Economic Assessment of STarting Endoscopic Robotic Groin Hernia Repair

Inguinal Hernia Clinical Trial

— EASTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431271
• Other study ID #: EASTER study
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2020
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Robot-assisted hernia repair
Inguinal hernia repair was performed using the DaVinci Xi robotic system

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct costs	Material costs, hospitalization costs, specialist fees and costs related to early complications	Immediately post hospital discharge
Secondary	Indirect costs	Late complication costs, readmission costs	0- 42 days postoperatively