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临床试验/NCT07275346
NCT07275346
进行中(未招募)
不适用

Evaluating Surgical Approaches for Medium-to-Large Ventral Hernias: Open, Laparoscopic, and Robotic-Assisted Techniques

Andreas Älgå1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2018年1月1日最近更新:

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

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

发起方
Andreas Älgå
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Andreas Älgå

Principal Investigator

Karolinska Institutet

研究点 (1)

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