A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI) in Subjects Undergoing Abdominal Operation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Time to achieve recovery of both upper and lower GI function as measured by a composite endpoint of time to the first bowel movement and time to tolerate first solid food. This endpoint is referred to as GI2.
研究概览
简要总结
This study is being conducted to determine whether Dexamethasone-Allantoin-Metronidazole (DAM) Solution can accelerate recovery of gastrointestinal function following abdominal operation when compared with a placebo.
详细描述
Postoperative ileus (POI) is temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. This functional impairment persists for a variable duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged POI, and increases the risk for related morbidity. This is a randomized, controlled, double-blind study designed to evaluate the tolerability and efficacy of DAM solution for the treatment of POI in patients following abdominal operation. It will be conducted at multiple centers in China. A total of 480 patients will be enrolled in the study. Patient participation in the study will last for up to postoperative day 7 [POD 7] , with follow-up safety assessments to occur 7 days after the operation.The treatment outcome measures include: 1) GI2(Time to achieve recovery of both upper and lower GI function as measured by a composite endpoint of time to the first bowel movement and time to tolerate first solid food). 2) Time to ready for discharge. 3) Time to the first flatus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are either Male or Female at least 18 years of age;
- •Had an American Society of Anesthesiologists (ASA) Physical Status Score of I-III;
- •Were scheduled to undergo partial small or large BR with primary anastomosis (performed completely by laparotomy); biliary-enteric Roux-en-Y anastomosis surgery;
- •BMI (kg/m^2) index≥15 and ≤30;
- •Understood the procedures, agreed to participate in the study program, and voluntarily signed the informed consent form.
排除标准
- •Had complete bowel obstruction;
- •Were scheduled for a total colectomy;
- •Were scheduled for a ileal pouch-anal anastomosis;
- •Were scheduled for a colostomy, ileostomy;
- •Had a history of gastrectomy, total colectomy, gastric bypass, short bowel syndrome, or multiple previous abdominal surgeries;
- •Had clinically significant laboratory abnormalities on screening(such as: ALT, AST were more than 2 times the upper limit of normal value; Cr is greater than 1.2 times the upper normal limit, according to the center for the study of the normal value range);
- •Applied the intravenous or epidural postoperative analgesia pump;
- •Bowel preparation does not meet the requirements;
- •Were allergy to components of the investigational drug (allantoin, metronidazole, dexamethasone);
- •Had used illicit drugs or had abused alcohol;
- •Had a history of illness, or behavior (e.g., depression, psychosis) that in the opinion of the investigator might confound the results of the study or pose an additional risk in participating in the study;
- •Women who were pregnant, and women who were of childbearing potential and not using method of birth control;
- •Had participated in another clinical drug trial within the last 3 months;
- •Were not agreed to participate the clinical trial by investigators.
研究组 & 干预措施
DAM Solution
Preheated to a temperature level, mixed the DAM Solution 2ml and Normal Saline 250ml, poured into abdominal cavity and infiltrate the operative field before the abdominal closure
干预措施: DAM (Drug)
Normal Saline
Preheated the Normal Saline 250ml to a temperature level, poured into abdominal cavity and infiltrate the operative field before the abdominal closure
干预措施: Normal Saline (Drug)
结局指标
主要结局
Time to achieve recovery of both upper and lower GI function as measured by a composite endpoint of time to the first bowel movement and time to tolerate first solid food. This endpoint is referred to as GI2.
时间窗: 7d
次要结局
- Time to ready for discharge(7 days)
- Time to the first flatus(7 days)
- Comparison between the 2 groups of analgesics (morphine) dose(7 days)
- peritoneal exudate volume of 72 hours after operation(3 days)
- C reactive protein changes from baseline(7 days)