Prospective Randomized Controlled Trial to Reduce the Superficial Surgical Site Infection Due to a Contralateral Drainage Application in Loop Ileostomy Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application
研究概览
简要总结
- Introduction:
The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site infection (incidence 2-40%). There are various techniques related to closing loop ileostomy. In a retrospective study at our center, the investigators objectify that superficial surgical site infection rate was reduced by more than a half by the application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure. 2. Objectives and Hypothesis:
Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for rectal cancer) reduces the superficial surgical site infection.
Main objective: To reduce the rate of superficial surgical site infection by the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure. 3. Methodology:
Prospective and randomized clinical trial on the effectiveness of contralateral Penrose® drainage implementation in those patients that have a primary loop ileostomy (by low anterior rectum resection) closure to be able to know if the investigators can reduce the superficial surgical site infection rate. Monitorization until 30 days after surgery
详细描述
- Introduction:
The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site infection (incidence 2-40%). In the literature there are various techniques related to closing loop ileostomy that try to reduce the rate of infections recorded. In a retrospective study at our center, the investigators objectify that superficial surgical site infection rate was reduced by more than a half by the application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure. 2. Objectives and Hypothesis:
Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for rectal cancer) reduces the superficial surgical site infection.
Main objective: To reduce the rate of superficial surgical site infection by the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure.
Secondary objectives:
- Identify risk factors associated with superficial surgical site infection in relation to a primary loop ileostomy closure (with or without drainage).
- Reducing hospital stay and care at home.
- Methodology:
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient carrying loop ileostomy due to low anterior resection for rectal cancer.
- •Over 18 years.
- •Surgery scheduled.
- •Informed consent signed.
排除标准
- •Patients with terminal ileostomy.
- •Patients with loop ileostomy different from any surgery of rectal cancer.
- •To require another surgical procedure added.
- •Urgent surgery.
- •Patient refusal to participate in the study.
研究组 & 干预措施
Control Group
Patients with primary loop ileostomy closure without drainage of the surgical wound
Drainage Group
Patients with the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure.
Intervention: application of a contralateral drainage in surgical wound closure.
干预措施: application of a contralateral drainage (Penrose ® device) (Procedure)
结局指标
主要结局
Number of patients with surgical site infection after ileostomy closure depending if there is or not a penrose drainage application
时间窗: 30 days
次要结局
- Number of patients with seroma after ileostomy closure surgery(30 days)
- Number of patients with anastomotic leak after ileostomy colsure surgery(30 days)
- Number of patients with hematoma after ileostomy closure surgery(30 days)
研究者
Xavier Serra-Aracil
Medical Doctor
Corporacion Parc Tauli