Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Surgery Related Complications
研究概览
简要总结
This study will help determine wether mechanical bowel preparation before a colostomy closure is necessary in pediatric population, in order to avoid surgery related complications (surgical site infection and anastomosis leakage).
Half of the population will go through the mechanical bowel prep before colostomy closure and the other half won´t. Complications rate will be compared among both groups.
详细描述
Mechanical bowel preparation is based on administering osmotic laxatives and enemas through the stomas, in order to diminish solid stool and bacterial load on the colon prior to a colostomy takedown. This was thought to decrease the surgery related complications.
However mechanical bowel preparation can cause discomfort in patients as well as other complications like hydro electrolyte imbalance.
Studies in adult population have shown that there is not a significant difference in the presence of surgery related complications in patients that received bowel prep and those who did not.
There is not enough evidence in pediatric patients that this affirmation is also true.
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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients who are to be submitted to a colostomy closure
排除标准
- •patients with more than 3 abdominal surgeries
- •patients with primary or acquired immunodeficiencies (including malnourishment)
- •Patients in which the distal intestine is closed in a Hartmann´s pouch
研究组 & 干预措施
Mechanical Bowel Preparation
Patients will receive enteric polyethylene glycol at 100 ml/kg/dose during 4 hours, and up to 3 times, prior to surgery.
Enemas with normal saline 20 ml/kg/do will be administered through the stomas 3 times a day
干预措施: Mechanical Bowel Preparation (Drug)
No Mechanical Bowel Preparation
Patients will not receive any preparation prior to surgery
干预措施: No Mechanical Bowel Preparation (Drug)
结局指标
主要结局
Surgery Related Complications
时间窗: up to 30 days
Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage
次要结局
未报告次要终点
研究者
Emilio Fernandez Portilla
Pediatric Colorectal Surgery Attending
Hospital Infantil de Mexico Federico Gomez