Cost Evaluation of Robotic Ventral Hernia Repair

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06232148
• Other study ID #: robotic hernia repair
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: May 1, 2023

Study information

• Verified date: January 2024
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: May 1, 2023
• Est. primary completion date: January 1, 2023
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Exclusion Criteria: none

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Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• Type of surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

References & Publications (2)

Henriksen NA, Helgstrand F, Jensen KK. Short-term outcomes after open versus robot-assisted repair of ventral hernias: a nationwide database study. Hernia. 2023 Nov 30. doi: 10.1007/s10029-023-02923-8. Online ahead of print. — View Citation

Jensen KK, Helgstrand F, Henriksen NA. Short-term Outcomes After Laparoscopic IPOM Versus Robot-assisted Retromuscular Repair of Small to Medium Ventral Hernias: A Nationwide Database Study. Ann Surg. 2024 Jan 1;279(1):154-159. doi: 10.1097/SLA.0000000000005915. Epub 2023 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean procedural cost	Total mean cost per procedure for all types of ventral hernias	at the procedure
Secondary	Cost incisional	Total mean cost per procedure for incisional ventral hernias	at the procedure
Secondary	Cost primary ventral	Total mean cost per procedure for primary ventral hernias	at the procedure