Abdominal HerniaNCT05906017
Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome
A study testing Open Hernia surgery and Robotic Hernia surgery in people with Abdominal Hernia, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
In this randomized clinical trial, the investigators will compare the conventional open repair for hernia in the anterior abdominal wall with the robotic-assisted approach. 60 patients with midline abdominal wall defects will be randomized to either open or robotic-assisted surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Hernia
- What is being tested?
- Open Hernia surgery and Robotic Hernia surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2023to 25 Oct 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18
- ASA 1-3
- Clinical and radiologic diagnosis of midline ventral hernia
- Eligible to surgery according to a preoperative anaesthetic assessment
- Informed consent
- Able to understand written and oral Danish language
Who cannot join
- Incarcerated ventral hernia requiring emergency surgery
- Pregnancy
- Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of analgesics (paracetamol, NSAID, opiates etc).
- Current cancer diagnosis
- History of psychiatric or addictive disorder that prevents the patient from participating in the trial
- Co-existing inflammatory disease
- Co-existing immunological disease that requires medication of any kind
- BMI >40 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
In this randomized clinical trial, the investigators will compare the conventional open repair for hernia in the anterior abdominal wall with the robotic-assisted approach. 60 patients with midline abdominal wall defects will be randomized to either open or robotic-assisted surgery. The investigators will examine short and long-term complications through follow-up with clinical assessment as well as patient-reported outcome measures including pain, cosmetic appearance, and overall patient satisfaction. Furthermore, the investigators will study the difference in surgical stress response between the two methods measured from a variety of different biomarkers before and after the operation. A cost-effective analysis will be conducted for the robotic and open procedure.
Read the detailed description
Ventral hernias occur in up to 25% of the population. They are diverse in severity ranging from small umbilical hernias to large abdominal wall defects that may result in loss of domain. Approximately one-third are incisional hernias. Incisional hernias are usually more complex due to complications from previous surgery. The procedure may be complicated as a result of intraabdominal bowel adhesions and adhesions within the hernial sac. These factors cause discomfort and may complicate the repair. Ventral hernias may be repaired either through a minimally invasive laparoscopic procedure or an open approach. The laparoscopic repair was introduced in the 1990s and in 2003 the first robotic-assisted procedure was described in a porcine model. In 2012 the first series of robotic repairs were reported in humans. Due to the superior flexibility of the robotic instruments, there is a substantial interest in harnessing the advantages of the robotic platform. Because robotic repair differs in several technical aspects from the open approach, it is important to determine whether the short and long-term results differ between the two procedures. Furthermore, it remains unresolved whether the robotic procedure is able to provide comparable outcomes to the open repair when assessed for quality-of-life outcome measures. These questions are important to address in order to determine the most appropriate surgical options for individual patients.
- Conditions
- Abdominal Hernia
- Being tested
- Open Hernia surgery, Robotic Hernia surgery
- Keywords
- Da Vinci, Robot, Umbilical hernia, Ventral hernia, Epigastric hernia, Hernia repair, Laparotomy
- Medical subject headings
- Hernia, Abdominal, Hernia, Umbilical, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Hernia surgeryProcedure or surgery
midline ventral hernia repair - open
Robotic Hernia surgeryProcedure or surgery
midline ventral hernia repair - robotic
| Study group | Role | What they receive |
|---|---|---|
| Open repair | Active comparator | Open ventral hernia repair Receives: Procedure: Open Hernia surgery |
| Robotic-assisted repair | Experimental | Robotic-assisted ventral hernia repair Receives: Procedure: Robotic Hernia surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay (LOS)
The primary outcome measure will be assessed by reviewing the electronic patient journal system. The day of the procedure will be recorded as day 0
Measured: Up until 3 months
Secondary outcomes (7)
Operating time
Measured in minutes
Measured: Time from first incision to wound closure
Change in Surgical stress response (CRP)
The degree of systemic inflammatory response expressed by C- reactive protein in serum
Measured: measured at baseline preoperatively, 30 minutes after extubation, 120 minutes after extubation and on day 1 and 3.
Hernia defect size
Hernia defect size measured in mm either on CT scan or intraoperative.
Measured: Measured preoperatively
Intraoperative need of blood transfusion
The amount of blood transfused during surgery measured in mL
Measured: From first incision until last suture has been placed
Change in surgical stress response (Interleukins)
The degree of systemic inflammatory response expressed by cytokine levels in serum. All measurements will consist of weight/volume ratio (eg. CRP mg/L and IL-6 pg/mL)
Measured: Measured at baseline preoperatively and up until 120 minutes after extubation on day 1 and 3.
Treatment cost
Cost analysis of the two types of treatment
Measured: From inclusion until 6 months postoperatively
Change in satisfaction and quality of life
Satisfaction and quality of life were measured preoperatively at the outpatient clinic using the "abdominal hernia questionnaire" (AHQ) translated into Danish. The AHQ has 4 possible answers (All of the time, Most of the time, Some of the time, None the time OR Strongly disagree, Somewhat disagree, Somewhat agree, Strongly agree OR Very unsatisfied, Somewhat dissatisfied, Somewhat satisfied, Very satisfied)
Measured: [Time Frame: From inclusion until 6 months after operation.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 May 2023
- Primary completion25 Apr 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal HerniaStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Festersen Nielsen, Study director, Hospital of Southern Denmark - Aabenraa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906017
- Sponsor's protocol ID
- SHS-MT Kir-2-2023
- Status last verified
- May 2026
- First submitted
- 23 May 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nielsen KA, Valorenzos A, Tsigka E, Frandsen CH, Helligso P, Petersen SR, Ellebaek MB, Nielsen MF. Open versus robotic-assisted repair of midline ventral hernias with defect width 2-8 cm - a randomized clinical trial (OVER). Hernia. 2026 Apr 2;30(1):155. doi: 10.1007/s10029-026-03617-7.
