Economic Assessment of STarting Endoscopic Robotic Groin Hernia Repair

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Robot-assisted hernia repair

• Registration Number: NCT04431271
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

Brief 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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 677

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robot-assisted laparoscopy	Robot-assisted hernia repair	Patients who underwent robot-assisted groin hernia repair

Primary Outcome Measures

Name	Time	Method
Direct costs	Immediately post hospital discharge	Material costs, hospitalization costs, specialist fees and costs related to early complications

Secondary Outcome Measures

Name	Time	Method
Indirect costs	0- 42 days postoperatively	Late complication costs, readmission costs

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Gent, Oost-Vlaanderen, Belgium