Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Length of Stay
研究概览
简要总结
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.
详细描述
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair. This is a superiority trial with a primary outcome of length of stay in the hospital, theorizing that robotic retromuscular ventral hernia repairs are superior to open ventral hernia repairs by reducing length of stay by 24 hours. Patients will be blinded to the intervention, groups will be in parallel, and the primary outcome (when the patient is discharged) will be determined by a blinded assessor.
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)
盲法说明
Patients will be blinded to the intervention. The primary outcome will be determined by a surgeon other than the operating surgeon who is blinded to the intervention. Patients will also receive the same dressings over their wounds and an abdominal binder will be placed over the abdomen in attempts to limit the unblinding of the patient.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years and older
- •7 cm to 15 cm wide hernia midline defects
- •BMI less than or equal to 45
- •Patient deemed both an open and robotic candidate by operating surgeon
排除标准
- •17 years old or younger
- •prisoners
- •pregnant patients
- •Emergent patients
- •BMI greater than 45
- •Hernia defects less than 7 cm or greater than 15 cm in width
研究组 & 干预措施
Open Ventral Hernia Repair
These patients will undergo open retromuscular ventral hernia repairs
干预措施: Ventral Hernia Repair (Procedure)
Robotic Ventral Hernia Repair
These patients will undergo robotic retromuscular ventral hernia repairs.
干预措施: Ventral Hernia Repair (Procedure)
结局指标
主要结局
Length of Stay
时间窗: 30 days
Time in the hospital after the surgery
次要结局
- Opioid consumption(30 days and one year)
- Post-operative wound complications(30 day and one year)
- Readmission rate(30 days)
- Acute pain scores(5 days after surgery)
- Hernia recurrence(30 days and one year)
- Quality of life scores using European Hernia Society (EuraHS) scale(30 day and one year)
- Other post operative complications(30 days)
- Direct cost(30 days)
- Hernia Related Specific Quality of Life Score(30 days and one year)
研究者
Lucas Beffa
Assistant Professor of Surgery
The Cleveland Clinic