Ventral HerniaNCT06232148
Cost Evaluation of Robotic Ventral Hernia Repair
An observational study of Ventral Hernia, run by Bispebjerg Hospital.
Trial summary
To evaluate the procedural cost of robotic ventral hernia repair compared with open ventral hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Type of surgery
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 May 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: All patients undergoing ventral hernia repair in the inclusion period
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- Type of surgery
- Keywords
- cost
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of surgeryDevice
| Study group | Role | What they receive |
|---|---|---|
| Robotic ventral hernia repairs | Not described Receives: Device: Type of surgery | |
| Open ventral hernia repairs | Not described | |
| Laparoscopic ventral hernia repairs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean procedural cost
Total mean cost per procedure for all types of ventral hernias
Measured: at the procedure
Secondary outcomes (2)
Cost incisional
Total mean cost per procedure for incisional ventral hernias
Measured: at the procedure
Cost primary ventral
Total mean cost per procedure for primary ventral hernias
Measured: at the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jan 2017
- Primary completion1 Jan 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Kiim Jensen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232148
- Sponsor's protocol ID
- robotic hernia repair
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38036692Jensen 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.
PubMed 37212128
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Cost Analyses of Robotic Ventral Hernia Repair Compared With Laparoscopic or Open Repair: A Cohort Study
- ClinicalTrials.gov ID
- NCT06232148
- Acronym / sponsor ID
- robotic hernia repair
- Conditions
- Ventral Hernia
- Keywords
- cost
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the procedural cost of robotic ventral hernia repair compared with open ventral hernia repair.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robotic ventral hernia repairs | – | Device: Type of surgery |
| Open ventral hernia repairs | – | – |
| Laparoscopic ventral hernia repairs | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing ventral hernia repair in the inclusion period
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of surgery | Device | Robotic ventral hernia repairs |
Primary outcome
Mean procedural cost
Time frame: at the procedure
Total mean cost per procedure for all types of ventral hernias
2 secondary outcomes
Cost incisional
Time frame: at the procedure
Cost primary ventral
Time frame: at the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 38036692Henriksen 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.
- Background: PubMed 37212128Jensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia, run by Bispebjerg Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean procedural cost (time frame: at the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06232148, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.