PubMed 41925930
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome
- ClinicalTrials.gov ID
- NCT05906017
- Acronym / sponsor ID
- SHS-MT Kir-2-2023
- Conditions
- Abdominal Hernia
- Keywords
- Da Vinci, Robot, Umbilical hernia, Ventral hernia, Epigastric hernia, Hernia repair, Laparotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 15 Jun 2023 (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.
In this randomized clinical trial, the investigators will compare the conventional open repair for hernia in the anterior abdominal wall with the robotic-assisted approach. 60 patients with midline abdominal wall defects will be randomized to either open or robotic-assisted surgery. The investigators will examine short and long-term complications through follow-up with clinical assessment as well as patient-reported outcome measures including pain, cosmetic appearance, and overall patient satisfaction. Furthermore, the investigators will study the difference in surgical stress response between the two methods measured from a variety of different biomarkers before and after the operation. A cost-effective analysis will be conducted for the robotic and open procedure.
Detailed description
Ventral hernias occur in up to 25% of the population. They are diverse in severity ranging from small umbilical hernias to large abdominal wall defects that may result in loss of domain. Approximately one-third are incisional hernias. Incisional hernias are usually more complex due to complications from previous surgery. The procedure may be complicated as a result of intraabdominal bowel adhesions and adhesions within the hernial sac. These factors cause discomfort and may complicate the repair. Ventral hernias may be repaired either through a minimally invasive laparoscopic procedure or an open approach. The laparoscopic repair was introduced in the 1990s and in 2003 the first robotic-assisted procedure was described in a porcine model. In 2012 the first series of robotic repairs were reported in humans. Due to the superior flexibility of the robotic instruments, there is a substantial interest in harnessing the advantages of the robotic platform. Because robotic repair differs in several technical aspects from the open approach, it is important to determine whether the short and long-term results differ between the two procedures. Furthermore, it remains unresolved whether the robotic procedure is able to provide comparable outcomes to the open repair when assessed for quality-of-life outcome measures. These questions are important to address in order to determine the most appropriate surgical options for individual patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open repair | Active comparator | Procedure: Open Hernia surgeryOpen ventral hernia repair |
| Robotic-assisted repair | Experimental | Procedure: Robotic Hernia surgeryRobotic-assisted ventral hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥18
- ASA 1-3
- Clinical and radiologic diagnosis of midline ventral hernia
- Eligible to surgery according to a preoperative anaesthetic assessment
- Informed consent
Key exclusion criteria (8 listed)
- Incarcerated ventral hernia requiring emergency surgery
- Pregnancy
- Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of analgesics (paracetamol, NSAID, opiates etc).
- Current cancer diagnosis
- History of psychiatric or addictive disorder that prevents the patient from participating in the trial
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 |
|---|---|---|
| Open Hernia surgerymidline ventral hernia repair - open | Procedure or surgery | Open repair |
| Robotic Hernia surgerymidline ventral hernia repair - robotic | Procedure or surgery | Robotic-assisted repair |
Primary outcome
Length of stay (LOS)
Time frame: Up until 3 months
The primary outcome measure will be assessed by reviewing the electronic patient journal system. The day of the procedure will be recorded as day 0
7 secondary outcomes
Operating time
Time frame: Time from first incision to wound closure
Change in Surgical stress response (CRP)
Time frame: measured at baseline preoperatively, 30 minutes after extubation, 120 minutes after extubation and on day 1 and 3.
Hernia defect size
Time frame: Measured preoperatively
Intraoperative need of blood transfusion
Time frame: From first incision until last suture has been placed
Change in surgical stress response (Interleukins)
Time frame: Measured at baseline preoperatively and up until 120 minutes after extubation on day 1 and 3.
Treatment cost
Time frame: From inclusion until 6 months postoperatively
Change in satisfaction and quality of life
Time frame: [Time Frame: From inclusion until 6 months after operation.]
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 14 May 2026.
- Derived from this study: PubMed 41925930Nielsen KA, Valorenzos A, Tsigka E, Frandsen CH, Helligso P, Petersen SR, Ellebaek MB, Nielsen MF. Open versus robotic-assisted repair of midline ventral hernias with defect width 2-8 cm - a randomized clinical trial (OVER). Hernia. 2026 Apr 2;30(1):155. doi: 10.1007/s10029-026-03617-7.
- Individual participant dataSharing planned: No
Related trials for Abdominal Hernia
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
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.
Michael Festersen Nielsen study director
Hospital of Southern Denmark - Aabenraa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Hernia surgery and Robotic Hernia surgery in people with Abdominal Hernia, run by University of Southern Denmark at 1 site in Denmark.
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 6 inclusion and 8 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 14 May 2026. 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 Denmark. 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?
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?
Length of stay (LOS) (time frame: Up until 3 months). 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 NCT05906017, which also lists 1 linked publication.
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 14 May 2026.