Abdominal Hernia
Conditions
Keywords
Da Vinci, Robot, Umbilical hernia, Ventral hernia, Epigastric hernia, Hernia repair, Laparotomy
Brief 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. 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.
Interventions
PROCEDUREOpen Hernia surgery
midline ventral hernia repair - open
PROCEDURERobotic Hernia surgery
midline ventral hernia repair - robotic
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay (LOS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating time | Time from first incision to wound closure | Measured in minutes |
| Change in Surgical stress response (CRP) | measured at baseline preoperatively, 30 minutes after extubation, 120 minutes after extubation and on day 1 and 3. | The degree of systemic inflammatory response expressed by C- reactive protein in serum |
| Hernia defect size | Measured preoperatively | Hernia defect size measured in mm either on CT scan or intraoperative. |
| Intraoperative need of blood transfusion | From first incision until last suture has been placed | The amount of blood transfused during surgery measured in mL |
| Change in surgical stress response (Interleukins) | Measured at baseline preoperatively and up until 120 minutes after extubation on day 1 and 3. | 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) |
| Treatment cost | From inclusion until 6 months postoperatively | Cost analysis of the two types of treatment |
| Change in satisfaction and quality of life | [Time Frame: From inclusion until 6 months after operation.] | 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) |
Countries
Denmark
Contacts
STUDY_DIRECTORMichael Festersen Nielsen
Hospital of Southern Denmark - Aabenraa
Outcome results
None listed