The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients: a Danish Prospective Single-center, Non-randomized, Non-interventional, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Early (30-days) MRI-diagnosed, incisional hernia development in high-risk patients after emergency midline laparotomy.
研究概览
简要总结
The aim of this study is to describe the development of symptomatic and asymptomatic incisional hernias after emergency midline laparotomy over time in high-risk patients evaluated by consecutive MRI-scans.
详细描述
All patients operated with an emergency midline laparotomy in our clinic are 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 four consecutive MRI-scans one month, three months, six months and two years after surgery. Change in quality of life, physical functioning and pain-score are also obtained by patient survey/interview at each visit. A concluding physical examination and abdominal wall ultrasound examination will be performed two years after the surgery.
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
- •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 or any emergency re-operation to elective surgery
- •Age of 18 years or above
- •BMI above 27
- •At least one risk factor for incisional hernia i.e. earlier midline laparotomy, BMI > 30, abdominal aortic aneurysm or prior surgery for abdominal aortic aneurysm, active smoking, liver cirrhosis, re-laparotomy, age > 75, history of primary ventral hernia (treated or untreated before index surgery), large laparotomy involving more than 2/3 of the abdominal wall as measured from the xiphoid process to the pubic bone
排除标准
- •Malign, incurable disease
- •Other reasons for short life expectancy <2 year as evaluated by the investigator
- •Midline-incisions <15 cm
- •Mesh augmentation of abdominal wall closure at index surgery or earlier mesh augmentation of the abdominal wall
- •Severe claustrophobia or any other mental habitus, making it impossible to perform MRI-scan without sedation
- •Metallic magnetic implants that serves as a contraindication for MRI-scan (including pacemakers, large tattoos, insulin pumps, etc.)
- •Metallic prosthetic non-magnetic implants that are suspected to create severe artefacts on the MRI-scan of the abdominal wall
结局指标
主要结局
Early (30-days) MRI-diagnosed, incisional hernia development in high-risk patients after emergency midline laparotomy.
时间窗: 2 years
次要结局
- MRI-diagnosed incisional hernia rates 3 months, 6 months and 2 years after laparotomy.(2 years)
- Change in quality of life, physical functioning, clinical investigation and pain-score at 1 month, 3 months, 6 months and 2 years after laparotomy.(2 years)
- 30-day, 90-day, and 1-year mortality.(1 year)
- Rate of MRI-verified subclinical vs. clinical detectable incisional hernias.(2 years)
研究者
Madeline Kvist
Principal Investigator
Herlev Hospital