Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 604
- 试验地点
- 3
- 主要终点
- Comprehensive Complication Index
研究概览
简要总结
MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from 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
- Quadruple (Participant, 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
- •Patients scheduled for anterior rectal resection with primary anastomosis
排除标准
- •Emergency operation
- •Bowel obstruction
- •Existing stoma
- •Other reason preventing mechanical bowel preparation
- •Allergy to neomycin or metronidazole
- •Age < 18 years
- •Lack of co-operation
- •Exclusion criteria after randomization:
- •Patient did not undergo surgery
- •Anterior resection was not performed
- •Colonic anastomosis was not performed
研究组 & 干预措施
Mechanical Bowel Preparation and Oral Antibiotics
Mechanical Bowel Preparation and Oral Antibiotics
干预措施: Oral Antibiotics (Drug)
Mechanical Bowel Preparation and Oral Antibiotics
Mechanical Bowel Preparation and Oral Antibiotics
干预措施: Mechanical Bowel Preparation (Drug)
Mechanical Bowel Preparation Only
Mechanical Bowel Preparation Only
干预措施: Placebo (Drug)
Mechanical Bowel Preparation Only
Mechanical Bowel Preparation Only
干预措施: Mechanical Bowel Preparation (Drug)
结局指标
主要结局
Comprehensive Complication Index
时间窗: Within 30 days from surgery
Comprehensive Complication Index score
次要结局
- Surgical Site Infection(Within 30 days from surgery)
- Lenght of hospital stay(Within hospital stay, estimated on average 7 days)
- Mortality(Within 90 days from surgery)
- Adjuvant therapy(Within 6 months from surgery)
- Anastomotic dehiscence(Within 30 days from surgery)
研究者
Ville Sallinen
Adj. Prof.
Helsinki University Central Hospital