Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of patients with 30 day mortality
研究概览
简要总结
P) patients with acute obstructive colon cancer I) resection or bridge to surgery with stent or stoma C) emergency procedure O ) morbidity and mortality within 30 days, 90 day mortality and 3 & 5 years overall survival
详细描述
The aim of this prospective observational study is to evaluate primary resection for malignant obstruction of the colon compared to only decompression as first intervention regarding postoperative outcomes. We hypothesize that patients with malignant obstruction benefit from avoidance of emergency cancer resection, by a two-stage procedure, with decompression by a stoma or stent as first intervention, leading to decreased short-term morbidity and mortality and improved long-term oncological outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Symptomatic large bowel obstruction requiring acute intervention
- •CT-verified colon obstruction due to colon cancer independent of presence of metastases
- •Informed consent
排除标准
- •Colonic perforation or bleeding
- •Colonic obstruction of other origin than colon cancer
- •Palliative situation
结局指标
主要结局
Number of patients with 30 day mortality
时间窗: 30 days
death within 30 days
Overall survival after 5 years
时间窗: 5 years
survival unspecified
Number of patients with 90 day mortality
时间窗: 90 days
death within 90 days
Number of patients with 30-day severe morbidity
时间窗: 30 days
Clavien-Dindo \>3 within 30 days postop
Overall survival after 3 years
时间窗: 3 years
survival unspecified
次要结局
- Proportion of patients receiving neoadjuvant or adjuvant treatment(1 year)
- Morbidity and survival and impact of tumour location(5 years)
- Proportion of patients not being subjected to resection of initially decompressed(90 days)
- Number of examined mesenteric lymph nodes(90 days)
- Number of stoma complications(90 days)
- Number of laparoscopic resections(90 days)
- bridging interval(90 days)
- total hospital stay in days(90 days)
- Number of patients with locally radical resections(90 days)
- Proportion of patients with stomas after 3 years(3 years)
- Recurrence rate after 3 after years(3 years)
- Disease-free survival after 3 years(3 years)
- Number of stent complications (perforations, migration, bleeding, success rate etc)(90 days)
- Number of primary anastomosis(90 days)
- colorectal surgeon performing resectional surgery(90 days)
- Number of stomas after resection and type of stoma(90 days)
研究者
Pamela Buchwald
consultant colorectal surgeon, associate professor
Skane University Hospital