NCT06232148

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

6 years

First QC Date

January 20, 2024

Last Update Submit

January 30, 2024

Conditions

Ventral Hernia

Keywords

cost

Outcome Measures

Primary Outcomes (1)

  • Mean procedural cost

    Total mean cost per procedure for all types of ventral hernias

    at the procedure

Secondary Outcomes (2)

  • Cost incisional

    at the procedure

  • Cost primary ventral

    at the procedure

Study Arms (3)

Robotic ventral hernia repairs

Device: Type of surgery

Open ventral hernia repairs

Laparoscopic ventral hernia repairs

Interventions

Type of surgeryDEVICE
Robotic ventral hernia repairs

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing ventral hernia repair in the inclusion period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. 2024 Feb;28(1):233-240. doi: 10.1007/s10029-023-02923-8. Epub 2023 Nov 30.

    PMID: 38036692BACKGROUND

  • 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.

    PMID: 37212128BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, MD, PhD, DmSci

Study Record Dates

First Submitted

January 20, 2024

First Posted

January 30, 2024

Study Start

January 1, 2017

Primary Completion

January 1, 2023

Study Completion

May 1, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share