Clinical trial NCT05906017: Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome
Official title: Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Hernia
Keywords: Da Vinci
Robot
Umbilical hernia
Ventral hernia
Epigastric hernia
Hernia repair
Laparotomy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of stay (LOS)
timeFrame: Up until 3 months
Secondary outcomes:
measure: Operating time
timeFrame: Time from first incision to wound closure
measure: Change in Surgical stress response (CRP)
timeFrame: measured at baseline preoperatively, 30 minutes after extubation, 120 minutes after extubation and on day 1 and 3.
measure: Hernia defect size
timeFrame: Measured preoperatively
measure: Intraoperative need of blood transfusion
timeFrame: From first incision until last suture has been placed
measure: Change in surgical stress response (Interleukins)
timeFrame: Measured at baseline preoperatively and up until 120 minutes after extubation on day 1 and 3.
measure: Treatment cost
timeFrame: From inclusion until 6 months postoperatively
measure: Change in satisfaction and quality of life
timeFrame: [Time Frame: From inclusion until 6 months after operation.]
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Sygehus Sønderjylland
state: Southern Denmark
Study officials:
affiliation: Hospital of Southern Denmark - Aabenraa
name: Michael Festersen Nielsen
role: STUDY_DIRECTOR
References: