跳至主要内容
临床试验/NCT04431271
NCT04431271已完成不适用

Retrospective Comparative Study on Costs of Conventional Versus Robotic Assisted Laparoscopic Groin Hernia Repair

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 677 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
677
试验地点
1
主要终点
Direct costs

研究概览

简要总结

The material cost for robotic groin hernia repair is higher than for conventional laparoscopic surgery. In this study, this amount will be quantified and possible differences in early postoperative course, hospital stay and readmission rate that could influence the cost/benefit ratio for robotic groin hernia surgery will be analyzed.

详细描述

Robot-assisted groin hernia repair has been introduced in AZ Maria Middelares hospital since September 2016. In these procedures, the daVinci robot is being used to perform minimal invasive repair of these hernias. At the moment, this technique is frequently being used for groin hernia repair. Literature shows a clear benefit of robot-assisted versus open repair. Hospital stay decreases and complications are less frequently observed in patients who underwent minimal invasive repair (Henriksen NA et al., 2018).

On the other hand, the benefits of robot-assisted repair are less obvious compared to conventional laparoscopy. Many robot-trained surgeons are in favor of robot-assisted repair, but current literature is still inconclusive about the economic feasibility of robot-assisted groin hernia repair as standard of care.

This retrospective observational study is primarily designed to analyze the additional cost of robot-assisted groin hernia repair compared to conventional laparoscopic repair. A cost-benefit analysis will be carried out for groin hernia repairs performed by the same surgeon (Dr. Filip Muysoms) in the period 2016-2019.

As primary endpoint, direct costs related to the introduction of robot-assisted groin hernia repair will be analyzed. These are: material costs, costs related to hospital stay, honoraria and costs related to intrahospital complications. A comparison will be made between conventional laparoscopic and robot-assisted groin hernia repair.

As secondary endpoint, indirect costs will be compared between both groups. These include costs related to late complications and readmissions related to the index operation.

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

  • adult patients
  • underwent uni-or bilateral groin hernia repair in the period 2015- 2019
  • surgery through minimal invasive repair

排除标准

  • open surgery or conversion from minimal-invasive to open surgery
  • combined procedures
  • age below 18 years

结局指标

主要结局

Direct costs

时间窗: Immediately post hospital discharge

Material costs, hospitalization costs, specialist fees and costs related to early complications

次要结局

  • Indirect costs(0- 42 days postoperatively)

研究者

发起方
Algemeen Ziekenhuis Maria Middelares
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filip Muysoms

Principal Investigator

Algemeen Ziekenhuis Maria Middelares

研究点 (1)

Loading locations...

相似试验