Study of Changes in Abdominal Fluid in Connection With Peritonitis. A Descriptive Study in Patients With Purulent or Fecal Peritonitis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- inflammatory response
研究概览
简要总结
Perforated diverticulitis of the colon can be complicated by peritonitis, either purulent or fecal. Both are life threatening conditions requiring emergency surgery. The background in terms of reasons for inflammation (diverticulitis) and perforation to develop is unknown. In this study we focus on specific changes associated with inflammation, both in tissues and of fecal and mucosal microbiota.
详细描述
A prospective study of abdominal fluid, periferal blood, tissues as well as feces in Patients (perforated diverticulitis with peritonitis undergoing emergency surgery, Group I), and in Controls (patients operated due to colorectal cancer, Group II; patients with mild diverticulitis not needing surgery, Group III).
Immune acitvity in abdominal fluid and periferal blood by immunoassay of 92 individual proteins. mRNA expression of 96 specific genes in tissue samples. Quatification of bacterial diversity in feces and colon mucosa.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs of perforated diverticulitis with peritonitis and decision to perform emergency surgery (Group I)
- •Signs of acute diverticulitis and no decision of emergency surgery (Group II)
- •Patients with colorectal cancer planned for elective surgery (Group III)
排除标准
- •No surgery performed (Group I and III)
- •Withdrawn consent (any group)
研究组 & 干预措施
Group I
Patients undergoing emergency surgery due to perforated diverticulitis with peritonitis.
No intervention, samples from abdominal fluid, blood, tissue, feces
Group II
Patients with colorectal cancer undergoing elective surgery. No intervention. Samples as for Group I
Group III
Patients with mild diverticulitis, not undergoing surgery. No intervention. Samples from blood and feces.
结局指标
主要结局
inflammatory response
时间窗: index surgery (Groups I and II)/ emergency room (Group III)
determination of levels of 92 proteins in abdominal fluid and blood
次要结局
- microbiota composition(index surgery (Groups I and II)/ emergency room (Group III))
- inflammatory response in tissue(index surgery (Groups I and II)/ emergency room (Group III))
研究者
Eva Haglind, MD, PhD, professor
professor
Sahlgrenska University Hospital