Economic Assessment of STarting Endoscopic Robotic Groin Hernia Repair (EASTER)

Retrospective Comparative Study on Costs of Conventional Versus Robotic Assisted Laparoscopic 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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Robot-assisted hernia repair

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.

• Study Type: Observational
• Enrollment (Actual): 677

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • AZ Maria Middelares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who underwent uni-or bilateral groin hernia repair in the period 2015- 2019. Only patients who underwent minimal-invasive surgery (conventional or robot-assisted laparoscopy) will be included.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robot-assisted laparoscopy; Patients who underwent robot-assisted groin hernia repair	Procedure: Robot-assisted hernia repair; Inguinal hernia repair was performed using the DaVinci Xi robotic system
Conventional laparoscopy; Patients who underwent conventional laparoscopic groin hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct costs	Material costs, hospitalization costs, specialist fees and costs related to early complications	Immediately post hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indirect costs	Late complication costs, readmission costs	0- 42 days postoperatively

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Filip Muysoms, MD, PhD, Algemeen Ziekenhuis Maria Middelares

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: EASTER study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No