Evaluating Surgical Approaches for Medium-to-Large Ventral Hernias: Open, Laparoscopic, and Robotic-Assisted Techniques
概览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- Andreas Älgå
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- % of patients with Textbook Outcome
概览
简要总结
The purpose of this project is to investigate whether the use of the new robot-assisted technique in surgery for large and medium-sized ventral midline hernias has brought tangible benefits to patients in terms of Textbook outcome, length of stay, complications and recurrence, compared to open technique and conventional laparoscopic technique. In addition, the investigators will assess the health economic aspects of the different techniques.
详细描述
In the Stockholm Region, ventral hernia surgeries are performed at Södersjukhuset, Danderyds Hospital, Södertälje Hospital, Norrtälje Hospital, St Göran Hospital, Ersta Hospital and Karolinska Hospital. The hospitals differ in terms of admission areas, profile areas and access to surgical robots for hernia surgery. Since the introduction of robot-assisted surgery in Stockholm around 2017-2018, Södersjukhuset and Danderyd Hospital have used this technology to varying extents for ventral hernia, while the other hospitals have only offered open and conventional laparoscopic surgery. There is no established distribution of hernia patients in the region and no joint treatment conferences. The patients have therefore been distributed primarily depending on place of residence and referral patterns between the hospitals, which has also influenced the choice of method. Similar hernia patients have thus been offered different surgical treatments depending on which hospital in Stockholm the patient was treated at.
The robotic platform involves significant investment costs and costs for robotic instruments. Several studies also indicate that the surgical time is often longer, which can also increase costs. However, the promising results with shorter hospital stay and fewer complications could outweigh the increased surgical costs that have been demonstrated in several studies. The investigators will compare the costs of robot-assisted ventral hernia surgery in the operating room, in the hospital and after discharge with the corresponding costs for open and conventional laparoscopic surgery. Cost-effectiveness analyses will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Large and medium-sized midline hernias (EHS classification W2-W3)
排除标准
- •Hernia operations combined with bowel procedures
结局指标
主要结局
% of patients with Textbook Outcome
时间窗: 1 month post surgery
Textbook Outcome is a composite outcome that will be used as a measure of a problem-free postoperative recovery. Textbook Oitcome will be defined as the absence of complications, prolonged hospital stay, readmission, and reoperation. Textbook Outcome is a binary outcome measure; the patient will either have Textbook Outcome (i.e. a problem-free postoperative recovery) or not (i.e. not a problem-free postoperative recovery).
次要结局
- Rate of.post operative complications(1 month post surgery)
- Recurrence(2-7 years post surgery)
- Length of stay(Perioperatively)
- Cost(Up to 1 year post surgery)
研究者
Andreas Älgå
Principal Investigator
Karolinska Institutet