Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 8
- 主要终点
- Overall post-operative complication rate defined according to the Clavien-Dindo Classification
研究概览
简要总结
The purpose of this multi-center randomized trial is to identify any differences in the complication rates of patients undergoing Hartmann's (end colostomy) versus Primary Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including the stoma reversal operation).
详细描述
Hartmann's operation: the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy.
End colostomy: A stoma is created from one end of the bowel while the other portion of the bowel is either removed or sewn shut (Hartmann's pouch).
The second operation (reversal) requires a colo-rectal anastomosis.
Primary anastomosis: colonic resection with primary anastomosis and defunctioning ileostomy. The second operation (stoma reversal) requires an entero-enteral anastomosis.
Anastomosis: is to join together two bowel ends to restore continuity after resection or stoma formation.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age > 18 years
- •Left-sided colon perforation
- •German language speakers
排除标准
- •Patient age < 18 years
- •Perforation outside of the left-colon
- •Bowel obstruction/disease without perforation
- •Evidence of metastasis
结局指标
主要结局
Overall post-operative complication rate defined according to the Clavien-Dindo Classification
时间窗: 2006 - 2010
The Clavien-Dindo Classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Requiring pharmacological treatment with drugs. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU-management. Grade V: Death of a patient
次要结局
- Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the primary operation(2006 - 2010)
- Serious post-operative complication rate (Clavien-Dindo grade ≥III) for the reversal operation(2006 - 2010)
- Overall total number of complications(2006 - 2010)
- Number of complications for the primary operation(2006 - 2010)
- Number of complications for the reversal operation(2006 - 2010)
- Reversal rate(2006 - 2010)
- Operation time(2006 - 2010)
- Length of Intensive Care Unit (ICU) stay(2006 - 2010)
- Length of hospital stay(2006 - 2010)
- In-hospital costs(2006 - 2010)