A Prospective, Randomized, Blind, Multicenter Trial Comparing Orally Administered Trimethoprim-sulfamethoxazole With Intravenously Administered Cefuroxime and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,073
- 试验地点
- 6
- 主要终点
- Cutaneous-,subcutaneous and intraabdominal infections
研究概览
简要总结
The current standard Swedish infection prophylaxis in colorectal surgery is intravenously administered cefuroxime and metronidazole. this combination is well studied. The disadvantages of the regimen is "collateral damage" resulting from treatment with a cephalosporine and that the combination also serves as the first line of treatment for abdominal surgical infections.
Serval Swedish surgical departments have for some years used a combination of orally administered trimethoprim-sulfamethoxazole and metronidazole.
The combination is economical and believed to be effective but hitherto the outcome have not been properly researched.
The aim of this study is to compare the efficacy of these two regimens in the prevention of infection after elective colorectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Age >= 18 years
- •Planned clean/clean-contaminated colorectal resection will be performed
- •Understand spoken and written swedish language
排除标准
- •Hypersensibility to the test or control drug
- •Severe liver failure
- •Blood dyscrasia
- •Ileus or gastric retention
- •Current visceral perforation
- •Current treatment with antibiotics
- •Current treatment with steroids
- •Cytotoxic or radiation therapy within 4 weeks of the planned operation
- •Active IBD (inflammatory bowel disease)
- •Incapability to swallow tablets
- •Other study interfering with this study
- •Current pregnancy
- •Bad regulated diabetes
- •Current enterocutaneous or colocutaneous fistula
研究组 & 干预措施
ordinary per operative prophylaxis
cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia
干预措施: cefuroxime and metronidazole (Drug)
Per oral alternative
Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation
干预措施: trimethoprim-sulfamethoxazole + metronidazole (Drug)
结局指标
主要结局
Cutaneous-,subcutaneous and intraabdominal infections
时间窗: 4 weeks
次要结局
- Septicaemia(4 weeks)
- Non infectious wound complications(4 weeks)
- Other post operative infections(During hospital stay)
- Complications to the anastomosis(4 weeks)
- Adverse reaction of given drug(4 weeks)
研究者
Claes Hjalmarsson
MDPhD
Halmstad County Hospital