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NCT Number: NCT07275346

Surgical Approaches for Medium-to-Large Ventral Hernias: Open, Laparoscopic, and Robotic-Assisted Techniques

The purpose of this project is to investigate whether the use of the new robot-assisted technique in surgery for large and medium-sized ventral midline hernias has brought tangible benefits to patients in terms of Textbook outcome, length of stay, complications and recurrence, compared to open technique and conventional laparoscopic technique. In addition, the investigators will assess the health economic aspects of the different techniques.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet, Södersjukhuset

Stockholm, 11883, Sweden

About this study

In the Stockholm Region, ventral hernia surgeries are performed at Södersjukhuset, Danderyds Hospital, Södertälje Hospital, Norrtälje Hospital, St Göran Hospital, Ersta Hospital and Karolinska Hospital. The hospitals differ in terms of admission areas, profile areas and access to surgical robots for hernia surgery. Since the introduction of robot-assisted surgery in Stockholm around 2017-2018, Södersjukhuset and Danderyd Hospital have used this technology to varying extents for ventral hernia, while the other hospitals have only offered open and conventional laparoscopic surgery. There is no established distribution of hernia patients in the region and no joint treatment conferences. The patients have therefore been distributed primarily depending on place of residence and referral patterns between the hospitals, which has also influenced the choice of method. Similar hernia patients have thus been offered different surgical treatments depending on which hospital in Stockholm the patient was treated at.

The robotic platform involves significant investment costs and costs for robotic instruments. Several studies also indicate that the surgical time is often longer, which can also increase costs. However, the promising results with shorter hospital stay and fewer complications could outweigh the increased surgical costs that have been demonstrated in several studies. The investigators will compare the costs of robot-assisted ventral hernia surgery in the operating room, in the hospital and after discharge with the corresponding costs for open and conventional laparoscopic surgery. Cost-effectiveness analyses will be performed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Large and medium-sized midline hernias (EHS classification W2-W3)

Exclusion criteria

  • Hernia operations combined with bowel procedures

Treatment and study plan

Primary outcomes

  1. % of patients with Textbook Outcome

    Time frame: 1 month post surgery

    Textbook Outcome is a composite outcome that will be used as a measure of a problem-free postoperative recovery. Textbook Oitcome will be defined as the absence of complications, prolonged hospital stay, readmission, and reoperation. Textbook Outcome is a binary outcome measure; the patient will either have Textbook Outcome (i.e. a problem-free postoperative recovery) or not (i.e. not a problem-free postoperative recovery).

Secondary outcomes

  1. Rate of.post operative complications

    Time frame: 1 month post surgery

    Post operative complications defined as Clavien-Dindo grade III or higher

  2. Recurrence

    Time frame: 2-7 years post surgery

    A recurrence of the patients ventral hernia. Re-operation will be used as a proxy for recurrence.

  3. Length of stay

    Time frame: Perioperatively

    Length of hospital stay for the surgery

  4. Cost

    Time frame: Up to 1 year post surgery

    The costs of the three different surgical methods for ventral hernias. Cost-effectiveness calculations will be performed.

Sponsors and collaborators

Lead sponsor

Andreas Älgå

Other

Collaborators

  • Danderyds Hospital, Stockholm, Sweden
  • Ersta Hospital, Sweden
  • Sodertalje Hospital
  • Stockholm South General Hospital

Registry information

Official study title

Evaluating Surgical Approaches for Medium-to-Large Ventral Hernias: Open, Laparoscopic, and Robotic-Assisted Techniques

Important dates

Study start
2018
Primary completion
2024
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

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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