Short summary

In this randomized clinical trial, we compare the conventional open repair for hernia in the anterior abdominal wall with the robotic-assisted approach. 110 patients with midline abdominal wall defects will be randomized to either open or robotic-assisted surgery. We examine short and long-term complications through follow up with clinical assessment as well as patient reported outcome measures including pain, cosmetic appearance, overall patient satisfactory.

Rationale

Ventral hernias occur in up to 25 percent 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 repair was 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 the 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.

The Study aims to assess the short and long-term results following primary midline ventral hernia repair and to determine whether the incidence of these postoperative complications differ between the open and the robotic-assisted procedure. The abdominal hernia questionnaire will be used to assess patient reported outcome measures, which is the primary outcome of the trial. The effect on the surgical stress response will be determined by measuring CRP and a variety of inflammatory and cytokine markers. A cost-effectiveness analysis will be performed comparing the robotic-assisted approach to the open repair.

Description of the cohort

Study subjects will be recruited among patients that have been referred to the outpatient clinic for assessment of a possible ventral hernia. Patients will be presented with the opportunity of participation in the trial at the outpatient interview at surgical department, Hospital of Southern Jutland. This can occur when a clear clinical or radiological diagnosis is proven and the inclusion- and exclusion criteria are met.

Data and biological material

The preoperative assessment will consist of information concerning demographics (age, gender, BMI, ASA-score, comorbidities), type of planned operation and date of randomization and operation as well as patient reported quality of life/satisfaction questionnaire(AHQ).

- Demographics

- Age and sexp

- ASA-scorep

- BMIp

- Comorbiditiesp

The perioperative data assessment will consist of :

- Intra and postoperative outcomes

- Requirement of blood transfusion (mL)

- Estimated intra-operative blood loss (mL)

- Hernia defect size, measured at (8 mmHg)

- Postoperative length of stay

- Total surgical time (minutes)

- Total anesthesia time (minutes)

- Postoperative analgesics

- Any postoperative complications:

Surgical complications:

- Hematoma, seroma, wound infection, hernia recurrence, pain.

Medical Complications:

- Cerebral stroke

- STEMI/NON-STEMI

- aspiration pneumonia

- heart insufficiency

- pulmonary embolism

- respiratory failure

- renal insufficiency

- sepsis

- deep vein thrombosis

- arterial thromboembolism

- or other medical complications.

The perioperative data obtained from patient records will be used to compare complication rates and morbidity of the two surgical methods.

The patients written consent gives the trial manager, sponsor and sponsor's representatives as well as any supervisory authority direct access to obtain information in the patient's medical record, etc., including electronic medical records, in order to see information about the subject's health, which is necessary as part of the implementation of the research project and for control purposes, including self-control, quality control and monitoring, which they are obliged to carry.

Blood samples will be obtained preoperatively when included from the outpatient clinic or on the day of admission, 30 and 120 minutes after arrival in the recovery room following the procedure and on postoperative day 1 and 3. Serum for analysis will collected in NUC-vails and stored at -80 degrees Celsius. The cytokine panel to be measured will consist of CRP, IL-1β, IL-6, IL-8, IL-10, and TNF-α. CRP will be measured preoperatively and postoperatively on day 1 and 3. 14,5 mL venous blood will be taken in separator gel collection tubes, after which the samples will be centrifuged. The total amount of blood taken per patient during the course of the study will be 72,5 mL. The serum will be collected and transferred to cryotubes and immediately frozen to -80 degrees Celsius. The samples will be stored in a OPEN biobank at SHS with unique identification numbers. When all study samples have been collected (assumed to be completed after 24 months), the vials will be transferred to freezer boxes containing dry ice and transported to the neurobiological department, University of Southern Denmark for analysis. All samples are collected and subsequently analyzed at once to ensure uniform handling and analysis of the samples. All samples will be destroyed after the analyses have been performed and will not be stored for future research.

The blood sample on the 1st and 3rd postoperative day will be conducted by a doctor or a nurse from the study group and will also involve a clinical evaluation in order to detect any postoperative complications.

Collaborating researchers and departments

Department of Surgery Sygehus Lillebælt

• Martin Kobborg