Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Primary endpoint is to compare peritonitis related complications and Comprehensive Complication Index (CCI) between NPWT treatment (VAC) and conventional treatment (ROD) at 30, 90 days and 1 year.
研究概览
简要总结
Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy "on-demand".
详细描述
Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis* to either vacuum assisted closure or relaparotomy "on-demand". The aim with our study is to compare the postoperative complications between vacuum assisted closure and relaparotomy "on-demand".
Primary endpoint is to compare peritonitis related complications and Comprehensive Complication Index (CCI) between NPWT treatment (VAC) and conventional treatment (ROD) at 30, 90 days and 1 year.
Secondary outcome parameters are: Mortality at 30, 90 days and 1 year, SOFA score and C-reactive protein measured the first seven days after index laparatomy, quality of life after 3 and 12 months (SF-36 questionnaire), ventral hernia after 3 and 12 months. (assessed by CT) and, hospital care utility within three months after index surgery. A power calculation was made which concluded that 340 patients should be included.
*Diffuse fecal peritonitis is defined as contamination of 2 out of the 4 abdominal quadrants with fecal contamination starting from the small intestine, colon or rectum.
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients eligible for enrolment are 18+ years of age and are scheduled for acute laparotomy due to suspected peritonitis originating from perforation of the small bowel, colon, or rectum. To be included, purulent, enteric, or fecal contamination in a minimum of 2 out of 4 quadrants must be confirmed.
排除标准
- •Diffuse peritonitis originating from a different focus than the small intestine, colon or rectum
- •Diffuse peritonitis originating from a perforation on the stomach, duodenum, gallbladder, appendix, necrotizing pancreatitis, salpingitis, or peritoneal dialysis
- •Primary peritonitis
- •Immunocompromised (ongoing chemotherapy or prednisolone >20 mg/day)
- •Chronic parenchymal liver disease
- •Pregnancy
- •Patients with end-stage disease
- •Laparoscopic surgery (not converted to laparotomy)
- •Acute occlusion of superior mesenteric artery
- •Peritoneal carcinomatosis
- •Abdominal trauma
- •Lack of consent from the surgical equipoise
- •Local peritonitis confined to 1 quadrant only
结局指标
主要结局
Primary endpoint is to compare peritonitis related complications and Comprehensive Complication Index (CCI) between NPWT treatment (VAC) and conventional treatment (ROD) at 30, 90 days and 1 year.
时间窗: 1 year
Disease-Related Major Morbidity Needing Readmission and Conservative Treatment but Not Surgery * Fistula * Wound dehiscence/incisional hernia with obstruction * Abscess needing percutaneous drainage * Renal failure * Myocardial infarction * Gastric or duodenal bleeding * Respiratory failure * Urosepsis Disease-Related Major Morbidity Needing Surgical Intervention During First Admission or Readmission * Incisional hernia * Bowel obstruction or herniation due to intra-abdominal adhesions * Burst abdomen * Abdominal compartment syndrome * Fistula * Intra-abdominal bleeding * Intra-abdominal hematoma needing surgical evacuation * Perforation of visceral organ confirmed at surgery * Anastomotic leakage * Ischemia or necrosis of a visceral organ * Enterostomy dysfunction due to prolapse, stenosis, or retraction * Gastric or duodenal ulcer bleeding needing intervention of any type
次要结局
- Quality of life after treatment(3 and 12 months)
- Ventral hernia rate(3 and 12 months)
- Mortality at 30, 90 days and 1 year(1 year)
- Hospital care utility within three months after index surgery(Up to 12 weeks)
研究者
Pooya Rajabaleyan
Principal investigator
Odense University Hospital