Phase 2 Study of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.
It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough.
The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.
详细描述
In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.
One randomized controlled study reported that surgical site infection rates of three doses prophylactic antibiotics are lower than those of one dose in colorectal surgery (4.3 versus 14.2%). But, surgical site infection rates between one dose and three doses were not different in laparoscopic subgroup of this study (11 versus 11%)
It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough.
The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have laparoscopic colorectal surgery for cancer at National Cancer Center
- •Patients should sign a written informed consent
- •Age between 18-80 years
- •Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
- •Adequate kidney function Creatinine ≤ 1.5 mg/dl
- •No remarkable evidence of heart dysfunction and lung dysfunction
排除标准
- •Patients undergo emergency surgery with multiple symptoms
- •Open colorectal surgery for cancer or conversion to an open procedure
- •Patients who undergo only ostomy surgery
- •Palliative surgery
- •Surgery combined with other organs
- •Patients on treatment with recurred cancer
- •Patients who have active bacterial infection and required parenteral antibiotics
- •Patients have an allergy to Cefoxitin
- •Other organ cancer history(except who had radical excision for skin cancer)
- •Presence of other serious disease
- •Mentally ill patients
- •Legally unable to participate in clinical trial
- •Lactating or pregnant women
- •Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
- •Not eligible to participate for other reasons by doctor's decision
研究组 & 干预措施
One dose
One dose prophylactic antibiotic
干预措施: Cefotetan (Drug)
结局指标
主要结局
Surgical site infection
时间窗: Three weeks after surgery
any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)
次要结局
- Overall infection(Three weeks after surgery)
研究者
Ji Won Park
M.D.
National Cancer Center, Korea