Clinical Trials Directory

Trials / Completed

CompletedNCT04431271

Economic Assessment of STarting Endoscopic Robotic Groin Hernia Repair

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

Status
Completed
Phase
Study type
Observational
Enrollment
677 (actual)
Sponsor
Algemeen Ziekenhuis Maria Middelares · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDURERobot-assisted hernia repairInguinal hernia repair was performed using the DaVinci Xi robotic system

Timeline

Start date
2020-06-01
Primary completion
2020-07-31
Completion
2020-07-31
First posted
2020-06-16
Last updated
2020-08-27

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04431271. Inclusion in this directory is not an endorsement.