care process
排除标准
- •Pregnancy or lactation
- •Chronic opioid use or > 3 doses in 7 days prior to surgery
- •History of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome
- •Complete bowel obstruction
- •Patients with end-stage renal disease as defined by the need for dialysis and the commonly accepted threshold for dialysis is a Glomerular Filtration Rate of <
- •Patients with severe hepatic impairment (Childs-Pugh class C)
- •ASA 4 or 5 (ASA 4 s incapacitating systemic disease that is a constant threat to life)
- •Non-English speaking patients
研究组 & 干预措施
300 mg Polyethylene
干预措施: 300 mg Polyethylene (Drug)
Alvimopan
干预措施: Alvimopam (Drug)
结局指标
主要结局
Measure of Improvement Over the Standard
时间窗: Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]
Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date.
次要结局
- Hospital Cost(Upon discharge)