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OpenTrials
Completed

NCT Number: NCT04431271

Economic Assessment of STarting Endoscopic Robotic Groin Hernia Repair

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Robot-assisted hernia repair

Procedure

Inguinal hernia repair was performed using the DaVinci Xi robotic system

Primary outcomes

  1. Direct costs

    Time frame: Immediately post hospital discharge

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

Secondary outcomes

  1. Indirect costs

    Time frame: 0- 42 days postoperatively

    Late complication costs, readmission costs

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

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

Acronym: EASTER

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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