A Prospective Randomized Control Trial of The Effectiveness of Alvimopan as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Hospital Length of Stay
研究概览
简要总结
This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients undergoing colorectal or small bowel resection who develop POI, and its safety and effectiveness in reducing LOS and POI duration.
This will be a prospective randomized control trial with a total of 58 patients, 29 in each group. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized at the time of diagnosis of postoperative ileus to receive Alvimopan as rescue therapy or to receive conservative standard care.
Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function.
详细描述
This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients undergoing colorectal or small bowel resection who develop POI, and its safety and effectiveness in reducing LOS and POI duration.
Hypothesis:
The investigators hypothesize that the use of alvimopan as rescue therapy in patients undergoing colorectal and small bowel resection surgery who develop POI can shorten their duration of POI and hospital length of stay.
Objectives:
To perform a prospective RCT to evaluate the effect of alvimopan as rescue therapy compared to standard of care in reducing the duration of post-operative ileus and post-operative LOS after colorectal and small bowel resection surgery.
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
- None
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
- •Subjects who have benign or malignant colonic or rectal disease that have undergone laparoscopic or open colorectal resection, small bowel resection or ileostomy reversal with small bowel resection and subsequently developed postoperative ileus, defined as:
- •a. Patients with symptoms of bloating with or without nausea and vomiting, with absence of passage of flatus or stool who require either
- •i. Return to NPO status after initial diet attempts
- •ii. Undergo placement of a nasogastric tube
- •b. Patients with absence of passage of flatus or stool who are either
- •i. More than 5 days after open surgery without recovery of GI function
- •ii. More than 3 days after laparoscopic surgery or ileostomy closure without recovery of GI function
- •Subjects who are 18 years of age and older
- •Subjects of either gender
- •Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.
排除标准
- •Subjects who received Alvimopan preoperatively.
- •Subjects that have taken therapeutic doses of opioids for more than 7 days immediately prior to surgery.
- •Subjects with severe hepatic impairment.
- •Subjects with end-stage renal disease.
- •Subjects who are pregnant.
- •Subjects who have undergone imaging suggesting a small bowel obstruction.
- •Subjects with a medical condition that may interfere with the use of the study medication Alvimopan.
- •Subjects who have a condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study
研究组 & 干预措施
Alvimopan Group
Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function.
All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
干预措施: Alvimopan (Drug)
结局指标
主要结局
Hospital Length of Stay
时间窗: up to 30 days
Number of days from postoperative ileus diagnosis until discharge from hospital
次要结局
- Time to Return of Bowel Function(up to 30 days)
- Number of Participants With Re-operation(within 30 days of surgery)
- Number of Participants With Re-admissions(up to 30 days)
研究者
Scott Steele
Principle Investigator
The Cleveland Clinic