Does Icodextrin Reduce the Risk of Small Bowel Obstruction?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,808
- 试验地点
- 13
- 主要终点
- Surgery for small bowel obstruction
研究概览
简要总结
The study aims at investigating if icodextrin 4% instilled in abdominal cavity during surgery can reduce the risk of surgery and hospitalisation for small bowel obstruction in patients with colorectal cancer. Follow-up data is collected from the Swedish national colorectal cancer registry.Patients are followed for 5 years postoperatively.The study is a randomized Swedish multicenter study and planned to include 1,800 patients. A safety control is planned after 300 included patients.
详细描述
Icodextrin 7.5% is used in peritoneal dialysis. In animal models and in gynecological surgery a 4% solution of Icodextrin has been tested as a possible agent of reducing adhesions by acting as a barrier between peritoneal surfaces. Some data support a reduction af adhesions (van den Tool et al., Brown et al.). However, is not known whether icodextrin reduces the need for surgery or hospitalisation for small bowel obstruction.This study aims to study these parameters as well as complications and survival.
Patients with colorectal cancer and scheduled for surgery with curative intent will be (after patients acceptance) randomized to have icodextrin 4% instilled in the abdominal cavity or not. Patients allocated to icodextrin arm will have 100 ml of icodextrin 4% instilled every 30 minutes during surgery and at end of operation further 1000 ml instilled in the abdominal cavity. Postoperative care is performed according to each hospital praxis.
Follow-up data will be collected from the Swedish National Colorectal cancer registry. Data 30 days postoperatively will be analysed for early small bowel obstruction and other early complications. The study ends 5 years postoperatively with analysis of surgery and hospitalization for small bowel obstruction as well as survival and longterm complications.
A safety analysis is planned after the first 300 randomized patients with respect to early (30 days) complications. These data will analysed blindly by external reviewers.
Randomization (1:1) will be performed at the Regional Cancer Centrum in the Uppsala-Örebro region. The study aims to randomise 1800 patients.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal cancer
- •Curative surgery planned
- •Informed consent
- •Age 18-85
排除标准
- •Local surgery planned
- •Generalized disease
- •Other malignancy
- •Not informed consent
研究组 & 干预措施
Surgery and Icodextrin
Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen
干预措施: Surgery (Procedure)
Surgery and Icodextrin
Icodextrin 4% instilled every 30 minutes during surgery and 1000 ml instilled before closure of abdomen
干预措施: Icodextrin (Drug)
Surgery
No instillations during surgery
干预措施: Surgery (Procedure)
结局指标
主要结局
Surgery for small bowel obstruction
时间窗: 5 years
The proportion of patients that have undergone surgery for small bowel obstruction will be compared between the groups.
次要结局
- Postoperative complications(30 days)
- Hospitalisation for small bowel obstruction(5 years)
- Overall and cancer survival(5 years)