Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open repair | Active Comparator | Open ventral hernia repair |
|
| Robotic-assisted repair | Experimental | Robotic-assisted ventral hernia repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Hernia surgery | Procedure | midline ventral hernia repair - open |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up until 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | Measured in minutes | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Festersen Nielsen | Hospital of Southern Denmark - Aabenraa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sygehus Sønderjylland | Aabenraa | Southern Denmark | 6200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41925930 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006554 | Hernia, Umbilical |
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Robotic Hernia surgery |
| Procedure |
midline ventral hernia repair - robotic |
|
| 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 preoperatively |
| Intraoperative need of blood transfusion | The amount of blood transfused during surgery measured in mL | 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 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 | 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: From inclusion until 6 months after operation.] |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |