Ventral HerniaNCT07275346
Surgical Approaches for Medium-to-Large Ventral Hernias: Open, Laparoscopic, and Robotic-Assisted Techniques
An observational study of Ventral Hernia, run by Andreas Älgå at 1 site in Sweden.
Trial summary
The purpose of this project is to investigate whether the use of the new robot-assisted technique in surgery for large and medium-sized ventral midline hernias has brought tangible benefits to patients in terms of Textbook outcome, length of stay, complications and recurrence, compared to open technique and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- How many people
- 750 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients registered in the Swedish Abdominal Hernia Registry and operated on at Södersjukhuset, Ersta Hospital, Danderyd Hospital, or Södertälje Hospital
Who may be able to join
- Large and medium-sized midline hernias (EHS classification W2-W3)
Who cannot join
- Hernia operations combined with bowel procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Surgical Approaches for Medium-to-Large Ventral Hernias: Open, Laparoscopic, and Robotic-Assisted Techniques
The purpose of this project is to investigate whether the use of the new robot-assisted technique in surgery for large and medium-sized ventral midline hernias has brought tangible benefits to patients in terms of Textbook outcome, length of stay, complications and recurrence, compared to open technique and conventional laparoscopic technique. In addition, the investigators will assess the health economic aspects of the different techniques.
Read the detailed description
In the Stockholm Region, ventral hernia surgeries are performed at Södersjukhuset, Danderyds Hospital, Södertälje Hospital, Norrtälje Hospital, St Göran Hospital, Ersta Hospital and Karolinska Hospital. The hospitals differ in terms of admission areas, profile areas and access to surgical robots for hernia surgery. Since the introduction of robot-assisted surgery in Stockholm around 2017-2018, Södersjukhuset and Danderyd Hospital have used this technology to varying extents for ventral hernia, while the other hospitals have only offered open and conventional laparoscopic surgery. There is no established distribution of hernia patients in the region and no joint treatment conferences. The patients have therefore been distributed primarily depending on place of residence and referral patterns between the hospitals, which has also influenced the choice of method. Similar hernia patients have thus been offered different surgical treatments depending on which hospital in Stockholm the patient was treated at.
The robotic platform involves significant investment costs and costs for robotic instruments. Several studies also indicate that the surgical time is often longer, which can also increase costs. However, the promising results with shorter hospital stay and fewer complications could outweigh the increased surgical costs that have been demonstrated in several studies. The investigators will compare the costs of robot-assisted ventral hernia surgery in the operating room, in the hospital and after discharge with the corresponding costs for open and conventional laparoscopic surgery. Cost-effectiveness analyses will be performed.
- Conditions
- Ventral Hernia
- Keywords
- laparoscopic surgery, robot-assisted surgery, ventral hernia, surgery
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open surgery | Patents who had open surgery for their ventral hernia | |
| Conventional laparoscopic surgery | Patents who had conventional laparoscopic surgery for their ventral hernia | |
| Robot-assisted laparoscopic surgery | Patents who had robot-assisted laparoscopic surgery for their ventral hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with Textbook Outcome
Textbook Outcome is a composite outcome that will be used as a measure of a problem-free postoperative recovery. Textbook Oitcome will be defined as the absence of complications, prolonged hospital stay, readmission, and reoperation. Textbook Outcome is a binary outcome measure; the patient will either have Textbook Outcome (i.e. a problem-free postoperative recovery) or not (i.e. not a problem-free postoperative recovery).
Measured: 1 month post surgery
Secondary outcomes (4)
Rate of.post operative complications
Post operative complications defined as Clavien-Dindo grade III or higher
Measured: 1 month post surgery
Recurrence
A recurrence of the patients ventral hernia. Re-operation will be used as a proxy for recurrence.
Measured: 2-7 years post surgery
Length of stay
Length of hospital stay for the surgery
Measured: Perioperatively
Cost
The costs of the three different surgical methods for ventral hernias. Cost-effectiveness calculations will be performed.
