Cost Evaluation of Robotic Ventral Hernia Repair

January 30, 2024 updated by: Kristian Kiim Jensen, Bispebjerg Hospital

Procedural Cost Analyses of Robotic Ventral Hernia Repair Compared With Laparoscopic or Open Repair: A Cohort Study

To evaluate the procedural cost of robotic ventral hernia repair compared with open ventral hernia repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ventral hernia repair is one of the most frequently performed elective surgeries worldwide. The surgical approaches vary depending on the patient characteristics, type, and location the of ventral hernia, as well as the surgeons' preferences and equipment availability.

The choice between an open or minimally invasive approach has been debated for years, and it seems clear that the risk of wound infection is significantly decreased when choosing a minimally invasive approach, whereas there are no significant difference in recurrence rates. In the past decades, the use of a robotic system for ventral hernia repair has gained increasing popularity due to an easy access to the preperitoneal or retromuscular plane with a minimally invasive technique.

Two nationwide cohort studies concluded that length of stay and postoperative morbidity was decreased for robot-assisted repairs compared to open or laparoscopic ventral hernia repairs. Critics of robot-assisted surgery argue that it is time-consuming, too expensive, and that further cost-effectiveness analyses are needed to weigh the clinical benefits.

The aim of these studies was to compare the procedure-specific cost of robot-assisted with open primary ventral and incisional hernia repair and thereafter with laparoscopic repairs.

Study Type

Observational

Enrollment (Actual)

3000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing ventral hernia repair in the inclusion period

Description

Inclusion Criteria: patients undergoing elective primary ventral and incisional hernia repair -

Exclusion Criteria: none

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Robotic ventral hernia repairs
Device: Type of surgery
Open ventral hernia repairs
Laparoscopic ventral hernia repairs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean procedural cost
Time Frame: at the procedure
Total mean cost per procedure for all types of ventral hernias
at the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost primary ventral
Time Frame: at the procedure
Total mean cost per procedure for primary ventral hernias
at the procedure
Cost incisional
Time Frame: at the procedure
Total mean cost per procedure for incisional ventral hernias
at the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

January 20, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • robotic hernia repair

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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