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OpenTrials
Completed

NCT Number: NCT05906017

Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sygehus Sønderjylland

Aabenraa, Southern Denmark, 6200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Hernia surgery

Procedure

midline ventral hernia repair - open

Robotic Hernia surgery

Procedure

midline ventral hernia repair - robotic

Primary outcomes

  1. Length of stay (LOS)

    Time frame: 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 outcomes

  1. Operating time

    Time frame: Time from first incision to wound closure

    Measured in minutes

  2. Change in Surgical stress response (CRP)

    Time frame: 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

  3. Hernia defect size

    Time frame: Measured preoperatively

    Hernia defect size measured in mm either on CT scan or intraoperative.

  4. Intraoperative need of blood transfusion

    Time frame: From first incision until last suture has been placed

    The amount of blood transfused during surgery measured in mL

  5. Change in surgical stress response (Interleukins)

    Time frame: 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)

  6. Treatment cost

    Time frame: From inclusion until 6 months postoperatively

    Cost analysis of the two types of treatment

  7. Change in satisfaction and quality of life

    Time frame: [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)

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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