A Prospective Randomized Control Trial of The Effectiveness of Entereg as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Hospital Length of Stay
研究概览
简要总结
This will be a prospective randomized control trial with a total of 142 patients. 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 Entereg as rescue therapy or to receive conservative standard care.
Patients randomized to the Entereg group will be given 12mg of Entereg two times daily from the time of randomization until the return of bowel function or 5 days. Both groups will be treated with conservative standard care, including bowel rest, reduction in oral diet, and placement of nasogastric tube as clinically indicated.
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.
Primary outcome will be hospital length of stay. Secondary outcomes will include time to return of bowel function, 30-day morbidity/mortality, complications, reoperation and readmission.
Total number of patients: 142 Patients in each study group: 71
详细描述
At the time of diagnosis of postoperative ileus and after enrollment and randomization, all patients will be returned to NPO status. Nasogastric tubes (NGT) may be placed for gastric decompression at the discretion of the surgical team if clinically indicated. In the event that an NGT is placed, medications will be given orally or via the NGT, which will be clamped for 30 minutes after administration. Patients will continue on standard ERAS pathways with the exception of reduction of diet. Antiemetics will be given as clinically indicated; however, no prokinetic or promotility agents will be given as scheduled dosages.
Patients randomized to the study group will be given 12mg of Entereg orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Patients randomized to the control group receive standard postoperative care.
The patient and surgical team will be able to know which arm of the study the patient is in based on documentation in the medical record of the administration of Entereg.
Patients in both groups will remain NPO until the return of bowel function, defined as passage of stool, decrease in nasogastric tube output. At this point, the nasogastric tube will be removed and a trial of oral diet will be attempted per surgeon's discretion.
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:
- •Return to NPO status after initial diet attempts, or
- •Placement of nasogastric tube
- •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 Entereg 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 were diagnosed with a complete small bowel obstruction preoperatively.
- •Subjects with a medical condition that may interfere with the use of the study medication Entereg.
- •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
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
干预措施: Alvimopan (Drug)
Control Group
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
干预措施: Control Group (Other)
结局指标
主要结局
Hospital Length of Stay
时间窗: up to 30 days
Date of surgery until discharge
次要结局
- Time to Return of Bowel Function(30 days)
- Complications(30 days)
- Number of Readmissions(30 days)
- Number of Reoperations(30 days)
研究者
Sharon Stein
Staff Surgeon, Associate Professor of Surgery
University Hospitals Cleveland Medical Center