Risk Factors of Incisional Hernias After Emergency Midline Laparotomy: a Danish Prospective Single-center, Non-randomized, Non-interventional, Descriptive Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Risk factors of incisional hernia after emergency midline laparotomy
研究概览
简要总结
The aim of this study is to identify risk factors for the development of incisional hernias in emergency midline laparotomies.
详细描述
All patients operated with an emergency midline laparotomy and attending 1-year follow-up in our clinic is potential participants and will be screened for participation. Potential participants will be briefly informed about the project by the hospital staff. If the patients are interested, they will be thoroughly informed about the study and asked to participate by one of the trial investigators before discharge.
Data will be obtained from the participants hospital files and by patient survey/interview. All data will be entered into a database using RedCap by trial investigators or their delegates.
Enrolled patients will be followed for two years. The trial involves two clinical examinations and evaluations (one and two years) after surgery. Clinical examination involves interview with a standardized questionnaire and abdominal wall examination including inspection, palpation and ultrasound examination.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or above and
- •Unscheduled midline laparotomy in an emergency or subacute setting, involving perforated bowel, bowel obstruction, bowel ischemia (due to mesenteric vascular disease or incarceration), inflammatory diseases (e.g. diverticulitis, appendicitis, ulcerative colitis, cholecystitis and Crohn's disease), abscesses, non-traumatic intraabdominal bleeding and any emergency re-operation to elective surgery
排除标准
- •Age below 18 years
- •Patients with mental or physical disorders making follow-up impossible
- •Patients were no fascial closure is performed
结局指标
主要结局
Risk factors of incisional hernia after emergency midline laparotomy
时间窗: 2 years
Multivariate analysis on selected variables evaluated for long-term complications, including sex, age, high BMI, active smoking, hernia in the midline, length of incision, rectus muscle diastasis, sarcopenia, peritonitis and multiple laparotomies
次要结局
- 30-day, 90-day, 1-year and 2-year mortality(2 years)
- Rates of asymptomatic versus symptomatic incisional hernias(2 years)
- Rate of incisional hernias one and two years after surgery(2 years)
- Rate of surgery for incisional hernias 2-years post index surgery(2 years)
研究者
Madeline Kvist
Principal Investigator
Herlev Hospital