NCT04761536已完成不适用
Volume-outcome Relationship in Rectal Cancer Surgery
University of Rome Tor Vergata0 个研究点目标入组 187 人开始时间: 2006年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 主要终点
- Anastomotic leak
研究概览
简要总结
Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. However, no linear relation between volume and outcome has been demonstrated. Aim of the study was to evaluate the increased surgical volume effect on early outcomes of patient undergoing restorative anterior rectal resection (ARR).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •diagnosis of a cancer located in the rectum, defined according to the international definition by D'Souza et al.,
- •elective setting
- •anterior rectal resection with primary anastomosis (with or without diverting loop ileostomy).
排除标准
- •age below age of 18,
- •inflammatory bowel disease,
- •acquired or congenital immunodeficiency,
- •preoperative infection,
- •pregnancy,
- •presence of synchronous cancers,
- •abdominoperineal resection (APR),
- •failure to perform rectal resection and primary anastomosis,
- •emergency setting.
结局指标
主要结局
Anastomotic leak
时间窗: up to 30 days after discharge
rate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated
次要结局
- Ileus(up to 30 days after discharge)
- Bleeding(up to 30 days after discharge)
- Readmission(up to 90 days after discharge)
- 1-year stoma persistence(up to one year after surgery)
- Use of minimally invasive approach(up to 30 days after discharge)
- Surgical site infection(up to 30 days after discharge)
- Conversion to open surgery(up to 30 days after discharge)
- need of postoperative blood transfusion(up to 30 days after discharge)
- Postoperative complications(up to 30 days after discharge)
- Pneumonia(up to 30 days after discharge)
- Reoperation(up to 30 days after discharge)
- 30-days-mortality(up to 30 days after discharge)
- Length of hospital stay(up to 30 days after discharge)
- Operative time(up to 30 days after discharge)
研究者
Giuseppe Sigismondo Sica
MD, PhD, Associate Professor
University of Rome Tor Vergata
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