oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias - the PRIOR Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Primary outcome: length of stay
研究概览
简要总结
This study investigates on the effect of two different operative techniques to treat large abdominal wall defects.
The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR).
The main questions it aims to answer are:
length of stay after the operation rate of complications rate of recurrence and reoperations quality of life.
Participants will:
Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.
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 are blinded to their treatment allocation until hospital discharge criteria according to the primary endpoint are fulfilled. After discharge, blinding is difficult to be ensured because there is no control, if dressing have been removed or modified. To ensure patient blinding during hospital stay, patients from both treatment arms will receive identical dressings as if an open and minimal-invasive access had been performed. In case the dressing must be changed during the hospital stay, this will be performed while the patient is blinded using a cover.
In case for any reason the patient has been unblinded to his treatment allocation (accidental or intentional dressing removal, bed-side wound opening, other) all outcome data are assessed regardless and unblinding is documented and reported in the final report.
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
- •Patient age >18 years
- •Informed consent obtained
- •Transverse diameter of ventral hernia >4cm - 15cm
- •Eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment
排除标准
- •precedent hernia treatment with mesh placement in the retromuscular space
- •precedent anterior or posterior component separation or transversus abdominis release (TAR)
- •active wound infection
- •current cancer diagnosis
- •presence of ileostomy, colostomy or ileal conduit
- •liver disease defined by the presence of ascites
- •end-stage renal disease requiring dialysis
- •need of an emergency surgery
- •pregnancy
- •Criteria for participating surgeons Each participating surgeon has performed 20 or more OVHR and RVHR.
研究组 & 干预措施
Open ventral hernia repair (OVHR)
干预措施: Open ventral hernia repair (OVHR) (Procedure)
Robotically-assisted ventral hernia repair (RVHR)
干预措施: Robotically-assisted ventral hernia repair (RVHR) (Procedure)
结局指标
主要结局
Primary outcome: length of stay
时间窗: 30 days
Length of stay Length of stay is defined as the time from the operation until patient discharge is feasible according to the following criteria: * pain on numeric rating scale (NRS) \< 4 without opioid use * tolerance of oral food intake without nausea / vomiting * no signs of surgical site occurrence (SSO) or other postoperative complications * no drains in place * autonomy in daily living activities
次要结局
- Adverse events(30 days)
- Comprehensive complication index (CCI)(30 days)
- Functional recovery(5 years)
- Quality of life using SF-12 form(5 years)
- pain after surgery(5 years)