An interventional study of Open Hernia surgery and Robotic Hernia surgery in Abdominal Hernia, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment
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.
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's enrollment of 56 is below the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.
Compared within Hernia, Ventral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hernia, Abdominal. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open ventral hernia repair
Procedure: Open Hernia surgery
Robotic-assisted ventral hernia repair
Procedure: Robotic Hernia surgery
midline ventral hernia repair - open
midline ventral hernia repair - robotic
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
Time frame: Up until 3 months
Operating time
Measured in minutes
Time frame: 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
Time frame: 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.
Time frame: Measured preoperatively
Intraoperative need of blood transfusion
The amount of blood transfused during surgery measured in mL
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: [Time Frame: From inclusion until 6 months after operation.]
Plan to share: No
Ran from May 2023 to primary completion in Apr 2025, 23 months.
Of 75 non-industry interventional studies with no phase under Hernia, Ventral, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's 23 months is below that.
Counting every sponsor, half of 88 studies reached it within 37 months; a quarter within 19 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Southern Denmark →