Measured: Up to 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Jan 2018
- Primary completion31 Jan 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andreas Älgå
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyds Hospital, Stockholm, Sweden, Sodertalje Hospital, Ersta Hospital, Sweden, Stockholm South General Hospital
- Responsible party
- Sponsor-investigator, Andreas Älgå, Karolinska Institutet
- Investigators
- Andreas Älgå, MD, PhD, Principal investigator, Karolinsk Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275346
- Sponsor's protocol ID
- VH-OpenLapRob
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Surgical Approaches for Medium-to-Large Ventral Hernias: Open, Laparoscopic, and Robotic-Assisted Techniques
- ClinicalTrials.gov ID
- NCT07275346
- Acronym / sponsor ID
- VH-OpenLapRob
- Conditions
- Ventral Hernia
- Keywords
- laparoscopic surgery, robot-assisted surgery, ventral hernia, surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Andreas ÄlgåUniversity, hospital or other
- Collaborators
- Danderyds Hospital, Stockholm, Sweden, Sodertalje Hospital, Ersta Hospital, Sweden, Stockholm South General Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Dec 2025 (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.
The purpose of this project is to investigate whether the use of the new robot-assisted technique in surgery for large and medium-sized ventral midline hernias has brought tangible benefits to patients in terms of Textbook outcome, length of stay, complications and recurrence, compared to open technique and conventional laparoscopic technique. In addition, the investigators will assess the health economic aspects of the different techniques.
Detailed description
In the Stockholm Region, ventral hernia surgeries are performed at Södersjukhuset, Danderyds Hospital, Södertälje Hospital, Norrtälje Hospital, St Göran Hospital, Ersta Hospital and Karolinska Hospital. The hospitals differ in terms of admission areas, profile areas and access to surgical robots for hernia surgery. Since the introduction of robot-assisted surgery in Stockholm around 2017-2018, Södersjukhuset and Danderyd Hospital have used this technology to varying extents for ventral hernia, while the other hospitals have only offered open and conventional laparoscopic surgery. There is no established distribution of hernia patients in the region and no joint treatment conferences. The patients have therefore been distributed primarily depending on place of residence and referral patterns between the hospitals, which has also influenced the choice of method. Similar hernia patients have thus been offered different surgical treatments depending on which hospital in Stockholm the patient was treated at.
The robotic platform involves significant investment costs and costs for robotic instruments. Several studies also indicate that the surgical time is often longer, which can also increase costs. However, the promising results with shorter hospital stay and fewer complications could outweigh the increased surgical costs that have been demonstrated in several studies. The investigators will compare the costs of robot-assisted ventral hernia surgery in the operating room, in the hospital and after discharge with the corresponding costs for open and conventional laparoscopic surgery. Cost-effectiveness analyses will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open surgery | – | –Patents who had open surgery for their ventral hernia |
| Conventional laparoscopic surgery | – | –Patents who had conventional laparoscopic surgery for their ventral hernia |
| Robot-assisted laparoscopic surgery | – | –Patents who had robot-assisted laparoscopic surgery for their ventral hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients registered in the Swedish Abdominal Hernia Registry and operated on at Södersjukhuset, Ersta Hospital, Danderyd Hospital, or Södertälje Hospital
Key inclusion criteria (1 listed)
- Large and medium-sized midline hernias (EHS classification W2-W3)
Key exclusion criteria (1 listed)
- Hernia operations combined with bowel procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
% of patients with Textbook Outcome
Time frame: 1 month post surgery
Textbook Outcome is a composite outcome that will be used as a measure of a problem-free postoperative recovery. Textbook Oitcome will be defined as the absence of complications, prolonged hospital stay, readmission, and reoperation. Textbook Outcome is a binary outcome measure; the patient will either have Textbook Outcome (i.e. a problem-free postoperative recovery) or not (i.e. not a problem-free postoperative recovery).
4 secondary outcomes
Rate of.post operative complications
Time frame: 1 month post surgery
Recurrence
Time frame: 2-7 years post surgery
Length of stay
Time frame: Perioperatively
Cost
Time frame: Up to 1 year post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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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.
Andreas Älgå, MD, PhD principal investigator
Karolinsk Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia, run by Andreas Älgå at 1 site in Sweden.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
% of patients with Textbook Outcome (time frame: 1 month post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.