Mechanical Bowel Preparation for Elective Colorectal Anastomosis: Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Number of Participants with Surgical site infection
研究概览
简要总结
Colorectal surgery is highly associated with septic complications, therefore, multiple approaches have been used to reduce this complications, one of the most used is mechanical bowel preparation. Lately multiple studies have suggested that mechanical bowel preparation might not be necessary.
详细描述
Objective
Compare elective colorectal anastomosis with or without mechanical bowel preparation on outcomes, particularly anastomotic leak, surgical site infection, and ileum.
Materials and methods
A clinical trial was conducted including patients with colorectal pathology who underwent elective colorectal anastomosis. Patients were randomized into two groups; with mechanical bowel preparation (Group 1), and without mechanical bowel preparation (Group 2). Surgical, and non-surgical outcomes were evaluated, including anastomotic leak, surgical site infection, ileum, acute kidney injury, pneumonia, and mortality.
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages. Inferential analysis with student's t-test, and/or Mann-Whitney's U test; chi-square distribution, and/or Fisher's exact test respectively.
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
- None
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
- •Entitlement to the Mexican Institute of Social Security
- •Signed informed consent
- •Patients with colorectal pathology who needed primary elective colorectal anastomosis
- •Body mass index >18, and < 31
排除标准
- •Patients who dropped out from the study or withdrew the informed consent
- •Patients who did not accepted the surgical procedure
- •Patients who had been submitted to surgery before entering the protocol
- •Patients who need a colostomy
研究组 & 干预措施
Mechanical bowel preparation
80 Patients who received mechanical bowel preparation with 4 packets of polyethylene glycol in 4 liters of water, 4 hours before intervention.
干预措施: Polyethylene glycol (Drug)
结局指标
主要结局
Number of Participants with Surgical site infection
时间窗: 6 weeks
Following the surgical procedure, surgical site infection was evaluated if the patient presented specific signs and symptoms for this condition (redness, delayed healing, fever, pain, tenderness, warmth, or swelling), and confirmation with culture of the purulent discharge.
Number of Participants with Postoperative ileus
时间窗: 6 weeks
Following the surgical procedure, ileus was evaluated if the patient presented distended and tympanic abdomen, and absence or hypoactive bowel sounds, and confirmed with a plain abdominal radiography.
Number of Participants with Anastomotic leak
时间窗: 6 weeks
Following the surgical procedure, anastomotic leak was evaluated with fecal discharge on drainage and confirmed with computerized tomography.
次要结局
- Number of Participants with Abdominal sepsis(6 weeks)
- Number of Participants with Abscess(6 weeks)
- Number of Participants with Pneumonia(6 weeks)
- Number of Participants with Acute kidney injury(6 weeks)
- Number of Participants with Fistula(6 weeks)
研究者
CLOTILDE FUENTES OROZCO
PhD
Instituto Mexicano del Seguro Social