Early Closure of Temporary Ileostomy- a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Postsurgical morbidity
研究概览
简要总结
The study is being conducted as a prospective randomized controlled multicenter study of patients with a temporary ileostomy due to rectal cancer. The study will be conducted in hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes Group (www.ssorg.net).
The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead of later reversal more than 12 weeks after surgery.
详细描述
After creation of the temporary ileostomy patients are included and are randomized to two groups. Patients in the intervention group will have the stoma closed 8-13 days after stoma creation and will be compared to patients in the control group where the stoma is closed after a minimum of 12 weeks (standard treatment in Denmark and Sweden).
Before randomization the eligible patients undergo a CT of the rectum to visualise the anastomosis and possible leakage. Furthermore, the local investigators may choose to supplement the CT with a rectoscopy.
The research group includes 89 patients over an expected period of 4 years. Both groups are examined for postoperative complications as well as stoma-related complications at discharge and 3, 6 and 12 months after stoma creation.
The research group also examines the impact on patients´ health-related quality of life at 3, 6 and 12 months after stoma creation.
Finally the socio-economic effect in both groups will be analyzed and compared 6 and 12 months after stoma creation.
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
- 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
- •Patients with a temporary ileostomy after low anterior resection because of rectal cancer
- •Patients, who are physically and mentally fit to undergo surgery within 8-13 days
排除标准
- •Patients whose stoma is not reversible
- •Patients with diabetes
- •Patients being treated with Steroids
- •Patients with communicative problems
- •Patients with expected compliance issues
结局指标
主要结局
Postsurgical morbidity
时间窗: 6 months after inclusion
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Postsurgical morbidity.
时间窗: 12 months after inclusion-
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
次要结局
- Socio-economic effect of early reversal of temporary ileostomy(The investigators assess and analyze the economic effect 12 months after inclusion)
- Quality of life(Quality of life is assessed at 12 months after inclusion)
研究者
Anne Kjærgaard Danielsen
Research Nurse
Herlev Hospital