Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery : Phase II. Prospective, Randomised, Multicenter, Non-inferiority Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- The rate of surgical site infection
研究概览
简要总结
This is a prospective randomized study to evaluate the difference in the rate of surgical site infection between the patients who used Sodium Picosulfate solution(PicosolutionⓇ) and tablet Oral Sulphate Solution(ORA·FANGⓇ) for bowel preparation before colorectal cancer surgery .
详细描述
It has been reported that tablet oral sulphate solution(ORA·FANGⓇ) showed a successful bowel cleansing rate of 95.5%, which is similar to compared to sodium picosulfate solution(PicosolutionⓇ).
In terms of the rate of surgical site infection(SSI), sodium picosulfate solution(PicosolutionⓇ) showed 8% of SSI rate. However there is no report for the SSI rate of tablet oral sulphate solution(ORA·FANGⓇ). We aimed to compare the SSI rates between these two group.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are scheduled for an elective minimally invasive surgery for colorectal cancer
- •ASA score, 2 or less
排除标准
- •Bowel obstruction
- •FAP or IBD patients
- •Emergency operation
- •Breast feeding
- •Severe medical condition such as severe cardiac,hepatic, or renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),
- •Allergy to drug and refusal to participate in the study
研究组 & 干预措施
Oral Sulfate Tablet(ORA·FANGⓇ)
Subjects who are randomized into experimental arm will receive 14 pills at 8 pm in the evening 2days before the surgery and another 14 pills on 6am in the morning 1day before the surgery
干预措施: Oral Sulfate Tablet(ORA·FANGⓇ) (Drug)
Sodium Picosulfate Solution(PicosolutionⓇ)
Subjects who are randomized into experimental arm will receive 170ml of solution with at 8 pm in the evening 2days before the surgery and another 170ml of solution on 6am in the morning 1day before the surgery
干预措施: Sodium Picosulfate Solution(PicosolutionⓇ) (Drug)
结局指标
主要结局
The rate of surgical site infection
时间窗: 30 days
The operator will evaluate the rate of the surgical site infection during the postoperative hospitalization period or the first outpatient visit after surgery. We will use the definition of surgical site infection published in 1999 by the Centers for Disease Control and Prevention (CDC).
次要结局
- The quality of the bowel preparation(during surgery)
- The patient's tolerability for bowel preparation(1 day after bowel preparation)
研究者
Sung Sil Park
Clinical Professor
National Cancer Center, Korea