Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Total number of days in the hospital
研究概览
简要总结
Ventral hernias are a common disease and one half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias may be associated with significant morbidity, including surgical site infection, hernia recurrence and reoperation. Minimally invasive ventral hernia repair decreases rates of surgical site infection and hospital length of stay, without affecting recurrence, however the laparoscopic approach to ventral hernia repair accounts for only about 1/3 of all total hernia repairs performed in the US. Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.
详细描述
Ventral hernias are a common disease and one-half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias are associated with substantial morbidity including surgical site infection, hernia recurrence, and reoperation. Randomized controlled trials and nationwide databases have shown that minimally invasive ventral hernia repair (i.e. laparoscopic ventral hernia repair) as opposed to open ventral hernia repair is associated with decreased rates of surgical site infection and hospital length of stay with no impact on long-term outcomes of hernia recurrence.
Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.
The growth of the robotic platform in surgery is growing exponentially. Despite this, the evidence supporting robotics remains limited. Studies demonstrating benefit such as improved outcomes or decreased hospital length of stay, are largely cohort studies subject to substantial bias. Among randomized controlled trials, none have demonstrated benefit with robotic surgery.
Recently, the America's Hernia Society (AHS) has endorsed robotic ventral hernia surgery. A series of studies published under the AHS Quality Collaborative (AHSQC) database have demonstrated improved outcomes with robotic ventral hernia repair when compared to open and laparoscopic surgery. However, the results of these studies remain hypothesis generating and randomized controlled trials are needed.
This study would represent among the first randomized controlled trials assessing the effect of robotic versus laparoscopic ventral hernia repair.
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
- Double (Participant, Outcomes Assessor)
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
- •All patients undergoing elective ventral hernia repair deemed appropriate for minimally invasive repair.
排除标准
- •Patients unlikely to survive beyond 2 years based upon surgeon judgment (e.g. advanced cirrhosis or metastatic cancer)
- •Patients unlikely to follow-up (e.g. lives out of state or no phone)
- •Advanced COPD or CHF
- •History of open abdomen or extensive lysis of adhesions for bowel obstruction
- •Ascites due to cirrhosis or malignancy
- •Active infection such as infected mesh
- •Ventral hernia size greater than 12 cm
结局指标
主要结局
Total number of days in the hospital
时间窗: 90 days post-operative
Total number of days spent in the hospital. This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery. This information will be collected up to 90 days after the surgery.
次要结局
- Surgical Site Infection (SSI)(post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years)
- Surgical Site Occurrence (SSO)(post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years)
- Hernia Reoccurence(post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years)
- Cost from a healthcare perspective(post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years)
- Patient centered outcomes(post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years)
研究者
Shinil Shah
Assistant Professor
The University of Texas Health Science Center, Houston