Conservative Treatment Versus Elective Repair of the Umbilical Hernia in Patients With Ascites and Liver Cirrhosis, a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- complications
研究概览
简要总结
The purpose of the present study is to investigate whether or not to perform elective surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are no other randomized controlled trials in this area. The optimal management in patients with umbilical hernias and liver cirrhosis with ascites is not clear yet. The general surgical opinion is that umbilical hernias in patients with ascites should not be corrected because of the supposedly high operative risks and high recurrence rates. Conservative treatment, however, can have severe complications resulting in emergency repair. Such operations carry a higher risk of complications than elective operations, particularly in this group of patients. Prospective and retrospective series showed us that elective hernia repair in this specific patient group is safe without major complications or high recurrence rates.
The aim of this study is to asses the optimal timing of correction of umbilical hernia in patients with liver cirrhosis and ascites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Primary Umbilical hernia
- •Liver cirrhosis
- •Ascites (US proven)
- •Age ≥ 18 years
- •Signed Informed consent
排除标准
- •Recurrent umbilical hernia
- •Midline laparotomy in medical history
- •ASA1 score IV or above
- •Incarcerated hernia related emergency procedures
- •Patent umbilical vein; >5mm
- •Expected time to Ltx <3 months
结局指标
主要结局
complications
时间窗: 2 years
The primary endpoint in this study is a composite endpoint of the overall morbidity after 24 months, which includes; Reoperation for complication (e.g. hemorrhage; Decompensated liver failure(e.g. Portal vein thrombosis; Non-closure of surgical wound at 4 weeks; Haematoma; Seroma; Rupture of hernia; Bowel incarceration; Necrosis and rupture of the overlying skin; Evisceration; Pneumonia; Urinal tract infection; Postoperative surgical site infection (superficial/deep/organ space); Postoperative leakage of ascites more than 2 weeks after surgery
次要结局
- Recurrence(2 years)
- Mortality(2 years)
- Length of hospital stay(3 months)
- Quality of life(2 years)
- Cost effectiveness(2 years)
研究者
hasan eker
Dr. G. Kazemier
Erasmus Medical Center